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FDA registered medical device manufacturers, page 3

The full list. FDA registered medical device manufacturers and other establishments: 25,781 rows, $337.81, or the new rows each week for $19 a month. Pay by card with no account. Prices exclude VAT. CSV and Excel files with the columns this page does not show (establishment name, FDA registration number, FEI number, street, city, state and 14 more), which open on your screen as soon as the payment clears and come by email. For agents and scripts: every list with its row count and price is at https://specstream.ai/data/lists.json.

Updated November 9, 2026. Source: openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files).

Device types, 3,001 to 4,142 of 4,142, in the same order as page 1.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the manufacturers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Device types, page 3

DeviceProduct codeManufacturersCountriesRecall events
Skull plate anvilGXM650
Mastoid gaugeJYI650
Rotary bone cutting handpieceKMW653
Cranial distraction systemPBJ630
Absorbable stapleMNU620
Cellulite appearance laserOYW630
Reprocessed electrode recording catheterNLH6117
Endoscopic storage coverOCU641
Vocal cord medialization systemMIX611
Anesthetic conduction filterBSN661
LOSLOS642
External vein stripperDWQ622
Teaching attachment for endoscopeFEA630
Multiple biochemical test culture mediaJSE620
Antibiotic assay culture mediaJSA630
Fibrinogen testGIS620
Glucose tolerance drinkMRV612
Sickle cell testGHM623
Turbidimetric, Total ProteinJGQ641
Volume plethysmographJEH640
Diagnostic flexible fresnel lensHJJ650
Umbilical clamp and cutterNBZ630
Yeast identification kitJXB635
Periodic acidKKS621
GlutaraldehydeIFT620
Surgical cardiac ablation device for treatment of atrial fibrillationOCM610
Suprapubic drainage tubeFFA633
Ultrasound wound cleanerNRB610
Tester, Electrode/Lead, ElectroencephalographGYA630
Radiographic intensifying screenEAM641
Scented-deodorized scented menstrual tamponHIL630
Eye sphere implantHPZ644
Evoked response mechanical stimulatorGZP640
Intraoperative orthopedic joint assessment aidONN653
Drug-eluting superficial femoral artery stentNIU622
Endoprosthesis portosystemic shuntMIR640
Arterial iliac covered stentPRL635
Cutaneous tissue adhesive with meshOMD620
Adjunctive use implanted continuous glucose monitorQCD620
Irrigation kit (wounds)PXY640
Abnormal hemoglobin controlJCM641
Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To TransplantationQQK631
System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia), ThermotherapyMEQ638
Electrocardiographic surface electrode testerKRC630
Control antigen indirect immunofluorescent multiple autoantibodiesDBL611
Electrosurgical deviceDWG630
Tumor treatment low electric field stimulatorNZK640
Skull tong for tractionHAX643
Implanted subcortical electrical stimulator (motor disorders)MRU622
Anterior staple as supplemental fixation for fusionPHQ630
Abdominal hernia absorbable surgical meshOWT630
NSXNSX6418
Control antiserum antigen alpha-1 microglobulinMGA631
Dengue virus antigen assayQCU620
Non-diagnostic qualitative test for HLAMZI620
Patient isolation chamberLGM621
Polymerizing sealantNBE626
Administrations sets with neuraxial connectorsPWH630
Deployer surgical meshORQ620
Esophageal dilator balloon with or without electrode sensorsPID631
Microbial growth monitorJTA630
A chemical vapor sterilization multivariable chemical indicatorQKM630
Corneal storage mediaLYX640
Electrocardiograph lead switching adaptorDRW630
Electroencephalogram signal spectrum analyzerGWS640
Spinal-fluid manometerFMJ632
Formol calcium solutionIGD630
Urinary calculi qualitative chemical reactions (stone)JNQ620
Chromatographic Separation, Cpk IsoenzymesJHT610
Heart-valve test probeLXN650
Reagents, Monkeypox Virus Nucleic Acid.QTP610
Formalin-salineIGC640
Applicator for rectal suppositoryOOW630
Percutaneous introducer kitPXB621
Uterine tenaculum (exempt)PUA640
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-FilledFTR624
Pacemaker test magnetDTG640
Non-remote illuminatorFTF640
Whole blood hemoglobin determinationKHG631
Bilirubin enzymatic methodJFM623
Paraffin melting point apparatusIDT641
Auramine OKJK620
Oil red OHZG620
Trypan blueLGY630
Powered parallel barsIRR630
Acid Phosphatase (Prostatic), Tartrate InhibitedJFH631
Blood Pump For Ecmo, Long-Term (> 6 Hours) UseQNR642
Neurovascular liquid embolic agentSGU620
Mesh, Surgical, Collagen, Large Abdominal Wall DefectsOXK620
Negative pressure wound therapy device for reduction of wound complicationsQFC641
Prep kitPXD620
Snake bite suction kitKYP640
Urine transport kit (excludes HIV testing)OHZ650
Umbilical catheter insertion trayPXJ640
General purpose instrument trayPXV640
Blood transfusion kitPOQ621
Gas pressure transducerBXO650
Nucleic acid amplification test for the quantitation of epstein-barr virus (EBV) DNAQLX620
Human immunodeficiency virus (HIV) viral load monitoring testQUM610
Saccharogenic, AmylaseCIJ621
Alpha-fetoprotein test kit for neural tube defectsLOK641
Quality Control Material, Genetics, DnaNZB630
Air-handling apparatus accessoryQGI640
Microspheres radionuclideNAW644
Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile, ExemptPTX630
Nasogastric tubeBSS631
Enzyme linked immunoabsorbent assay (chlamydiae group)LJC635
Igm (Mu Chain Specific), Antigen, Antiserum, ControlDAO650
Pacemaker service toolsDTF620
Calibrator, Pressure, GasBXX610
Endoscopic television camera with audioFWG630
Prescription use blood glucose meter for near-patient testingPZI642
Percutaneous nerve stimulator for opioid withdrawalPZR631
Sliding microtomeKFL640
Metal total talus replacement prosthesisQNN630
Soft tissue detector diagnostic lightNXV630
Ion papersDMG620
Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/BrothJTZ618
Negative pressure wound therapy non-powered suction apparatusOKO630
Control antiserum antigen complement C9DAE630
Herpes simplex virus nucleic acid amplification assayOQO631
Dengue serological reagentsOSU610
Obstetric table (and accessories)KNC658
Dialyzer reprocessing systemLIF611
Sudan IIIKKJ610
Mycobacteria identification kitJSY621
All leptospira spp. antiseraGRX620
Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk AssessmentNSF621
Piezo-electric stimulator for relief of mosquito bite itchOSG630
Maddox lensHKR630
Simulatan (including crossed cylinder)HOR640
Preformed gold denture teethELN630
Impression earmold kitLDG620
Pain relief electromagnetic stimulatorQPL660
Quality control kit for culture mediaJTR6327
Procainamide enzyme immunoassayLAR630
Standards And Controls, Hemoglobin, Normal And AbnormalGFS610
Next generation sequencing based tumor profiling testPZM640
Diagnostic X-ray beam limiting deviceKPW640
Light, Wood'S, FluorescenceGMB640
Antimicrobial susceptibility test discsJTN6315
Tobramycin radioimmunoassayKLB641
Tissue sievesIDX620
Shock-wave generator for pain reliefNBN630
Non-electrical operating-room tableFWY640
Fetal hemoglobin assayKQI640
Multi function physical therapy tableJFB630
Gram-positive bacteria and their resistance markersPAM6311
Gram-negative bacteria and associated resistance markersPEN6318
Microsedimentation centrifugeGHK620
Glucose-6-Phosphate Dehydrogenase (Erythrocytic), ScreeningJBF621
Research Use Only/PathologyOTU651
Point of care HIV serology diagnostic and/or supplemental testQSU620
Implanted autonomic nerve stimulator for stroke rehabilitationQPY620
AC-powered retinoscopeHKL640
Coronary mechanical thrombectomy with aspirationQEX610
Nuclear sealed calibration sourceIXD630
Female urinary incontinence-control external urethral occluderMNG640
System, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality DetectionPFX632
Smear synthetic spraysIFI630
Leishmanii serological reagentLOO610
Radiological image processing software for ablation therapy planning and evaluationQTZ630
Intravenous catheter force-activated separation device.QOI620
Air fluidized bedINX646
Breathing system collection bottle (calibrated)CBD640
Photodynamic therapy laser systemMVF630
Percutaneously delivered tricuspid valve repair deviceNPS630
Assistive listening deviceLZI650
Radionuclide test-pattern phantomJAR620
Physiological signal based seizure monitoring systemPOS651
Lapping tool kitNYG530
Pediatric catheter for general and plastic surgeryGBN551
Fiberoptic photographic light sourceFCR530
AngioscopeLYK530
Vaginoscope and accessoriesMOK520
Bronchoscope biopsy forceps (rigid)JEK520
Carboxymethylcellulose sodium denture adhesive (40-100&)KOQ540
Cuff spreaderCBG520
Prosthesis, Shoulder, Humeral (Bipolar Hemi-Shoulder) Metal/Polymer, Cemented Or UncementedMJT510
Intra-pulmonary percussive vibration (IPV) devicesSDT520
Carpal scaphoid wrist prosthesisKWO510
Sinus trephineKBF540
Salpingeal curetteKBK530
Intraoral, Dental Foam ProtectorPFL540
ENT microruleKAH550
Catheter, Drainage, Intraoral/ExtraoralOAJ530
Cranioplasty material forming instrumentHBX551
Orbital compressorHOA520
Ocular esthesiometerHJC550
Colostomy spur crusherFHH540
Rectal catheter for continent ileostomyKPH540
Attic punchJYX540
Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-ConstrainedLZJ511
Airway pressure meter (inspiratory force)BXR520
Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, OsteoinductionNEK522
Deep brain stimulation for the treatment of dystoniaSGS520
Dental bone grafting material with biologic componentNPZ511
Stimulator, Tibial, Electrical, Implantable, For Urinary IncontinenceQPT520
Polymer finger prosthesisKWF510
ENT surgical head supportEPW520
Fetal vacuum extractorHDB534
Hemorrhoid cushionLRL530
Applicator (Laryngo-Tracheal), Topical AnesthesiaCCT524
Tube, Bronchial (W/Wo Connector)BTS533
Cardiopulmonary bypass marker (vein marker)MAB510
Surgical retractor kitPYH530
Paracentesis trayPYC533
Uricase uric acid (U.V.)CDO541
Diethyldithiocarbamate (Colorimetric), CopperJKZ521
Pregnancy truncal orthosisQSB540
Staphylococcus aureus screening kitJWX535
Extracorporeal photopheresis systemLNR5210
Phosphotungstic acid hematoxylinHZM510
Sudan black BHZZ510
Malachite greenKJY520
Implantable left atrial appendage clipPZX520
Cryogenic surgical deviceGXH522
Temporary Catheter, Embolic Protection, Transcatheter Intracardiac ProceduresPUM520
Gastrointestional tube holderPLI520
Pacemaker generator function analyzerDTC530
High Flow/High Velocity Humidified Oxygen Delivery DeviceQAV531
Liver biopsy kitPYA530
Extra-ocular orbital implantHQX541
Prescription denture cleanserNUX540
Adhesive, Denture, Carboxymethylcellulose Sodium (32%) And Ethylene-Oxide HomopolymerKOL540
Battery powered ophthalmic instrument standNOI530
Dental biologic materialNQA532
Coronary covered stentNIV540
Renal denervation ablation catheterQYI531
Ultrasound bronchoscopePSV522
Non-adjunctive use implanted glucose sensorQHJ521
Endoscope laryngoscopeGCI542
Endoscope automated cleaner washerNVE531
Venous ulcer kitPYK540
Tracheal suction setOFS530
Antigen and control anti-DNA antibodyLSW541
Platelet factor 4 radioimmunoassayLCO538
Implantable cardiac event recorder (without arrhythmia detection)MXC524
Electrical tumor treatment fields for non-small cell lung cancerSDA540
Low electric field generator for pancreatic cancer treatmentSHC540
Arteriosus patent ductus occluderMAE531
Reprocessed bronchoscopeQNW521
Non-absorbable or absorbable fixation for pelvic usePBQ531
Drug-coated peripheral transluminal angioplasty catheterPRC521
Deep brain stimulator for obsessive compulsive disorder (OCD)OLM520
Electrical tumor treatment fieldsQGZ540
Surgical hoodFXY552
Ultrasonic blood-flow monitorHEP520
Negative control serological kitMJY540
Lectins and protectinsKSI520
Automated cell-washing centrifuge for immuno-hematologyKSN520
Urea nitrogen photometric ureaseCDN512
Aspergillus spp. cf antigenJWT540
White-cell controlGGL510
Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally PlacedPAJ520
Autonomous Extracorporeal Blood Leak Detector/AlarmODX541
Plasma, Coagulase, Human, Horse And RabbitJTL530
Antiserum, Vibrio Cholerae, All VarietiesGSQ510
Malar implantLZK513
Fluid jet removal systemPZP522
Over-the-counter automated external defibrillatorNSA532
Signal isolation systemDRJ530
Electroencephalograph test signal generatorGWR530
Digital Physical/Chemical Sterilization Process SensorSBE510
Creatine conversion to creatinineJLA531
Kit, Test, Multiple, Drugs Of Abuse, Over The CounterMVO511
U.V. Spectrometry, Tricyclic Antidepressant DrugsLFH513
Staphylococcus spp. fluorescent antisera of all typesGTN520
C. difficile nucleic acid amplification test assayOMN512
System, Test, Tumor Marker, Monitoring, BladderMMW521
Vacuum powered body fluid collection kitOJR541
Custom anesthesia trayOGD536
Prosthesis, Breast, Inflatable, Internal, SalineFWM528
Vascular graft prosthesis of less then 6mm diameterDYF512
Deployment balloon surgical meshOQL520
Assisted reproduction laser systemMRX550
Thrombin time testGJA533
Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, ControlDBA531
Streptococcus spp. antideoxyribonucleaseGTR530
Control antiserum antigen plasminogenDDX540
U.V. Method, Cpk IsoenzymesJHW532
Hematoxylin weigert'sHYO520
Clearing oilIJZ540
Fuchsin acidIDF520
Brilliant cresyl blueKJN520
Osteocalcin test systemNEO541
Oxygenator, Long Term Support Greater Than 6 HoursBYS531
Tubing, Long Term Support Greater Than 6 HoursQWF530
Extracorporeal System For Long-Term Respiratory / Cardiopulmonary FailureQJZ532
LDQLDQ531
Clean-up kitPWU520
Cardiovascular catheter sheath introducer kitOEX522
Maternity kitPVT540
Basic set-up trayPXN530
Urinary drainage collection kitPPG531
Universal drainage trayPPD523
Tracheostomy kitOGW540
Feeding tube kitPRR531
Pure latex sheet drape with self-retaining finger cotEYX540
Laparoscopic gastrostomy kitPSD530
Catheter guide wire kitOFB522
Intracranial pressure & temperature monitoring kitPSP531
Denture repair kitEBO530
Gastro-urology biopsy kitPRV521
Vascular access port kitPXK520
Suction catheter kitPYG530
Electrosurgical and coagulation unit with accessoriesBWA520
Ophthalmoscopes, Replacement Batteries, Hand-HeldMSG530
Antimicrobial blood pressure cuffOED540
Nucleic acid amplification test for the quantitation of bk virus (BK) DNAQMI520
Reagents, Zika Virus Nucleic AcidPOA511
Cultured animal and human cellsKIR511
External programmable pacemaker pulse generator (for electrophysiological studies only)JOQ523
Parasite concentration deviceLKS510
Intraocular fluidLWL530
Iodine (tincture)IAL520
Stabilized enzyme solutionKSK550
Solution, Carnoy'SIGM510
Chlamydia spp. fluorescent antiseraLKI510
Electrical urinometerEXS526
Control antiserum antigen factor BJZH521
Oral sex std barrierMSC540
Pressure ulcer management toolQEF530
External upper limb tremor stimulatorQBC520
Extremity lymphedema extracellular fluid monitorOBH531
Endometrial aspiratorHFF520
Femoral catheterLFK522
Hollow fiber capillary dialyzerFJI524
Composite resin warmerQGO540
Prealbumin, Fitc, Antigen, Antiserum, ControlDDS520
Cream, Nasal, Topical, Mechanical Allergen Particle BarrierNUP540
Caloric-water stimulatorETP542
Surrogate calibratorJIW540
Uric acid test system for at home prescription usePTC521
Non-implanted nerve stimulator for pain associated with irritable bowel syndrome (IBS)QHH530
Intrauterine tamponade balloonOQY512
Micro mixerJRB531
Field generator positioning deviceQLV530
Non-electrical cysto tableEYH530
Culture media for isolation of pathogenic NeisseriaJTY518
Laparoscopic single port access deviceOTJ540
Lsd radioimmunoassay (125-I)DLB530
Test, Qualitative, Detection Of Dengue Igm And Igg AntibodiesNWY511
Shockwave intravascular lithotripsy systemQMG520
Research Use Only/MicrobiologyOTT531
Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection SystemPLO532
Interleukin 6QLC530
Antisera, Hai, Influenza Virus A, B, CGNS530
Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp.GNC522
Strip, Test, Reagent, Residuals For Dialysate, DisinfectantMSY510
2 herpesvirus hominis 1 cf antiseraGQO511
Varicella-zoster cf antigen (including cf control)GQW510
Mmp-9 test systemPFQ532
System, Test, Her-2/Neu, IhcMVC544
Fusion and stereoscopic targetHLP540
Sirolimus test systemNRP526
Culdoscopic coagulator (and accessories)HFI540
Diagnostic hruby fundus lensHJI541
Haidinger brush (including macular integrity)HIY550
Apheresis for focal glomerulosclerosis in adult and pediatric patientsPBN520
Removal low density lipoproteinMMY522
Manual patient rotation bedINY520
Poly vinyl chloride mechanical walker (PVC)NXE540
Genetic variant detection and health risk assessment systemPTA530
Insulin infusion pump to be used with invasive glucose sensorOYC5111
Non-adjunctive invasive glucose sensorPQF523
Quinidine enzyme immunoassayLBZ531
Mycophenolic acid test systemOAV530
Eye cupLXQ520
Reagents, Ebola Zaire Virus (Detected In The West Africa Outbreak In 2014) Nucleic AcidPOG510
Solution, Zenker'SIFH510
Catheter (Gastric, Colonic, Etc.), Irrigation And AspirationKDH522
High frequency ventilatorLSZ525
Intraoral X-ray unitEAP523
Aldosterone radioimmunoassayCJM530
Cardiopulmonary bypass level sensing monitor and/or controlDTW522
Digital pathology displayPZZ550
Counter (beta, gamma) for clinical useJJJ542
Radioimmunoassay, Immunoglobulins (D, E)JHR531
Bone sonometerMUA551
Cleaning germicide accessories for endoscopesNZA531
Tissue grinderLEC530
AC-powered projection tangent screenHOK530
Automated antimicrobial susceptibility test system for positive blood culture samplesSAN520
Device, Iontophoresis, Specific UsesKTB510
Tremor transducerGYD540
Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular AssaySEP530
Cardiopulmonary bypass defoamerDTP530
Cytokeratin fragments 21-1 eia kitOVK530
Glucagon radioimmunoassayJME540
System, Test, Radioallergosorbent (Rast) Immunological, Exempt AllergensPUW530
Control antiserum antigen whole blood plasmaDGQ510
N-acetylprocainamide enzyme immunoassayLAN531
Specific reagent nad-nadh for alcohol enzyme methodDML531
Cocaine enzyme immunoassayJXO530
Hydroxybutyric dehydrogenase alpha-ketobutyric and nadh acid (U.V.)JMK530
Titrimetric, Fatty AcidsJLH531
Acupuncture point locatorBWJ540
DNA genetic analyzerPCA540
Liquid chromatography columnsDPM550
Bagolini lensHPD540
Intestinal stimulatorLNQ521
Dental stereotaxic instrumentPLV524
CMV donor testMZE540
Diagnostic neurosurgical microscope filterQFX540
Over-the-counter integrated continuous glucose monitor for non-intensive glucose managementSBH520
Intrasaccular flow disruption deviceOPR511
Reduced ejection fraction machine learning-based notification softwareQYE510
Apparatus, Automated Blood Cell DilutingGKH532
Backup delivery nitric oxide apparatusMRO530
Nitrogen dioxide analyzerMRQ530
Nitric oxide analyzerMRP530
Mucoadhesive application protective coating for the rectal mucosaPHN540
Anti-stammering deviceKTH520
Powered eyelid cleaning spongePYU530
Posture chair for cardiac and pulmonary treatmentBYN540
Temperature regulated water mattressFOH550
Ophthalmic syringeQLY520
Vision image intensification aidHOT530
Portable wheelchair elevatorING541
Immunoassay for host biomarkers of infectionQPS540
Electrical dental anesthesia deviceLWM530
Dialysis holding tankFIN514
Apparatus, Cell-Freezing And ReagentsKSP530
Nuclear flood source phantomIYQ520
Animal and human seraKIS531
Air-conduction hearing aid softwareSCR550
Temporary tissue markerPBY520
Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory RateQME550
Attention task performance recorderLQD520
Prescription spectacle lenses to reduce the progression of myopiaQUR520
X-ray collimatorEHB420
Subungual hematoma battery powered drillNWF440
Laryngeal-bronchial telescopeENZ420
Intraluminal artery stripperDWX420
Plate, Fixation, Bone, Non-Spinal, MetallicNDF431
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Trunnion-BearingLGE431
Prosthesis, Hip, Semi-Constrained, Metal/Metal, ResurfacingNXT423
Toynbee diagnostic tubeETK430
Battery-powered corneal burrHOG440
Shunt system implantation stainless steel instrumentPIY420
Eustachian bougieKBI430
Paracervical anesthesia setHEE421
Removable metallic covered pancreatic stentPCU431
Slit-scanning ophthalmic cameraQER430
Magnetic locatorFTZ420
Endoscopic rigid telescopeFBP420
Rechargeable battery boxFCO420
Dilator, Esophageal (Metal Olive) Gastro-UrologyEZM430
Catheter tip occluderDQT413
AC-powered operating headlampHPQ410
Multi-lumen hemodialysis catheterization kitPPO431
Iron colorimetry bathophenanthroline (non-heme)CFM420
Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu AdmissionPTF421
Cardiopulmonary bypass bubble detectorKRL432
Manual antimicrobial susceptibility test systemsJWY4322
Gram positive identification panelLQL426
Infant pulse rate and oxygen saturation monitor for over-the-counter useQYU430
Fontanna silver solutionHYE410
Alkaline phosphataseJCJ430
EchocardiographDXK420
Endoscopic suturing device for altering gastric anatomy for weight lossQTD430
Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ ProlapsePWI432
Temporarily implanted peripheral nerve stimulation system for sustained pain reliefSCN420
Device, Incontinence, Mechanical/HydraulicEZY415
Analyzer, Gas, Water Vapor, Gaseous-PhaseBXA430
Facility use noninvasive positive airway pressure systemSGR430
Dental sonography device for monitoring jaw soundsNFQ420
Karaya denture adhesiveKOP440
Endodontic silver pointEKL430
Graft, Vascular, Synthetic/Biologic CompositeMAL437
Endoscope transformerGCW432
Collagen surgical mesh containing drugsPIJ410
Diaphragmatic hernia collagen surgical meshOWV411
Kidney perfusion kitPIN430
Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/ScoringNWX433
Differential gas pressure transducerBYR430
Test kit for bloodborne pathogen (donors)MYZ410
Powder-free polychloroprene patient examination gloveOPC420
Fiberoptic nonmetal vaginal speculumHIC430
Intraoperative soft tissue trackingOEW431
Radioassay, Intrinsic Factor Blocking AntibodyLIG423
Saccharomyces cerevisiae antibodies (s.cerevisiae)NBT420
Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii AntibodyNYO430
Factor Xiii A, S, Antigen, Antiserum, ControlDBT430
Gastroenterology-urology accessories to a biopsy instrumentQFZ430
Biliary catheter for irrigation and contrast injection (exempt)PTT430
Implantable sensor driven single chamber pulse-generatorLWO420
Neurosurgical laser with mr thermographyONO421
Securement wound dressing for reduction of infectionSEL410
Catheter, Urological (Antimicrobial) And AccessoriesMJC4412
Implantable post-surgical kinematic measurement knee deviceQPP411
Inflatable penis prosthesisJCW428
Ammonia photometric methodJID411
Tobramycin enzymatic radiochemical assayLDO410
SARS-COV-2 serology testQVP430
Respiratory syncytial virus - elisaMCE420
Antisera, Cf, Influenza Virus A, B, CGNW421
IGG immunoassay reagentKTO442
Low-vision hand-held telescopeHKB430
Hemoglobin A2 quantitationJPD434
Injection data capture deviceQOG430
Implanted Mechanical/Hydraulic Urinary Continence Device Surgical AccessoriesQGD420
Shigella spp. antisera of all typesGNB432
H. influenza antisera of all typesGRP421
Invasive bone growth stimulatorLOE412
Color scannerKZN440
Brachial plexus anesthesia kitOGA420
Antisera, Fluorescent, All Globulins, Salmonella Spp.GOO420
Methamphetamine high pressure liquid chromatographyLAG410
Barbiturate radioimmunoassayDKN410
Amphetamine liquid chromatographyDNI410
Nonabsorbable expanded polytetrafluoroethylene surgical suture for chordae tendinae repair or replacementPAW431
System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct SpecimenPOC420
Test, Factor Ii G20210a Mutations, Genomic Dna PcrNPR412
Test, Factor V Leiden Mutations, Genomic Dna PcrNPQ419
DNA-based test for minimal residual disease for hematologic malignanciesQDC410
Tumor marker test system for detection of bladder cancerNAH410
System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, ColonyPMY420
Angiotensin converting enzyme radioassayKQN440
Radiation therapy simulation systemKPQ429
Battery-powered stereoscopeHJR430
System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis TreatmentPFV421
Prosthesis, Posterior Spinal ElementsQWK421
Endocervical aspiratorHFC410
Pulmonary stentQWC410
Interactive wound and burn dressingMGR417
Non-sterile ENT piston cutting jigNNO440
Research Use Only/Hematology DevicesOTQ430
Immunochemical, CeruloplasminCHN422
Automated cervical cytology slide readerMNM411
Tympanometer (exempt)PTP440
OrceinKKF420
Chelating agent for decalcificationKDY430
Sirius redHZY420
Absorbable implant (scleral buckling methods)HQJ420
Anaerobic transport culture mediaJSL440
Pharmacy-filled drug specific infusion pumpQJY410
DistometerHMM440
Internal hinged elbow fixatorOZI410
Prosthesis, Finger, Semi-Constrained, Metal/PolymerSFA420
Regional anesthesia kitOFV440
Cytology kitOKY430
Balloon gastrostomy tube kitPRP440
Forensic evidence sexual assault kitOHE420
Lumbar drainage catheter kitPVO430
Obstetrical vacuum delivery kitOHC430
Transtibial anterior cruciate ligament kitPPQ440
Thoracic catheter insertion trayPYI421
Single needle with uni-directional pump kitPPH430
Laparoscopic bone anchor urethropexy instrument kitNWN421
Suprapubic catheter accessoriesQGC430
Vascular access flush heparinNZW4111
Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain ReliefMZW433
Mycobacterium tuberculosis complex nucleic acid amplification systemMWA412
Hepatitis C virus genotyping assayOBF420
System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) AssaysNTH420
Potassium colorimetry tetraphenyl borateCEJ420
Line isolation monitorDRI431
Muller's colloidal ironHZD410
At home intravaginal insemination systemQYZ410
High intensity ultrasound system for prostate tissue ablationPLP441
Peritoneal shuntKPM410
Polymer plug subtalar prosthesisMJW420
Control antisera for nontreponemal testsGMP410
Systemic lupus erythematosus test systemDHC411
Cryptococcus elisa antigenMDU421
Antisera, Latex Agglutination, Cryptococcus NeoformansGMD423
Coccidioides immitis enzyme linked immunosorbent assayMIY410
Malecot catheterFEW420
Emergency airway needleBWC432
Over the counter denture cushionEHS430
Endodontic stabilizing splintELS440
Peripheral temporary and retrievable stent systemSEU420
Control antiserum antigen igdCZJ420
Iga, Fitc, Antigen, Antiserum, ControlCZN430
Transcatheter septal occluder (atrial)OZG430
Mixture, Control, White-Cell And Red-Cell IndicesGLQ420
Blood collection device for cell-free nucleic acidQMA410
Platelet controlGJP430
HemoglobinometerGIG420
Automatic pneumoperitoneum apparatusFDP410
Ankle fusion cageSAI420
Spot-film deviceIXL432
Neisseria gonorrhoeae identification kitJSX421
Hematology quantitative pipetteGJG430
Illuminator system for blood productsPJF420
Non-bronchoscopic bronchoalveolar lavage catheterOYI430
Antimicrobial susceptibility test panelsLTT428
Gram negative identification panelLQM422
Laparoscopic power morcellation containment system with instrument portPMU431
Mycoplasma spp. all cf antigensGSB420
Norovirus serological reagentOUC420
Fibrin sealant preparation deviceMZM420
Coated implanted hemodialysis catheterNYU433
Endoscopic magnetic retriever (exempt)PTQ420
Automated breast ultrasoundPAA421
Image acquisition and/or optimization guided by artificial intelligenceQJU440
Barrier Face Covering Within The Scope Of The Face Mask And Barrier Face Covering Enforcement PolicyQOZ420
Room air handling apparatusFZH420
Ammoniacal silver hydroxide silver nitrateICZ410
Liquid high level disinfection reprocessing instrument for ultrasonic transducersPSW410
Formalin-sodium acetate solutionIGB410
2 herpesvirus hominis 1 fluorescent antiseraGQL410
Echinococcus spp. positive control antiseraGPE420
Mycobacterium tuberculosis cell mediated immunity testNCD422
Fta-abs test anti-human globulinGMS410
Cytomegalovirus cf antigen (including cf control)GQH411
Oral fluid drugs of abuse and alcohol test specimen collection devicePJD410
Control antiserum antigen lipoprotein XDEL430
Anaerobic transport systemsJTX420
Finger semi-constrained pyrolytic carbon uncemented prosthesisNEG412
High Demand, Revision, Semi-Constrained, Pyrolytic Carbon, Uncemented Finger ProsthesisOMX410
Ophthalmic rotary prismHKQ430
A-V shunt accessoriesKNZ420
Intracranial coil-assist stentQCA432
Flow cytometric test system for hematopoietic neoplasmsPWD430
PneumotachometerJAX431
Non-electric cystometric table and accessoriesKQS420
Test reagents for ethyl alcoholDMJ410
Methotrexate enzyme immunoassayLAO422
Mesh, Surgical, Absorbable, Plastic And Reconstructive SurgeryOXF420
Insulin suspend interoperable automated glycemic controllerQJS410
Laser assisted lipolysisORK420
Lidocaine enzyme immunoassayKLR421
Endometrial brushHFE411
Manual platelet countingGLG420
Red-cell diluting fluidGJN410
Blow bottleBYO420
Instrument for auto reader & interpretation of overnight suscept. systemsLRG415
Acid, Delta-Aminolevulinic, Ion-Exchange Columns With ColorimetryJKL430
Ultraviolet detectorEAQ420
Diphenylhydantoin fluorescence polarization immunoassay (total)LGR430
Antigen(Complexed), Prostate Specific, (Cpsa)NAF410
Gastrin radioimmunoassayCGC431
Endocapsular ringMRJ430
Accommodative intraocular lensNAA411
Filler, Bone Void, Calcium Compound Containing Single Approved AminoglycosideQRR430
Cell culture spinner systemKJE420
Electrophoretic Separation, LipoproteinsJHO420
Endoscopic light-projecting measuring deviceQTH410
Comparison Of Freezing Points & Stds. Of Known Osmotic Pressure, OsmolalityJMZ430
Carbon-monoxide gas chromatographJKT420
Acid hematinGGF420
Material, External Aesthetic Restoration, Used With AdhesiveGBI440
Test, Epithelial Ovarian Tumor Associated Antigen (He4)OIU420
Alzheimer’s disease pathology assessment testQSE430
Rhinoanemometer (measurement of nasal decongestion)BXQ440
Auditory impedance tester (exempt)PTO440
Phakic intraocular lensMTA432
Urinary methylmalonic acid test systemLPT431
Brucella spp. fluorescent antiseraGSM422
Radiation therapy marking deviceQRN410
Portable liquid-oxygen unitBYJ423
5-Amp-Phosphate Release (Colorimetric Test), 5'-NucleotidaseCED430
Cosmetic use static electricity-emitting deviceNZF420
Lactate dehydrogenase tetrazolium int dye-diaphoraseCFH430
Peritoneal dialysate warmerMLW420
Root canal irrigation air-powered handpieceNYL420
Semi-Constrained Metal/Polymer Finger Joint ProsthesisMPK411
Prosthesis, Finger, Constrained, Metal/PolymerKWG420
Colorimetric Method, LipoproteinsJHM433
OscillometerDRZ430
Patient vaginal lubricantMMS412
Surgical camera lensFXQ430
Ovarian adnexal mass assessment score test systemONX420
Epstein-barr virus cf antiserumGNP412
Tissue adhesive for use in embolization of brain arteriovenous malformationsKGG421
Synthetic peptide bone void fillerNOX414
Deformability cytometry for sepsis risk assessmentQUT410
Battery-powered keratoscopeHLR440
Accessory - film dosimetry systemMWW430
Powered light based non-laser surgical instrumentONE440
Assembly, Shoulder/Elbow/Forearm/Wrist/Hand, PoweredKFW440
Pulmonary valveNJK413
Ophthalmic needleQYM440
Immunoassay blood test for amyloid pathology assessmentSET441
Medical ultraviolet water purifierKMG430
Water purification subsystem disinfectantNIH410
Dialysis arm clampNOO420
Respiratory accessory microbial reduction device.QXQ421
Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass SpectrometryQQV430
Culture plate imaging system for qualitative assessment of resistant organismsQQY440
Osmolality of tearsOND420
Insufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, BipolarPGT420
Mesh, Surgical, Polymeric, Resorbable, Orthopedics, Reinforcement Of LigamentQWJ410
Ophthalmic prism readerHJX430
Jenner stainKJX410
Lynch syndrome test systemPZJ430
Electrosurgical, Cutting & Coagulation & Accessories, For Cardiac Electrophysiology Device Implantation And RevisionSFQ420
Automated cryopreservation storage systemQUJ420
Non-sterile label or tagQMX420
Capsule gastrointestinal motility systemNYV430
Ophthalmic bar readerHJY430
PhotorefractorMMF420
Capsular tension ring injectorNCE430
Non-niosh-approved disposable filtering facepiece respirators (FFRS)QKU410
Cranial electrotherapy stimulator to treat depressionJXK433
Pulmonary hypertension machine learning-based notification softwareSAT410
Artificial eye iris buttonNCK430
X-ray angiographic imaging based coronary vascular simulation software deviceQHA420
Therapeutic flotation cushionMOC430
Implanted tibial electrical urinary continence deviceQXM440
HIV self-testsQSS420
Ingested, Transient, Space Occupying Device For Weight Management And/Or Weight LossQFQ440
Ultraviolet radiation disinfection chamber deviceSCS420
Automated slide spinnerGKJ441
Ventilator-compatible nebulizerSFP420
High intensity focused ultrasound system for peripheral neural tissue ablationSGN430
Transcutaneous nerve stimulator for adhdQGL430
Semi-automated mixing and weighing deviceMYJ430
Battery-powered optical vision aidHPE420
Ventilatory electrical impedance tomographQEB430
Dental navigation systemQRY422
Powered dental muscle stimulatorNUW430
Irradiator, Blood To Prevent Graft Versus Host DiseaseMOT442
Electromechanical arm for a transcranial magnetic stimulation systemQFF430
Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep ApneaQNO440
Defibrillator testerDRL421
Digital amsler gridQTW430
Amnioscope, Transabdominal (Fetoscope) (And Accessories)HFA310
Fetal blood sampling endoscope (and accessories)HGK310
Eyepiece attachment for insertion of prescription lensFDZ320
Prosthesis, Hip, Semi-Constrained, Composite/MetalKMC321
Temporarily-placed urethral opening system for symptoms of benign prostatic hyperplasiaQKA320
Adult negative pressure external body ventilator (cuirass)BYT330
Mastoid searcherJZC330
Manual algesimeterBXL330
Wire claspEJW330
TracheotomeLJW331
Instrument, Clip Forming/CuttingHBS320
Ether hookBTB310
In-line retrograde flow cpb check valveMJJ322
Dual lumen ecmo cannulaPZS320
Tongue suspension systemORY320
Intravascular catheter optical coherence tomographyORD310
Antisera, Cf, Equine Encephalitis Virus, Eee, WeeGQC320
Reprocessed catheter introducerPNE310
Nose and throat ear cementNEA310
Laparoscopic contraceptive tubal occlusion deviceKNH334
Implantable transprostatic tissue retractor systemPEW332
Pulmonary surgery neodymium:yag laserLLO320
Endoscopic sponge carrierFGS321
Rigid bronchoscope aspirating tubeKTR320
Vitamin assay culture mediaJSB320
ENT surgical saw (electric or pneumatic)EWQ330
Trocar kitOKX330
Anaerobic identification kitJSP322
System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured IsolatesPEX321
Enterobacteriaceae identification kitJSS329
Hyperoxia monitoring device adjunct to pulse oximetryQWE330
Eosin BICC320
Leukocyte peroxidase testGIA310
Temporary coronary saphenous vein bypass graft for embolic protectionNFA322
Bronchoscope biopsy forceps (non-rigid)BWH320
Device, Impotence, Mechanical/HydraulicFHW314
Radial immunodiffusion plates and equipmentJZQ321
Testicular prosthesisFAF321
Direct patient interface spacerNVO320
Diluting pipetteGGY320
Venous arterialization infrapopliteal stent graftQWN330
Ocular pegMQU331
Arch tracing inkKZO330
Adhesive, Denture, Karaya And Ethylene-Oxide HomopolymerKXX320
Gingival fluid measurerJEO330
Hybrid Stent Graft, Thoracic Aortic Lesion TreatmentQSK320
Absorbable infrapopliteal scaffoldNXW310
Biliary stent system for benign stricturesPNB320
Stent, Urethral, Prostatic, Permanent Or Semi-PermanentMER320
Central venous stentQKJ330
Spatial imaging for display of endoscope positionPGU310
Nuclear scanning bedIYZ320
Breathing assist rocking bedCCO330
Heavy metals control materialsDIE320
Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented Or Uncemented ProsthesisQKW310
Sp100 nuclear body protein autoantibodiesNUM320
Anti-ss-a 52 autoantibodiesOBE320
Autoantibodies, Nuclear Pore Glycoprotein Gp210NRI320
Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1)NBS320
Autoimmune hepatitis anti-soluble liver antigen autoantibodies (SLA)NIY320
Protamine sulphateGFT310
Pedicle screw placement guidePQC320
Posterior cervical screw placement guideQSD320
Corneal electrodeHLZ320
Reprocessed high-density intracardiac mapping catheterNLG310
Vaginal stentKXP320
Percutaneous catheter for creation of an arteriovenous fistula for hemodialysis accessPQK321
Immunoassay for detection of amniotic fluid protein(s).NQM313
Mechanical and enzymatic autologous skin processor for cell suspension with applicatorQCZ310
AC-powered nerve stimulatorBXM310
Separator For Therapeutic Purposes, Membrane Automated Blood Cell/PlasmaMDP322
Amylase starch-dye bound polymerCIW322
C. diphtheriae fluorescent antiserumGOS320
Capsid EBV antigenMCD320
Immunochemical, Lysozyme (Muramidase)JMR330
Q fever cf antiserumGPR320
Acid, Nitrous And Nitrosonaphthol, 5-Hydroxyindole Acetic Acid/SerotoninCDA321
Adenovirus 1-33 fluorescent antiseraGNY320
Pregnenolone radioimmunoassayJNG330
Antibody detection Candida speciesLSG330
Absorbable collagen hemostatic agent with thrombinPMX322
Subperiosteal implantELE320
Vaginal insufflatorHEC330
Port & Catheter, Implanted, Subcutaneous, IntraventricularLKG320
External cerebrospinal fluid (CSF) diversionPCB331
Manual blood grouping and antibody test systemsPBC330
Hemodialysis system for home useONW322
Insulin autoantibody kitOCN330
Antisera, All Types, Listeria MonocytogenesGSH320
B. parapertussis agglutinating antiseraGOW310
Larynx prosthesis (stents and keels)FWN311
Permanent implant keratoprosthesisHQM310
Vascular embolization agentQVG310
Antimicrobial drapesPLY310
Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To TransplantationQBA320
Gastric irrigation and aspiration kitPRT320
Uterine elevatorHDP330
Myoglobin, Fitc, Antigen, Antiserum, ControlDEA310
Influenza virus nucleic acid amplification direct assayNIA310
Simple point-of-care nucleic acid-based hepatitis C virus ribonucleic acid testSBP320
System, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct SpecimenPEU311
Multiplex nucleic acid detection system for biothreat agentsQVR310
Sterile irrigation trayEYN323
Pacemaker polymeric mesh bagDSW320
Mesh, Surgical, Absorbable, Thoracic, Chest Wall ReconstructionOWZ310
Orthopedic computer controlled surgical systemOJP310
Aortic stentPNF310
Cement removal extraction systemLZV320
Non-sterile prosthesis modification instrument for ossicular replacement surgeryNNS320
Fibrinogen control plasmaGIL320
Carbohydrate deficient transferrin testNAO332
Apixaban anti-factor xa activity test systemQLU321
Ponceau stainHZO330
Erythrosin BKJR330
Ophthalmic neodymium:yag laser for posterior capsulotomy and cutting pupillaLXS321
Hepatitis B antigen identification systemKSJ320
Corneal inlay inserter handleQGJ320
Implanted brain stimulator for behavior modificationMFR310
Rib replacement prosthesisMDI321
Graft insertion instrument for endothelial keratoplastyOTZ310
Powered external limb component wrist unitKGH330
In situ polymerizing peripheral nerve repair deviceSFD311
Biological tissue ophthalmic conformerNQB321
Analyzer, Gas, Helium, Gaseous-PhaseBSE330
Analyzer, Gas, Nitrogen, Gaseous-PhaseCCI330
Perineal irrigation kitPSI330
Admission kit (patient utensil)PWM320
Hemodialysis Tray (Not A Start/Stop Kit)PPI320
Nephroscope setPPE330
Body fluid disposal kitOKF320
Discography kitOIL320
Wound drainage kitPYL330
Peritoneal dialysis administration kitPPJ320
Staple removal kitPYE330
Burn dressing trayPXQ320
Restorative instrument and component trayOFW330
Suprapubic cystostomy catheter kitNWP320
Surgical cannulaes & depth gauge kit for arthroscopic proceduresPPR321
Vaginal examination trayPVX331
Automated heparin analyzerJOX312
Automated clot timerGKN310
MercuryELY330
System, Test, Her-2/Neu, Nucleic Acid Or SerumMVD330
Finger-sucking deviceLQX320
Wound dressings containing topical analgesicsSEJ310
Posterior ratcheting rod systemQGP330
Alpha-L-iduronidase (IDUA) newborn screening test systemPQT330
Alpha-D-glucosidase (GAA) newborn screening test systemPQU330
SS-glucocerebrosidase (GBA) newborn screening test systemPQV330
Alpha-D-galactosidase a (GLA) newborn screening test systemPQW330
Venipuncture kitPXL330
Battery-powered instruments charged through sterile barriersSAM330
Test, Donor, Syphilis, Antigens, TreponemalMYR330
Pneumocystis cariniiLYF310
Qualitative cytomegalovirus nucleic acid-based detection device for congenital cytomegalovirus infectionQDZ310
Prosthesis, Eyelid Spacer/Graft, BiologicNXM310
Ablation System, High Intensity Focus Ultrasound (Hifu), Soft TissuePZC310
Resin denture hydrophilic coatingEBE330
Subcutaneous implanted apheresis portPTD320
Vessel dilatorFKA320
Vein stabilization deviceLBJ321
Lambda, Fitc, Antigen, Antiserum, ControlDES330
Control antiserum antigen complement C5DAY320
Igg, Fitc, Antigen, Antiserum, ControlDGK331
Igm, Fitc, Antigen, Antiserum, ControlDFS330
Kappa, Fitc, Antigen, Antiserum, ControlDEO330
Battery-powered spectacle dissociation test (lancaster)HLO320
Dental amalgamOIV330
Transdermal test for assessment of glomerular filtration rateSDK310
Light based device for dry age-related macular degenerationSDE321
Protein calorie malnutrition adjunct monitorQJB320
Antimicrobial susceptibility test cardsLTW319
Powered reflex hammerIKO330
Urea nitrogen conductivity rateLFP320
Calcium titrimetric with edta and indicatorCHW320
Vitamin E fluorescence hexane extractionJOB320
L-Leucine-4-Nitroanilide (Colorimetric), Leucine ArylamidaseJGG320
Fluorescent immunoassay gentamicinLCQ322
Switching valve (ploss)JFE320
Powered patient transportILK334
Blood detection capsuleQUD320
2nd antibody sep. goat antibody digoxin radioimmunoassay (3-H)DOY320
Selective and differential gbs culture mediaPQZ323
Plaque morphology evaluation intravascular catheterOGZ321
Steerable catheter control systemDXX324
Instrument, Vitreous Aspiration And Cutting, Battery-PoweredHKP310
Nasal airway balloonQGK320
Trichomonas vaginalis DNA probeMJK325
Antigens (Febrile), Agglutination, Brucella Spp.GSO311
Fetal fibronectin enzyme immunoassayLKV312
Dengue nucleic acid amplification assay (NAAT)OZB310
Gynecologic power morcellator and containment systemSIM330
Esophageal sizing laparoscopic accessoriesQJN320
COVID-19 test home collection kit devicesQLW321
Not assay specific internal polymerase chain reaction controlOLD310
Typhus fever antiserumGPN311
Parvovirus B19 IGM enzyme linked immunosorbent assayMYM321
Parvovirus B19 IGG enzyme linked immunosorbent assayMYL322
Upper Extremity Prosthesis With Multiple Simultaneous Degrees Of Freedom And Controlled Via Cutaneous ElectromyographyPAE310
Aortic annuloplasty ringPST320
Hygroscopic-laminaria cervical dilatorHDY330
Parainfluenza virus 1-4 cf antigens (including cf control)GQS320
Central venous catheter with manual insertion systemSEF330
Antiserum, Positive And Negative Febrile Antigen Control SerumGSN311
Vaginal hydrogel packing systemQXR320
Albumin-based adhesiveKEL310
Metanil yellowHYY310
Toxoplasma gondii if antigensGLZ310
Bacterial sialidase vaginal testMXB321
Treponemal syphilis testMTN311
Thin Layer Chromatography, Tricyclic Antidepressant DrugsMLK310
Epstein-barr virus fluorescent antiserumJRY310
Lab-based HIV nat diagnostic and/or supplemental testQST310
Substance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic UseKSX310
Albumin, Rhodamine, Antigen, Antiserum, ControlDFJ320
Control antigen indirect immunofluorescent antismooth muscle antibodyDBE310
Gynecologic surgical laserHHR330
Interosseous needleMHC320
Manual perimeterHON320
Opticokinetic drumHOW330
Salivary cortisol enzyme immunoassayNHG323
Measuring device for panendoscopeFDY320
Reverse central venous recanalization systemQJH320
Cardiopulmonary bypass cardiotomy suction line blood filterJOD320
Material, Dressing, Surgical, Polylactic AcidLPG311
Treponema Pallidum ha antigensGMT330
Lubricating jelly for transurethral surgical instrumentFHX320
Single patient dialysate delivery systemFKP317
External facial fracture applianceFYI330
Software controlled endoscope and instrument holderQZB330
Enzymatic method sodium test systemMZU310
Uterine suction cannulaHGH330
All mycoplasma spp. antiseraGSA330
Fluorescence imaging for breast cancer detectionSAW311
Endoscopic traction deviceQSW320
Amikacin radioimmunoassayKLQ320
Ornithine carbamyl transferase nessler arsenate citrulline (colorimetry)JMY310
Solution, Orth'SIFN310
A-V shunt cannulaFIQ320
Respiratory humidifier for emergency useQOP330
System, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular Diagnostic TestNTW331
Dermatophyte identification kitJSR330
System, Test, Her-2/Neu, MonitoringNCW311
Hematology general purpose deviceLOQ321
Circumcision bellFHG320
Manual colony counterKZC330
Implanted phrenic nerve stimulator for central sleep apneaPSR320
Stimulator, Neuromuscular, Lower Back Muscles, Totally Implanted For Pain ReliefQLK320
Platelet aggregation reagentGHR321
Fluorometric Measurement, PorphyrinsJKJ320
Platelet aggregrometerJBX320
EvaporatorJRK310
Hemorrhoid prevention pressure wedgeOOA320
Sudan IVKKK312
Phloxine BHZL320
Neonatal phototherapy blanketPDH321
Chromogranin aQXS330
Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast CancerNYI321
Chromatography (Liquid, Gel), Clinical UseKZR320
Q fever cf antigenGPS320
Blood borne pathogen response kitPWP310
Burn kit with drugOJI320
Cardiopulmonary bypass gas control unitDTX330
Amikacin serum assayKLP320
Disodium phenylphosphate acid phosphataseCJX320
OxyhemoglobinGGZ320
Phenobarbital fluorescence polarization immunoassayLGQ322
Diphenylhydantoin fluorescence polarization immunoassay (FREE)MOJ320
Carbamazepine fluorescence polarization immunoassayLGI321
Intra-articular orthopedic stereotaxic navigation instrumentSIQ310
Facility use apnea monitorFLS312
Manual instruments designed for use with non-fusion spinous process spacer devicesQLR321
Roller type cardiopulmonary bypass blood pumpDWB322
Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230OEG320
B 1-6 coxsackievirus a 1-24 fluorescent antiseraGNM320
Adenovirus 1-33 cf antiseraGOA320
Esophagoscope for general and plastic surgeryGCL320
Galectin-3 in vitro diagnostic assayOSX320
Enzymatic (Glutathione Reductase), GlutathioneJLO320
25-oh-vitamin D mass spectrometry test systemPSL330
N-Acetyl-L-Tyrosine Ethyl Ester (U.V.), ChymotrypsinJKW320
Lipoprotein test system (A)MSM320
Transparent patch for use in treatment of tattoosPKO310
Dermal implant for aesthetic use in the handsPKY320
ParallelometerEGI320
Ocular pressure applicatorLCC310
Mechanical treadmillIOG320
Programmed death-ligand 1 antibody immunohistochemistry assayPLS312
Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein AssayQNH310
Reprocessed gynecologic laparoscope and accessoriesNMH320
Ifa antibody antigen respiratory syncytial virusLKT310
Electrolytic decalcifier deviceKDZ330
Dialysis solution-test standard-conductivityFKH322
Thymolphthale inmonophosphate acid phosphataseCKE320
Glucose-6-Phosphate Dehydrogenase (Erythrocytic), QuantitativeJBL321
Radioimmunoassay, Cholyglycine, Bile AcidsKWW320
Contraceptive diaphragm (and accessories)HDW323
Alpha-Naphthyl Phosphate, Alkaline Phosphatase Or IsoenzymesCJO321
Contact cooling for skin lesion pain reliefQPZ320
Ophthalmic battery-powered electrolysis unitHPY330
Psittacosis cf antigen (chlamydia group)GPW310
Dual-chamber implantable defibrillatorMRM337
Chromosome culture kitKIQ310
AC-powered optical vision aidHPI330
Electrosurgical coagulation for aestheticONQ330
Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-PoweredPUL320
Powered insertion system for a cochlear implant electrode arrayQQH321
Drug metabolizing enzyme genotyping systemsNTI323
Single lumen ecmo cannulaQHW320
Cardiopulmonary bypass coronary pressure gaugeDXS313
Percutaneously delivered prostheses and tricuspid valvesNPW321
Permanent vascular occluding agentPJQ322
Nuclear anthropomorphic phantomIYP310
Flexible endoscopeGCQ311
Prognostic test for development or progression of preeclampsiaQWH321
Control Material, Blood Circulating Epithelial Cancer CellNRS311
Micro total analysis instrument systemOUE311
Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular CarcinomaOAU310
Ophthalmic tantalum clipHQW320
Right ventricular bypass (assist) deviceOJE320
HIV-1 test monitorMTL311
Gastrointestinal bacterial panel multiplex nucleic acid-based assay systemPCI320
Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient SettingsQWR312
Pectoralis muscle implantMIC311
Laser activator for polymerizationQNF330
Battery-powered keratomeHMY312
Candida species nucleic acid detection systemPII311
Dermal replacement deviceMDD313
Operator intervention image analysis automated microscopeNOT322
Adjunctive pain measurement device for anesthesiologyQVE320
Epinephrine syringePQX310
Gynecological fibroid screwHHO320
Mechanical-powered jet injectorEGM330
Orthodontic vibratory accessoryOYH320
Intraoral cooling deviceQUA320
Droplet digital PCR systemPHG330
Hydrazone Colorimetry, Ast/SgotCIS330
Lithium atomic absorptionJII320
Quality control for molecular immunohematology testsPFK320
Hyperthermia monitorNZE311
Intraoperative surgical angle measurement toolQWL320
AnomaloscopeHIW330
Densitometeric, Protein FractionationJQJ330
Implantable pulse generatorQFV331
Multivariate vital signs indexPLB320
Adjunctive cardiovascular status indicatorPPW320
Adenovirus 1-33 ha antigens (including ha control)GOB320
Fetal hemoglobin stainGHQ311
Hypodermic single lumen low dead space needleQNS330
Prosthesis, Tracheal, Preformed/MoldedNWA320
Wound autofluorescence imaging deviceQCR320
System, Test, Genotypic Detection, Resistant Markers, Staphylococcus ColoniesMYI320
Robotic diagnostic ultrasonic transducerOQQ330
Mr-guided focused ultrasound systemPOH310
Test, Nitrite, Urinary, Non-Quantitative, Over The CounterNGJ321
Enumeration circulating cancer cell immunomagnetic systemNQI318
5-anhydroglucitol 1 assay (15ag)NOZ320
Sterilizer automated loading systemPEC330
HDL cholesterol via esterase-oxidase electrophoresisLBT330
Phakic toric intraocular lensQCB322
Microbial colony image assessment systemPPU320
Wearable vibration device for orthopedic useQZO320
Surgical Mask With Antimicrobial/Antiviral AgentOUK330
Intraocular pressure lowering knifeQUQ310
MagnetoencephalographOLY330
Light based imagingPSN320
2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And IdentificationOQW330
Vagus nerve stimulator for rheumatoid arthritisSFJ320
Electromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile FieldSDD310
Device to detect antigens of biothreat microbial agents in human clinical specimensQID310
Abnormal breath sound devicePHZ330
Computerized behavioral therapy device for insomniaQVO330
Dialysis temperature monitorFLA330
Over-the-counter impression material for fabrication of patient-matched mouthguardsSHI310
Poly nonabsorbable surgical suture (vinylidene fluoride)MXW320
Vibrator for climax control of premature ejaculationPIA320
Temperature discrimination testLQW320
Minimal ventilatory support continuous ventilatorQOR310
Cardiovascular machine learning-based notification softwareQXO320
Photoplethysmograph analysis software for over-the-counter useQDB320
Low power electrosurgical devices for skin lesion destructionQVJ330
Magnetically maneuvered capsule endoscopy systemQKZ320
Blood culture microorganism identification mass spectrometryQNJ320
Intense pulsed light device for managing dry eyeQIU320
Enclosure air handling apparatusFZI320
Mist high level disinfection reprocessing instrument for ultrasonic transducersOUJ321
Electrogastrography system (EGG)MYE320
Rt-qpcr assay for mrna transcript immune biomarkersPRE320
Nitric oxide generator and delivery systemQTB320
Infant supine sleep systemQTG322
Pediatric hemodialysis systemQIR310
Hypothermic machine perfusion system and accessories for orthotopic liver transplantSGY320
Sub-scalp implanted electroencephalogram system for remote patient monitoringSEM310
Direct contact perineal heaterHGZ320
Plasma viscometer for clinical useJJL320
Breast lesion documentation systemNKA320
Coronary vascular physiologic simulation softwarePJA320
Bed-patient activity monitoring systemSBO310
Infant position holderFRP310
Percutaneous catheter (valvuloplasty)MAD320
Orthodontic LED accessoryPLH330
Assisted reproduction embryo image assessment systemPBH330
Nerve stimulator for restless legs syndromeQWD330
Uncompensated thorpe tubeBYM320
External mechanical stimulator for the relief of congestionQZC330
Cranial measurement softwareQQO320
Over-the-counter molecular test to detect SARS-COV-2 from clinical specimensQWB321
Brain injury adjunctive interpretive oculomotor assessment aidQEA312
Paraffin bathIMC320
Software for visualization of vascular anatomy and intravascular devicesPZO330
Adjunctive cardiac amyloidosis status indicatorSDJ330
Computerized cognitive assessment aid for concussionPOM310
Medicinal leechesNRN330
Adjunctive heart failure status indicatorQUO320
Intranasal expiratory resistance valve for obstructive sleep apneaOHP312
Impedance measuring device utilizing oscillation techniquesPNV330
Coronary artery disease risk indicator from acoustic heart signalsQMW320
Computerized cognitive assessment aidPKQ320
Transcutaneous electrical spine stimulator to improve skeletal muscle strength and sensationSDO330
Diabetic retinopathy detection devicePIB310
Computerized behavioral therapy device for depressive disorders.SAP310
Caries detection product with drug or biologicQJX320

CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. FDA registration lists an establishment with the FDA and is not an approval of it: a 510(k) clearance or a PMA approval is for one device. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.