Data / Medical devices / Hong Kong / CBR Enterprise Limited

CBR Enterprise Limited: FDA-registered device maker in Hong Kong, Hong Kong, 542 510(k) clearances and 4 PMA approvals

Name: CBR Enterprise Limited FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

CBR Enterprise Limited is registered with the FDA (registration 3013557562) in Hong Kong, Hong Kong. It lists 366 device types. The FDA files 542 510(k) clearances and 4 PMA approvals under its listings, the newest dated April 10, 2026. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3013557562
Address: 300 Des Voeux Road Central Suite A, 9/F., Wah Kit Commercial Centre, Hong Kong, Hong Kong, Hong Kong
Owner or operator: CBR Enterprise Limited (10054430)
Roles: Exporter to the US
First device listed: March 22, 2017
Registered through: 2027
Brand names listed: 3ml Syringe W/Dtchbl Needle 21G x 1 1/2", APPLICATOR, BAG, URINE COLLECTING, BAG, URINE COLLECTION, LEG,, BLOOD TRANSFER AND LUER LOCK ACCES, Bandage, liquid, skin protectant, CLEANING BRUSHES, FOR ENDOSCOPE, COLLECTOR, OSTOMY and more

Devices it lists

Device	Product code	Class	Role	Source
Absorbent, Carbon-Dioxide	CBL	1	Exporter to the US	accessdata.fda.gov
Absorber, Carbon-Dioxide	BSF	1	Exporter to the US	accessdata.fda.gov
Accessories, Blood Circuit, Hemodialysis	KOC	2	Exporter to the US	accessdata.fda.gov
Accessories, Cleaning Brushes, For Endoscope	MNL	1	Exporter to the US	accessdata.fda.gov
Accessory, Surgical Apparel	LYU	1	Exporter to the US	accessdata.fda.gov
Adaptor, Bulbs, Miscellaneous, For Endoscope	FFY	1	Exporter to the US	accessdata.fda.gov
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	DTL	2	Exporter to the US	accessdata.fda.gov
Aid, Transfer	IKX	1	Exporter to the US	accessdata.fda.gov
Airway, Oropharyngeal, Anesthesiology	CAE	1	Exporter to the US	accessdata.fda.gov
Alloy, Amalgam	EJJ	2	Exporter to the US	accessdata.fda.gov
Amniotome	HGE	1	Exporter to the US	accessdata.fda.gov
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	CCK	2	Exporter to the US	accessdata.fda.gov
Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)	NHO	2	Exporter to the US	accessdata.fda.gov
Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)	CBQ	2	Exporter to the US	accessdata.fda.gov
Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)	CBS	2	Exporter to the US	accessdata.fda.gov
Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)	NHQ	2	Exporter to the US	accessdata.fda.gov
Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)	CBR	2	Exporter to the US	accessdata.fda.gov
Analyzer, Gas, Oxygen, Gaseous-Phase	CCL	2	Exporter to the US	accessdata.fda.gov
Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)	NHP	2	Exporter to the US	accessdata.fda.gov
Anesthesia Conduction Kit	CAZ	2	Exporter to the US	accessdata.fda.gov
Anoscope And Accessories	FER	2	Exporter to the US	accessdata.fda.gov
Anti Fog Solution And Accessories, Endoscopy	OCT	2	Exporter to the US	accessdata.fda.gov
Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus	GQG	1	Exporter to the US	accessdata.fda.gov
Apparatus, Electrosurgical	HAM	2	Exporter to the US	accessdata.fda.gov
Apparatus, Exhaust, Surgical	FYD	2	Exporter to the US	accessdata.fda.gov
Apparatus, Suction, Operating-Room, Wall Vacuum Powered	GCX	2	Exporter to the US	accessdata.fda.gov
Apparatus, Suction, Single Patient Use, Portable, Nonpowered	GCY	1	Exporter to the US	accessdata.fda.gov
Applicator, Absorbent Tipped, Non-Sterile	KXF	1	Exporter to the US	accessdata.fda.gov
Applicator, Absorbent Tipped, Sterile	KXG	1	Exporter to the US	accessdata.fda.gov
Applicator, Ent Drug	LRD	1	Exporter to the US	accessdata.fda.gov
Applier, Surgical, Clip	GDO	1	Exporter to the US	accessdata.fda.gov
Arthroscope	HRX	2	Exporter to the US	accessdata.fda.gov
Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus	MZO	2	Exporter to the US	accessdata.fda.gov
Attachment, Breathing, Positive End Expiratory Pressure	BYE	2	Exporter to the US	accessdata.fda.gov
Audiometer	EWO	2	Exporter to the US	accessdata.fda.gov
Automated External Defibrillators (Non-Wearable)	MKJ	3	Exporter to the US	accessdata.fda.gov
Bag, Bile Collecting	EXF	2	Exporter to the US	accessdata.fda.gov
Bag, Ice	KYR	1	Exporter to the US	accessdata.fda.gov
Bag, Urinary, Ileostomy	EXH	1	Exporter to the US	accessdata.fda.gov
Bag, Urine Collecting, Ureterostomy	EXG	1	Exporter to the US	accessdata.fda.gov
Bag, Urine Collection, Leg, For External Use, Non-Sterile	NNW	1	Exporter to the US	accessdata.fda.gov
Bag, Urine Collection, Leg, For External Use, Sterile	FAQ	1	Exporter to the US	accessdata.fda.gov
Bag, Urine Collection, Newborn	FOC	2	Exporter to the US	accessdata.fda.gov
Bandage, Cast	ITG	1	Exporter to the US	accessdata.fda.gov
Bandage, Elastic	FQM	1	Exporter to the US	accessdata.fda.gov
Bandage, Liquid	KMF	1	Exporter to the US	accessdata.fda.gov
Bandage, Liquid, Skin Protectant	NEC	1	Exporter to the US	accessdata.fda.gov
Basin, Emesis	FNY	1	Exporter to the US	accessdata.fda.gov
Bedding, Disposable, Medical	KME	1	Exporter to the US	accessdata.fda.gov
Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection	GCA	2	Exporter to the US	accessdata.fda.gov
Bilirubin (Total And Unbound) In The Neonate Test System	MQM	1	Exporter to the US	accessdata.fda.gov
Biopsy Needle	FCG	2	Exporter to the US	accessdata.fda.gov
Blade, Saw, General & Plastic Surgery, Surgical	GFA	1	Exporter to the US	accessdata.fda.gov
Blade, Saw, Surgical, Cardiovascular	DWH	1	Exporter to the US	accessdata.fda.gov
Blade, Scalpel	GES	1	Exporter to the US	accessdata.fda.gov
Blood Pressure Cuff	DXQ	2	Exporter to the US	accessdata.fda.gov
Blood/Plasma Collection Device For Dna Testing	PJE	2	Exporter to the US	accessdata.fda.gov
Bottle, Collection And Trap, Breathing System (Uncalibrated)	CBC	2	Exporter to the US	accessdata.fda.gov
Bottle, Collection, Vacuum	KDQ	2	Exporter to the US	accessdata.fda.gov
Bronchoscope (Flexible Or Rigid)	EOQ	2	Exporter to the US	accessdata.fda.gov
Bronchoscope Accessory	KTI	2	Exporter to the US	accessdata.fda.gov
Brush, Scrub, Operating-Room	GEC	1	Exporter to the US	accessdata.fda.gov
Bur, Ear, Nose And Throat	EQJ	1	Exporter to the US	accessdata.fda.gov
Bur, Surgical, General & Plastic Surgery	GFF	1	Exporter to the US	accessdata.fda.gov
Cable, Electrode	IKD	2	Exporter to the US	accessdata.fda.gov
Cage, Knee	ITM	1	Exporter to the US	accessdata.fda.gov
Cannula, Manipulator/Injector, Uterine	LKF	2	Exporter to the US	accessdata.fda.gov
Cannula, Nasal, Oxygen	CAT	1	Exporter to the US	accessdata.fda.gov
Cannula, Ophthalmic	HMX	1	Exporter to the US	accessdata.fda.gov
Cannula, Surgical, General & Plastic Surgery	GEA	1	Exporter to the US	accessdata.fda.gov
Catheter And Tip, Suction	JOL	2	Exporter to the US	accessdata.fda.gov
Catheter, Continuous Flush	KRA	2	Exporter to the US	accessdata.fda.gov
Catheter, Coude	EZC	2	Exporter to the US	accessdata.fda.gov
Catheter, Hemodialysis, Implanted	MSD	2	Exporter to the US	accessdata.fda.gov
Catheter, Intravascular, Diagnostic	DQO	2	Exporter to the US	accessdata.fda.gov
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	LJS	2	Exporter to the US	accessdata.fda.gov
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	FOZ	2	Exporter to the US	accessdata.fda.gov
Catheter, Irrigation	GBX	1	Exporter to the US	accessdata.fda.gov
Catheter, Nephrostomy	LJE	U	Exporter to the US	accessdata.fda.gov
Catheter, Nephrostomy, General & Plastic Surgery	GBO	1	Exporter to the US	accessdata.fda.gov
Catheter, Percutaneous	DQY	2	Exporter to the US	accessdata.fda.gov
Catheter, Peritoneal	GBW	1	Exporter to the US	accessdata.fda.gov
Catheter, Retention Type, Balloon	EZL	2	Exporter to the US	accessdata.fda.gov
Catheter, Suprapubic (And Accessories)	KOB	2	Exporter to the US	accessdata.fda.gov
Catheter, Urethral	GBM	2	Exporter to the US	accessdata.fda.gov
Catheter, Urological	KOD	2	Exporter to the US	accessdata.fda.gov
Catheters, Suction, Tracheobronchial	BSY	1	Exporter to the US	accessdata.fda.gov
Cement, Stomal Appliance, Ostomy	EZR	1	Exporter to the US	accessdata.fda.gov
Chair, Dental, Without Operative Unit	NRU	1	Exporter to the US	accessdata.fda.gov
Circuit, Breathing (W Connector, Adaptor, Y Piece)	CAI	1	Exporter to the US	accessdata.fda.gov
Clamp, Umbilical	HFW	2	Exporter to the US	accessdata.fda.gov
Cleaner, Ultrasonic, Medical Instrument	FLG	1	Exporter to the US	accessdata.fda.gov
Clip, Implantable	FZP	2	Exporter to the US	accessdata.fda.gov
Clip, Scalp	HBO	2	Exporter to the US	accessdata.fda.gov
Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System	ONB	2	Exporter to the US	accessdata.fda.gov
Coagulator, Laparoscopic, Unipolar (And Accessories)	HFG	2	Exporter to the US	accessdata.fda.gov
Collector, Ostomy	EXB	1	Exporter to the US	accessdata.fda.gov
Collector, Urine, (And Accessories) For Indwelling Catheter	KNX	2	Exporter to the US	accessdata.fda.gov
Collector, Urine, Powered, Non Indwelling Catheter	NZU	1	Exporter to the US	accessdata.fda.gov
Computer, Diagnostic, Programmable	DQK	2	Exporter to the US	accessdata.fda.gov
Computer, Oxygen-Uptake	BZL	2	Exporter to the US	accessdata.fda.gov
Condenser, Heat And Moisture (Artificial Nose)	BYD	1	Exporter to the US	accessdata.fda.gov
Connector, Airway (Extension)	BZA	1	Exporter to the US	accessdata.fda.gov
Connector, Catheter	GCD	1	Exporter to the US	accessdata.fda.gov
Conserver, Oxygen	NFB	2	Exporter to the US	accessdata.fda.gov
Container, I.V.	KPE	2	Exporter to the US	accessdata.fda.gov
Container, Liquid Medication, Graduated	KYW	1	Exporter to the US	accessdata.fda.gov
Container, Sharps	MMK	2	Exporter to the US	accessdata.fda.gov
Container, Specimen Mailer And Storage, Non-Sterile	NNK	1	Exporter to the US	accessdata.fda.gov
Container, Specimen Mailer And Storage, Sterile	KDT	1	Exporter to the US	accessdata.fda.gov
Container, Specimen Mailer And Storage, Temperature Controlled, Sterile	KDW	1	Exporter to the US	accessdata.fda.gov
Container, Specimen, Non-Sterile	NNI	1	Exporter to the US	accessdata.fda.gov
Container, Specimen, Sterile	FMH	1	Exporter to the US	accessdata.fda.gov
Continuous Measurement Thermometer	FLL	2	Exporter to the US	accessdata.fda.gov
Cover, Biopsy Forceps	FFF	1	Exporter to the US	accessdata.fda.gov
Cover, Cast	KIA	1	Exporter to the US	accessdata.fda.gov
Cover, Shoe, Operating-Room	FXP	1	Exporter to the US	accessdata.fda.gov
Culture Media, Non-Propagating Transport	JSM	1	Exporter to the US	accessdata.fda.gov
Curette, Ear	JYG	1	Exporter to the US	accessdata.fda.gov
Curette, Suction, Endometrial (And Accessories)	HHK	2	Exporter to the US	accessdata.fda.gov
Curette, Surgical, General Use	FZS	1	Exporter to the US	accessdata.fda.gov
Curette, Uterine	HCY	1	Exporter to the US	accessdata.fda.gov
Cystoscope And Accessories, Flexible/Rigid	FAJ	2	Exporter to the US	accessdata.fda.gov
Cystotome	HNY	1	Exporter to the US	accessdata.fda.gov
Dc-Defibrillator, Low-Energy, (Including Paddles)	LDD	2	Exporter to the US	accessdata.fda.gov
Depressor, Tongue, Non-Surgical	FMA	1	Exporter to the US	accessdata.fda.gov
Dermatome	GFD	1	Exporter to the US	accessdata.fda.gov
Device, Intravascular Catheter Securement	KMK	1	Exporter to the US	accessdata.fda.gov
Device, Monitoring, Intracranial Pressure	GWM	2	Exporter to the US	accessdata.fda.gov
Device, Percutaneous Retrieval	MMX	2	Exporter to the US	accessdata.fda.gov
Device, Specimen Collection	LIO	1	Exporter to the US	accessdata.fda.gov
Device, Transfer, Patient, Manual	FMR	1	Exporter to the US	accessdata.fda.gov
Devices Detecting Influenza A, B, And C Virus Antigens	PSZ	2	Exporter to the US	accessdata.fda.gov
Dialyzer, High Permeability With Or Without Sealed Dialysate System	KDI	2	Exporter to the US	accessdata.fda.gov
Dilator, Catheter, Ureteral	EZN	2	Exporter to the US	accessdata.fda.gov
Dilator, Esophageal	KNQ	2	Exporter to the US	accessdata.fda.gov
Dilator, Urethral	KOE	2	Exporter to the US	accessdata.fda.gov
Dilator, Vaginal	HDX	2	Exporter to the US	accessdata.fda.gov
Dislodger, Stone, Basket, Ureteral, Metal	FFL	2	Exporter to the US	accessdata.fda.gov
Dislodger, Stone, Biliary	LQR	2	Exporter to the US	accessdata.fda.gov
Dispenser, Liquid Medication	KYX	1	Exporter to the US	accessdata.fda.gov
Drain, Tee (Water Trap)	BYH	1	Exporter to the US	accessdata.fda.gov
Drape, Surgical, Antimicrobial	KKX	2	Exporter to the US	accessdata.fda.gov
Drape, Surgical, Exempt	PUI	2	Exporter to the US	accessdata.fda.gov
Drape, Urological, Disposable	EYY	2	Exporter to the US	accessdata.fda.gov
Dressing, Compression	MHW	1	Exporter to the US	accessdata.fda.gov
Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic	MGQ	U	Exporter to the US	accessdata.fda.gov
Dressing, Wound And Burn, Occlusive	MGP	U	Exporter to the US	accessdata.fda.gov
Dressing, Wound, Drug	FRO	U	Exporter to the US	accessdata.fda.gov
Dressing, Wound, Hydrogel Without Drug And/Or Biologic	NAE	1	Exporter to the US	accessdata.fda.gov
Dressing, Wound, Hydrophilic	NAC	1	Exporter to the US	accessdata.fda.gov
Dressing, Wound, Occlusive	NAD	1	Exporter to the US	accessdata.fda.gov
Drill, Dental, Intraoral	DZA	1	Exporter to the US	accessdata.fda.gov
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	ERL	2	Exporter to the US	accessdata.fda.gov
Drills, Burrs, Trephines & Accessories (Compound, Powered)	HBF	2	Exporter to the US	accessdata.fda.gov
Drills, Burrs, Trephines & Accessories (Manual)	HBG	2	Exporter to the US	accessdata.fda.gov
Drills, Burrs, Trephines & Accessories (Simple, Powered)	HBE	2	Exporter to the US	accessdata.fda.gov
Ear Wick	KCN	1	Exporter to the US	accessdata.fda.gov
Electrocardiograph	DPS	2	Exporter to the US	accessdata.fda.gov
Electrocautery, Gynecologic (And Accessories)	HGI	2	Exporter to the US	accessdata.fda.gov
Electrode, Cutaneous	GXY	2	Exporter to the US	accessdata.fda.gov
Electrode, Electrocardiograph	DRX	2	Exporter to the US	accessdata.fda.gov
Electrode, Electrosurgical	JOS	2	Exporter to the US	accessdata.fda.gov
Electrode, Needle	GXZ	2	Exporter to the US	accessdata.fda.gov
Electrode, Needle, Diagnostic Electromyograph	IKT	2	Exporter to the US	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Exporter to the US	accessdata.fda.gov
Elevator, Surgical, Dental	EMJ	1	Exporter to the US	accessdata.fda.gov
Endoscope, Accessories, Narrow Band Spectrum	NWB	2	Exporter to the US	accessdata.fda.gov
Endoscopic Access Overtube, Gastroenterology-Urology	FED	2	Exporter to the US	accessdata.fda.gov
Endoscopic Guidewire, Gastroenterology-Urology	OCY	2	Exporter to the US	accessdata.fda.gov
Enteral Syringes With Enteral Specific Connectors	PNR	2	Exporter to the US	accessdata.fda.gov
Exophthalmometer	HLS	1	Exporter to the US	accessdata.fda.gov
Fentanyl And Other Opioid Protection Glove	QDO	1	Exporter to the US	accessdata.fda.gov
Fiber, Medical, Absorbent	FRL	1	Exporter to the US	accessdata.fda.gov
Film, Radiographic	IWZ	1	Exporter to the US	accessdata.fda.gov
Filter, Bacterial, Breathing-Circuit	CAH	2	Exporter to the US	accessdata.fda.gov
Filter, Infusion Line	FPB	2	Exporter to the US	accessdata.fda.gov
Floss, Dental	JES	1	Exporter to the US	accessdata.fda.gov
Forceps, Biopsy, Electric	KGE	2	Exporter to the US	accessdata.fda.gov
Forceps, Biopsy, Non-Electric	FCL	1	Exporter to the US	accessdata.fda.gov
Forceps, Ent	KAE	1	Exporter to the US	accessdata.fda.gov
Fork, Tuning	GWX	1	Exporter to the US	accessdata.fda.gov
Full-Montage Standard Electroencephalograph	GWQ	2	Exporter to the US	accessdata.fda.gov
Gastrointestinal Tubes With Enteral Specific Connectors	PIF	2	Exporter to the US	accessdata.fda.gov
Gauze / Sponge,Nonresorbable For External Use	NAB	1	Exporter to the US	accessdata.fda.gov
Gauze/Sponge, Internal, X-Ray Detectable	GDY	1	Exporter to the US	accessdata.fda.gov
Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection	QPC	2	Exporter to the US	accessdata.fda.gov
Gown, Surgical	FYA	2	Exporter to the US	accessdata.fda.gov
Guard, Instrument	LXZ	1	Exporter to the US	accessdata.fda.gov
Handle, Scalpel	GDZ	1	Exporter to the US	accessdata.fda.gov
Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer	BZE	2	Exporter to the US	accessdata.fda.gov
Hemostatic Device For Endoscopic Gastrointestinal Use	QAU	2	Exporter to the US	accessdata.fda.gov
Hemostatic Metal Clip For The Gi Tract	PKL	2	Exporter to the US	accessdata.fda.gov
Holder, Head, Neurosurgical (Skull Clamp)	HBL	2	Exporter to the US	accessdata.fda.gov
Hood, Surgical	FXY	2	Exporter to the US	accessdata.fda.gov
Hook, Surgical, General & Plastic Surgery	GDG	1	Exporter to the US	accessdata.fda.gov
Humidifier, Respiratory Gas, (Direct Patient Interface)	BTT	2	Exporter to the US	accessdata.fda.gov
Hysteroscope (And Accessories)	HIH	2	Exporter to the US	accessdata.fda.gov
Indicator, Biological Sterilization Process	FRC	2	Exporter to the US	accessdata.fda.gov
Indicator, Physical/Chemical Sterilization Process	JOJ	2	Exporter to the US	accessdata.fda.gov
Infusor, Pressure, For I.V. Bags	KZD	1	Exporter to the US	accessdata.fda.gov
Instrument, Biopsy	KNW	2	Exporter to the US	accessdata.fda.gov
Instrument, Ent Manual Surgical	LRC	1	Exporter to the US	accessdata.fda.gov
Instrument, Surgical, Disposable	KDC	1	Exporter to the US	accessdata.fda.gov
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	HWE	1	Exporter to the US	accessdata.fda.gov
Instrument, Ultrasonic Surgical	LFL	U	Exporter to the US	accessdata.fda.gov
Instruments, Dental Hand	DZN	1	Exporter to the US	accessdata.fda.gov
Insufflator, Hysteroscopic	HIG	2	Exporter to the US	accessdata.fda.gov
Insufflator, Laparoscopic	HIF	2	Exporter to the US	accessdata.fda.gov
Introducer, Catheter	DYB	2	Exporter to the US	accessdata.fda.gov
Irrigator, Ostomy	EXD	2	Exporter to the US	accessdata.fda.gov
Jelly, Lubricating, For Transurethral Surgical Instrument	FHX	2	Exporter to the US	accessdata.fda.gov
Joint, Ankle, External Brace	ITW	1	Exporter to the US	accessdata.fda.gov
Knife, Ophthalmic	HNN	1	Exporter to the US	accessdata.fda.gov
Laparoscope, General & Plastic Surgery	GCJ	2	Exporter to the US	accessdata.fda.gov
Laryngoscope, Endoscope	GCI	2	Exporter to the US	accessdata.fda.gov
Laryngoscope, Rigid	CCW	1	Exporter to the US	accessdata.fda.gov
Latex Patient Examination Glove	LYY	1	Exporter to the US	accessdata.fda.gov
Lavage, Jet	FQH	2	Exporter to the US	accessdata.fda.gov
Lift, Patient, Non-Ac-Powered	FSA	1	Exporter to the US	accessdata.fda.gov
Ligator, Esophageal	MND	2	Exporter to the US	accessdata.fda.gov
Light, Surgical, Accessories	FTA	2	Exporter to the US	accessdata.fda.gov
Loop, Wire	JYQ	1	Exporter to the US	accessdata.fda.gov
Lubricant, Patient	KMJ	1	Exporter to the US	accessdata.fda.gov
Marker, Radiographic, Implantable	NEU	2	Exporter to the US	accessdata.fda.gov
Marker, Skin	FZZ	1	Exporter to the US	accessdata.fda.gov
Mask, Gas, Anesthetic	BSJ	1	Exporter to the US	accessdata.fda.gov
Mask, Oxygen	BYG	1	Exporter to the US	accessdata.fda.gov
Mask, Surgical	FXX	2	Exporter to the US	accessdata.fda.gov
Massager, Therapeutic, Manual	LYG	1	Exporter to the US	accessdata.fda.gov
Medical Glove, Specialty	LZC	1	Exporter to the US	accessdata.fda.gov
Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs	OPJ	1	Exporter to the US	accessdata.fda.gov
Meter, Peak Flow, Spirometry	BZH	2	Exporter to the US	accessdata.fda.gov
Mixer, Cement, For Clinical Use	JDZ	1	Exporter to the US	accessdata.fda.gov
Monitor, Airway Pressure (Includes Gauge And/Or Alarm)	CAP	2	Exporter to the US	accessdata.fda.gov
Monitor, Breathing Frequency	BZQ	2	Exporter to the US	accessdata.fda.gov
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	MWI	2	Exporter to the US	accessdata.fda.gov
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	MHX	2	Exporter to the US	accessdata.fda.gov
Mouthpiece, Breathing	BYP	1	Exporter to the US	accessdata.fda.gov
Mouthpiece, Saliva Ejector	DYN	1	Exporter to the US	accessdata.fda.gov
Nasopharyngoscope (Flexible Or Rigid)	EOB	2	Exporter to the US	accessdata.fda.gov
Nebulizer (Direct Patient Interface)	CAF	2	Exporter to the US	accessdata.fda.gov
Nebulizer, Medicinal, Non-Ventilatory (Atomizer)	CCQ	1	Exporter to the US	accessdata.fda.gov
Needle, Aspiration And Injection, Disposable	GAA	1	Exporter to the US	accessdata.fda.gov
Needle, Aspiration And Injection, Reusable	GDM	1	Exporter to the US	accessdata.fda.gov
Needle, Conduction, Anesthetic (W/Wo Introducer)	BSP	2	Exporter to the US	accessdata.fda.gov
Needle, Emergency Airway	BWC	2	Exporter to the US	accessdata.fda.gov
Needle, Hypodermic, Single Lumen	FMI	2	Exporter to the US	accessdata.fda.gov
Negative Pressure Wound Therapy Powered Suction Pump	OMP	2	Exporter to the US	accessdata.fda.gov
Neurological Stereotaxic Instrument	HAW	2	Exporter to the US	accessdata.fda.gov
Neurosurgical Paddie	HBA	2	Exporter to the US	accessdata.fda.gov
Non-Coring (Huber) Needle	PTI	2	Exporter to the US	accessdata.fda.gov
Non-Surgical Gown	OEA	1	Exporter to the US	accessdata.fda.gov
Ophthalmoscope, Ac-Powered	HLI	2	Exporter to the US	accessdata.fda.gov
Ophthalmoscope, Battery-Powered	HLJ	2	Exporter to the US	accessdata.fda.gov
Orthopedic Manual Surgical Instrument	LXH	1	Exporter to the US	accessdata.fda.gov
Orthosis, Lumbar	IQE	1	Exporter to the US	accessdata.fda.gov
Orthosis, Sacroiliac, Soft	IPW	1	Exporter to the US	accessdata.fda.gov
Otoscope	ERA	1	Exporter to the US	accessdata.fda.gov
Oximeter	DQA	2	Exporter to the US	accessdata.fda.gov
Oximeter, Ear	DPZ	2	Exporter to the US	accessdata.fda.gov
Oximeter, Tissue Saturation	MUD	2	Exporter to the US	accessdata.fda.gov
Pack, Hot Or Cold, Disposable	IMD	1	Exporter to the US	accessdata.fda.gov
Pack, Hot Or Cold, Reusable	IME	1	Exporter to the US	accessdata.fda.gov
Pad, Neonatal Eye	FOK	1	Exporter to the US	accessdata.fda.gov
Paper, Articulation	EFH	1	Exporter to the US	accessdata.fda.gov
Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling	PNG	2	Exporter to the US	accessdata.fda.gov
Pessary, Vaginal	HHW	2	Exporter to the US	accessdata.fda.gov
Pill Crusher/Cutter	OHY	1	Exporter to the US	accessdata.fda.gov
Polymer Patient Examination Glove	LZA	1	Exporter to the US	accessdata.fda.gov
Port & Catheter, Implanted, Subcutaneous, Intravascular	LJT	2	Exporter to the US	accessdata.fda.gov
Post, Root Canal	ELR	1	Exporter to the US	accessdata.fda.gov
Powered Laser Surgical Instrument	GEX	2	Exporter to the US	accessdata.fda.gov
Protector, Ostomy	EXE	1	Exporter to the US	accessdata.fda.gov
Protector, Skin Pressure	FMP	1	Exporter to the US	accessdata.fda.gov
Pump, Infusion	FRN	2	Exporter to the US	accessdata.fda.gov
Punch, Surgical	LRY	1	Exporter to the US	accessdata.fda.gov
Razor, Surgical	LWK	1	Exporter to the US	accessdata.fda.gov
Recorder, Paper Chart	DSF	1	Exporter to the US	accessdata.fda.gov
Respirator, Surgical	MSH	2	Exporter to the US	accessdata.fda.gov
Sampler, Amniotic Fluid (Amniocentesis Tray)	HIO	1	Exporter to the US	accessdata.fda.gov
Scalpel, One-Piece	GDX	1	Exporter to the US	accessdata.fda.gov
Scissors, General, Surgical	LRW	1	Exporter to the US	accessdata.fda.gov
Scissors, Ophthalmic	HNF	1	Exporter to the US	accessdata.fda.gov
Set, Administration, Intravascular	FPA	2	Exporter to the US	accessdata.fda.gov
Set, Blood Transfusion	BRZ	2	Exporter to the US	accessdata.fda.gov
Set, I.V. Fluid Transfer	LHI	2	Exporter to the US	accessdata.fda.gov
Set, Tubing And Support, Ventilator (W Harness)	BZO	1	Exporter to the US	accessdata.fda.gov
Set, Tubing, Blood, With And Without Anti-Regurgitation Valve	FJK	2	Exporter to the US	accessdata.fda.gov
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	HOY	1	Exporter to the US	accessdata.fda.gov
Shoe, Cast	IPG	1	Exporter to the US	accessdata.fda.gov
Shunt, Central Nervous System And Components	JXG	2	Exporter to the US	accessdata.fda.gov
Sigmoidoscope And Accessories, Flexible/Rigid	FAM	2	Exporter to the US	accessdata.fda.gov
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	FMK	2	Exporter to the US	accessdata.fda.gov
Sleeve, Limb, Compressible	JOW	2	Exporter to the US	accessdata.fda.gov
Slides, Microscope	KEW	1	Exporter to the US	accessdata.fda.gov
Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide	JKS	1	Exporter to the US	accessdata.fda.gov
Speculum, Vaginal, Metal	HDF	1	Exporter to the US	accessdata.fda.gov
Speculum, Vaginal, Nonmetal	HIB	2	Exporter to the US	accessdata.fda.gov
Spirometer, Diagnostic	BZG	2	Exporter to the US	accessdata.fda.gov
Spirometer, Monitoring (W/Wo Alarm)	BZK	2	Exporter to the US	accessdata.fda.gov
Spirometer, Therapeutic (Incentive)	BWF	2	Exporter to the US	accessdata.fda.gov
Splint, Hand, And Components	ILH	1	Exporter to the US	accessdata.fda.gov
Stand, Instrument, Ac-Powered, Ophthalmic	HMF	1	Exporter to the US	accessdata.fda.gov
Stand, Instrument, Ophthalmic, Battery Powered	NOI	1	Exporter to the US	accessdata.fda.gov
Staple, Removable (Skin)	GDT	1	Exporter to the US	accessdata.fda.gov
Stents, Drains And Dilators For The Biliary Ducts	FGE	2	Exporter to the US	accessdata.fda.gov
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	KCT	2	Exporter to the US	accessdata.fda.gov
Sterilizer, Chemical	MLR	2	Exporter to the US	accessdata.fda.gov
Stethoscope, Electronic	DQD	2	Exporter to the US	accessdata.fda.gov
Stethoscope, Manual	LDE	1	Exporter to the US	accessdata.fda.gov
Stopcock, I.V. Set	FMG	2	Exporter to the US	accessdata.fda.gov
Strip, Temperature, Forehead, Liquid Crystal	KPD	2	Exporter to the US	accessdata.fda.gov
Stylet, Tracheal Tube	BSR	1	Exporter to the US	accessdata.fda.gov
Surgeon'S Gloves	KGO	1	Exporter to the US	accessdata.fda.gov
Suture, Absorbable, Synthetic, Polyglycolic Acid	GAM	2	Exporter to the US	accessdata.fda.gov
Suture, Nonabsorbable, Synthetic, Polyamide	GAR	2	Exporter to the US	accessdata.fda.gov
Suture, Nonabsorbable, Synthetic, Polypropylene	GAW	2	Exporter to the US	accessdata.fda.gov
Suture, Surgical, Absorbable, Polydioxanone	NEW	2	Exporter to the US	accessdata.fda.gov
Syringe, Antistick	MEG	2	Exporter to the US	accessdata.fda.gov
Syringe, Ent	KCP	1	Exporter to the US	accessdata.fda.gov
Syringe, Irrigating (Non Dental)	KYZ	1	Exporter to the US	accessdata.fda.gov
Syringe, Periodontic, Endodontic, Irrigating	EIC	1	Exporter to the US	accessdata.fda.gov
Syringe, Piston	FMF	2	Exporter to the US	accessdata.fda.gov
System, Abortion, Vacuum	HHI	2	Exporter to the US	accessdata.fda.gov
System, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular Diagnostic Test	NTW	2	Exporter to the US	accessdata.fda.gov
System, Blood Culturing	MDB	1	Exporter to the US	accessdata.fda.gov
System, Hemodialysis, Remote Accessories	MON	1	Exporter to the US	accessdata.fda.gov
System, Irrigation, Urological	LJH	2	Exporter to the US	accessdata.fda.gov
System, Measurement, Blood-Pressure, Non-Invasive	DXN	2	Exporter to the US	accessdata.fda.gov
System, Test, Automated Blood Grouping And Antibody	KSZ	2	Exporter to the US	accessdata.fda.gov
System, Thermal Regulating	DWJ	2	Exporter to the US	accessdata.fda.gov
System, Transport, Aerobic	JTW	1	Exporter to the US	accessdata.fda.gov
System/Device, Pharmacy Compounding	NEP	2	Exporter to the US	accessdata.fda.gov
Tampon, Menstrual, Unscented	HEB	2	Exporter to the US	accessdata.fda.gov
Tape And Bandage, Adhesive	KGX	1	Exporter to the US	accessdata.fda.gov
Toothbrush, Manual	EFW	1	Exporter to the US	accessdata.fda.gov
Toothbrush, Powered	JEQ	1	Exporter to the US	accessdata.fda.gov
Tourniquet, Nonpneumatic	GAX	1	Exporter to the US	accessdata.fda.gov
Transducer, Pressure, Catheter Tip	DXO	2	Exporter to the US	accessdata.fda.gov
Transducer, Ultrasonic, Diagnostic	ITX	2	Exporter to the US	accessdata.fda.gov
Tray, Surgical, Instrument	FSM	1	Exporter to the US	accessdata.fda.gov
Tray, Surgical, Needle	FSH	1	Exporter to the US	accessdata.fda.gov
Trocar	DRC	2	Exporter to the US	accessdata.fda.gov
Trocar, Gastro-Urology	FBQ	2	Exporter to the US	accessdata.fda.gov
Tube Tracheostomy And Tube Cuff	JOH	2	Exporter to the US	accessdata.fda.gov
Tube, Aspirating, Flexible, Connecting	BYY	2	Exporter to the US	accessdata.fda.gov
Tube, Tracheal (W/Wo Connector)	BTR	2	Exporter to the US	accessdata.fda.gov
Tube, Tracheostomy (W/Wo Connector)	BTO	2	Exporter to the US	accessdata.fda.gov
Tube, Tympanostomy	ETD	2	Exporter to the US	accessdata.fda.gov
Tubes, Gastrointestinal (And Accessories)	KNT	2	Exporter to the US	accessdata.fda.gov
Tubes, Vacuum Sample, With Anticoagulant	GIM	2	Exporter to the US	accessdata.fda.gov
Tubes, Vials, Systems, Serum Separators, Blood Collection	JKA	2	Exporter to the US	accessdata.fda.gov
Tubing, Noninvasive	GAZ	2	Exporter to the US	accessdata.fda.gov
Tubing, Pressure And Accessories	BYX	1	Exporter to the US	accessdata.fda.gov
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	KNS	2	Exporter to the US	accessdata.fda.gov
Unit, Filter, Membrane	JRL	1	Exporter to the US	accessdata.fda.gov
Ventilator, Continuous, Facility Use	CBK	2	Exporter to the US	accessdata.fda.gov
Ventilator, Emergency, Manual (Resuscitator)	BTM	2	Exporter to the US	accessdata.fda.gov
Ventilator, Emergency, Powered (Resuscitator)	BTL	2	Exporter to the US	accessdata.fda.gov
Ventilator, Non-Continuous (Respirator)	BZD	2	Exporter to the US	accessdata.fda.gov
Vinyl Patient Examination Glove	LYZ	1	Exporter to the US	accessdata.fda.gov
Warmer, Blood, Non-Electromagnetic Radiation	BSB	2	Exporter to the US	accessdata.fda.gov
Warmer, Thermal, Infusion Fluid	LGZ	2	Exporter to the US	accessdata.fda.gov
Wire, Guide, Catheter	DQX	2	Exporter to the US	accessdata.fda.gov
Wrap, Sterilization	FRG	2	Exporter to the US	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 542.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
April 10, 2026	K252506	BD Vacutainer® Safety-Lok Blood Collection Set; BD Vacutainer® Safety-Lok Blood Collection Set with Pre-Attached Holder	JKA	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
March 13, 2026	K252040	BD Vacutainer® Plasma Separator Tubes (PST), BD Vacutainer® Sodium Heparin Blood Collection Tubes	JKA	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
July 3, 2025	K243207	BD Vacutainer® Eclipse Blood Collection Needle	JKA	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
June 27, 2025	K251654	BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter and BD Insyte Autoguard BC Pro Shielded IV Catheter	FOZ	Substantially Equivalent	Becton Dickinson Infusion Therapy Systems, Inc.	accessdata.fda.gov
March 21, 2025	K243649	BD Vacutainer® Multiple Sample Luer Adapter	JKA	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
February 28, 2025	K242339	Intravascular Extension Sets and Accessories	FPA	Substantially Equivalent	Baxter Healthcare Corporation	accessdata.fda.gov
November 27, 2024	K241353	PowerLoc Max Power Injectable Infusion Set; SafeStep Huber Needle Set	PTI	Substantially Equivalent	Bard Access Systems, Inc.	accessdata.fda.gov
November 1, 2024	K242320	BD Vacutainer® One Use Holder	JKA	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
August 23, 2024	K241780	Cardinal Health Nitrile Exam Gloves	LZA	Substantially Equivalent	Cardinal Health200, LLC	accessdata.fda.gov
February 2, 2024	K231373	BD Vacutainer® K2 EDTA Blood Collection Tubes	JKA	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
January 19, 2024	K231237	BD Vacutainer® Fluoride Blood Collection Tubes	JKA	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
December 20, 2023	K230855	BD Vacutainer® Serum Separator (SST) Blood Collection Tubes	JKA	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
September 20, 2023	K230239	AirSeal iFS System; AirSeal dV Solution	HIF	Substantially Equivalent	Conmed Corporation	accessdata.fda.gov
August 25, 2023	K213670	BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection Tubes	GIM	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
July 21, 2023	K221327	BD Alaris Pump Infusion Sets	FPA	Substantially Equivalent	Care Fusion	accessdata.fda.gov
July 7, 2023	K230080	Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Blood	JKA	Substantially Equivalent	Yangzhou Medline Industry, Co., Ltd.	accessdata.fda.gov
June 21, 2023	K223376	Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan Insulin Safety Syringe 0.5mL, 31G x 6mm (8881893150); Monoject Magellan Insulin Safety Syringe 0.3mL, 31G x 6mm (8881893130)	MEG	Substantially Equivalent	Cardinal Health200, LLC	accessdata.fda.gov
April 27, 2023	K230547	PlumePen Elite Surgical Smoke Evacuation Pencils, PlumePen Pro Surgical Smoke Evacuation Pencil, PlumePen Ultra Surgical Smoke Evacuation Pencils, PenAdapt Electrosurgical Pencil Adapter, SnapEvac Electrosurgical Pencil Adapter	GEI	Substantially Equivalent	Conmed Corporation	accessdata.fda.gov
March 24, 2023	K223236	Medline Surgical Face Mask and Medline Procedural Face Mask	FXX	Substantially Equivalent	Medline Industries, LP	accessdata.fda.gov
March 24, 2023	K220212	BD Vacutainer® Push Button Blood Collection Set, BD Vacutainer® Push Button Blood Collection Set with Pre-Attached Holder	JKA	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
March 10, 2023	K222478	BD Vacutainer® Luer-Lok Access Device, BD Vacutainer® Blood Transfer Device	JKA	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
February 17, 2023	K221513	Equashield Closed System Transfer Device	ONB	Substantially Equivalent	Equashield Medical , Ltd.	accessdata.fda.gov
December 16, 2022	K223243	BD Microtainer® Contact-Activated Lancets; BD Microtainer® Quikheel Lancets	FMK	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
November 10, 2022	K222551	Humask Pro Vision, Humask Pro Vision 3000	FXX	Substantially Equivalent	Entreprise Premont, Inc.	accessdata.fda.gov
October 26, 2022	K221218	Silverlon Wound Contact, Burn Contact Dressings	FRO	Substantially Equivalent	Argentum Medical, Inc.	accessdata.fda.gov
June 24, 2022	K220942	3M Attest Steam Chemical Integrators (1243A, 1243B, 1243RE, 1243RES)	JOJ	Substantially Equivalent	3M Company	accessdata.fda.gov
May 23, 2022	K220564	3M Comply Lead Free Steam Indicator Tape 1322, 3M Attest Lead Free Steam Indicator Tape 1355	JOJ	Substantially Equivalent	3M Company	accessdata.fda.gov
May 6, 2022	K214072	Masimo O3 Regional Oximeter System	MUD	Substantially Equivalent	Masimo Corporation	accessdata.fda.gov
May 6, 2022	K212555	Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftN, Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftNHC	DQA	Substantially Equivalent	Covidien, LLC	accessdata.fda.gov
April 1, 2022	K212216	Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 set	KDI	Substantially Equivalent	Baxter Healthcare Corporation	accessdata.fda.gov
February 4, 2022	K212724	BD Vacutainer UltraTouch Push Button Blood Collection Set	JKA	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
December 22, 2021	K210978	BD Quincke Spinal Needle, BD Whitacre Spinal Needle, BD Spinal Introducer Needle	BSP	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
October 21, 2021	K211171	CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE and accessories	CCK	Substantially Equivalent	GE Healthcare Finland Oy	accessdata.fda.gov
September 26, 2021	K201592	Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove	KGO	Substantially Equivalent	Cardinal Health200, LLC	accessdata.fda.gov
September 24, 2021	K202618	IV Administration Sets	FPA	Substantially Equivalent	B.Braun Medical, Inc.	accessdata.fda.gov
August 25, 2021	K212323	Instinct Plus Endoscopic Clipping Device	PKL	Substantially Equivalent	Wilson-Cook Medical, Inc.	accessdata.fda.gov
August 19, 2021	K211104	AirSeal® dV Solution- AirSeal® Cannula Cap and AirSeal® Bifurcated Filtered Tube Set	HIF	Substantially Equivalent	Conmed Corporation	accessdata.fda.gov
June 30, 2021	K210377	Stryker iBur hubs and cutting accessories	HBE	Substantially Equivalent	Stryker Corporation	accessdata.fda.gov
March 30, 2021	K210603	3M Bair Hugger Temperature Management System (Model 675)	DWJ	Substantially Equivalent	3M Company	accessdata.fda.gov
December 18, 2020	K201075	BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter, BD Insyte Autoguard BC Pro Shielded IV Catheter	FOZ	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
October 26, 2020	K200150	Medline Powder-Free Orange Nitrile Patient Examination Glove (Tested for use with Fentanyl)	LZA	Substantially Equivalent	Medline Industries, Inc.	accessdata.fda.gov
October 21, 2020	K201155	PleurX Peritoneal Catheter System	PNG	Unknown	Care Fusion	accessdata.fda.gov
August 27, 2020	K200881	Oral-B iO Test Drive Power Brush Trial Program Kit	JEQ	Substantially Equivalent	The Procter & Gamble Company	accessdata.fda.gov
June 10, 2020	K200972	Hemospray Endoscopic Hemostat	QAU	Substantially Equivalent	Wilson-Cook Medical, Inc.	accessdata.fda.gov
April 2, 2020	K193095	Ambu aScope 4 Cysto	FAJ	Substantially Equivalent	Ambu A/S	accessdata.fda.gov
March 21, 2020	K200493	Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical Togas, Zippered with Peel Away Face Shield, Stryker T7 Surgical Togas, Pullover	FXY	Substantially Equivalent	Stryker Corporation	accessdata.fda.gov
January 29, 2020	K191498	Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc	LJE	Unknown	Cook Incorporated	accessdata.fda.gov
January 10, 2020	K192315	Medline Green Ambidextrous Power-Free Nitrile Examination Gloves with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs)	LZA	Substantially Equivalent	Medline Industries, Inc.	accessdata.fda.gov
December 27, 2019	K191059	Masimo Rad-97 and Accessories	MWI	Substantially Equivalent	Masimo Corporation	accessdata.fda.gov
December 13, 2019	K193344	Tri-Ex Extraction Balloon with Multiple Sizing	GCA	Substantially Equivalent	Wilson-Cook Medical, Inc.	accessdata.fda.gov
November 26, 2019	K191502	Heraeus Peripheral Guidewire	DQX	Substantially Equivalent	Heraeus Medical Components, LLC	accessdata.fda.gov
October 21, 2019	K190054	BD Insulin Syringe	FMF	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
July 12, 2019	K191259	Stryker CrossFlow Integrated Arthroscopy Pump	HRX	Substantially Equivalent	Stryker Corp.	accessdata.fda.gov
May 28, 2019	K180739	Clearlink System Solution Set	FPA	Substantially Equivalent	Baxter Healthcare Corporation	accessdata.fda.gov
May 22, 2019	K191080	Ambu aScope 4 RhinoLaryngo Slim	EOB	Substantially Equivalent	Ambu A/S	accessdata.fda.gov
May 1, 2019	K183394	CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO	CCK	Substantially Equivalent	GE Healthcare Finland Oy	accessdata.fda.gov
April 30, 2019	K183540	Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip Oral/Enteral Syringes with ENFit connector (1 mL to 6 mL)	PNR	Substantially Equivalent	Neomed, Inc.	accessdata.fda.gov
April 26, 2019	K182830	Cardinal HealthTM Poly-Coated Open-Back Protective Gown	QPC	Substantially Equivalent	Cardinal Health200, LLC	accessdata.fda.gov
April 11, 2019	K190070	Sonopet iQ Ultrasonic Aspirator System	LFL	Substantially Equivalent	Stryker Corporation	accessdata.fda.gov
April 9, 2019	K181832	Transtek Blood Pressure Monitor; Welch Allyn 901123 Digital Blood Pressure Device	DXN	Substantially Equivalent	Guangdong Transtek Medical Electronics Co., Ltd.	accessdata.fda.gov
March 28, 2019	K190303	AirSeal	HIF	Substantially Equivalent	Conmed Corporation	accessdata.fda.gov
March 22, 2019	K182887	Masimo Rad-67 Pulse CO-Oximeter and Accessories	DQA	Substantially Equivalent	Masimo Corporation	accessdata.fda.gov
March 20, 2019	K183399	BD Nexiva Closed IV Catheter System	FOZ	Substantially Equivalent	Becton Dickinson Infusion Therapy Systems, Inc.	accessdata.fda.gov
March 14, 2019	K182589	BD Plastipak Syringe	FMF	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
February 11, 2019	K183166	BacT/ALERT FA Plus; BacT/ALERT PF Plus	MDB	Substantially Equivalent	bioMerieux, Inc.	accessdata.fda.gov
January 25, 2019	K182078	MiniCollect K2E K2EDTA Tubes	JKA	Substantially Equivalent	Greiner Bio-One Na, Inc.	accessdata.fda.gov
November 30, 2018	K181221	BD PhaSeal Optima Closed System Transfer Device	ONB	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
November 19, 2018	K182772	Valleylab Smoke Evacuation Rocker Switch Pencil , Valleylab Telescoping Smoke Evacuation Rocker Switch Pencil	GEI	Substantially Equivalent	Covidien	accessdata.fda.gov
November 2, 2018	K182096	Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy Drugs	LZA	Substantially Equivalent	Owens & Minor Halyard, Inc.	accessdata.fda.gov
October 23, 2018	K180046	Masimo Rad-97 and Accessories	DQA	Substantially Equivalent	Masimo Corporation	accessdata.fda.gov
September 11, 2018	K173822	Anchor Tissue Retrieval System by CONMED	GCJ	Substantially Equivalent	Conmed Corporation	accessdata.fda.gov
August 31, 2018	K173477	ChemoCLAVE Cytotoxic Medication Preparation and Delivery System	ONB	Substantially Equivalent	Icu Medical, Inc.	accessdata.fda.gov
July 23, 2018	K181242	Braun BNT400 No Touch + Forehead Thermometer	FLL	Substantially Equivalent	Kaz USA, Inc., A Helen of Troy Company	accessdata.fda.gov
June 4, 2018	K171609	Check-Flo Performer Introducer Micropuncture Radial Artery Access Set	DYB	Substantially Equivalent	Cook Incorporated	accessdata.fda.gov
May 24, 2018	K172665	Classic Cotton Cannulatome®, CannulaTome II® Double Lumen Sphincterotome, Cotton CannulaTome II® PC, UTS® Ultra Taper Sphincterotome, Tri-Tome pc® Triple Lumen Sphincterotome, Howell D.A.S.H.® Sphincterotome with DomeTip®, Billroth II Sphincterotome, Soehendra® BII Sphincterotome, Models ACU-1 and ACU-1-VL active cords	KNS	Substantially Equivalent	Wilson-Cook Medical Inc./Cook Endoscopy	accessdata.fda.gov
May 11, 2018	K172570	ALGS6 Ag Alginate Wound Dressing	FRO	Substantially Equivalent	Foshan United Medical Technologies, Ltd.	accessdata.fda.gov
May 3, 2018	K172980	Micropuncture Pedal Access Set	DYB	Substantially Equivalent	Cook Incorporated	accessdata.fda.gov
May 1, 2018	K173035	Gordon Large-Bore Curved Drainage Catheter, Nephrostomy Pigtail Drainage Catheter, Percutaneous Nephrostomy Set, Pigtail Drainage Catheter Needle Set, Multipurpose Drainage Catheters and Sets	FGE	Substantially Equivalent	Cook Incorporated	accessdata.fda.gov
April 19, 2018	K173757	VACUETTE EVOPROTECT Safety Blood Collection / Infusion Set	FMI	Substantially Equivalent	Greiner Bio-One Na, Inc.	accessdata.fda.gov
April 17, 2018	K172288	Fusion OMNI Sphincterotome	KNS	Substantially Equivalent	Wilson-Cook Medical Inc./Cook Endoscopy	accessdata.fda.gov
April 10, 2018	K173384	BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube	BTO	Substantially Equivalent	Smiths Medical Ads, Inc.	accessdata.fda.gov
March 28, 2018	K173727	Ambu aScope 3 Slim 3.8/1.2 and Ambu aScope 4 Broncho Slim 3.8/1.2; Ambu aScope 3 Regular 5.0/2.2 and Ambu aScope 4 Broncho Regular 5.0/2.2; Ambu aScope 3 Large 5.8/2.8 and Ambu aScope 4 Broncho Large 5.8/2.8; Ambu aView Monitor	EOQ	Substantially Equivalent	Ambu A/S	accessdata.fda.gov
March 9, 2018	K171764	Fixed Core Wire Guides	DQX	Substantially Equivalent	Cook Incorporated	accessdata.fda.gov
March 2, 2018	K173428	VERIFY Chemical Indicator for S40 Sterilant	JOJ	Substantially Equivalent	STERIS Corporation	accessdata.fda.gov
December 15, 2017	K173354	BD Nexiva Diffusics Closed IV Catheter Systems	FOZ	Substantially Equivalent	Becton Dickinson Infusion Therapy Systems, Inc.	accessdata.fda.gov
December 15, 2017	K172482	The Nellcor pulse oximetry monitor interface cable	DQA	Substantially Equivalent	Covidien	accessdata.fda.gov
November 21, 2017	K170754	3M Tegaderm Antimicrobial Transparent Dressing, 3M Tegaderm Antimicrobial I.V. Advanced Securement Dressing	FRO	Substantially Equivalent	3M Company, 3M Healthcare	accessdata.fda.gov
November 7, 2017	K173009	NCompass Nitinol Stone Extractors	LQR	Substantially Equivalent	Cook Incorporated	accessdata.fda.gov
October 18, 2017	K172940	ANCHOR Tissue Retrieval System	GCJ	Substantially Equivalent	Conmed Corporation	accessdata.fda.gov
September 22, 2017	K172544	IV Fat Emulsion Administration Sets	FPA	Substantially Equivalent	Baxter Healthcare Corporation	accessdata.fda.gov
August 22, 2017	K171504	VERIFY Assert VH2O2 Self-Contained Biological Indicator	FRC	Substantially Equivalent	STERIS Corporation	accessdata.fda.gov
August 10, 2017	K171116	3M VFlex Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S	MSH	Substantially Equivalent	3M Healthcare	accessdata.fda.gov
August 4, 2017	K171596	ECHO-3-22: Echotip Ultra and EUSN-1, EUSN-3: Echotip Ultrasound Needle	FCG	Substantially Equivalent	Wilson-Cook Medical, Inc.	accessdata.fda.gov
August 2, 2017	K170651	Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle	MEG	Substantially Equivalent	Yangzhou Medline Industry, Co., Ltd.	accessdata.fda.gov
July 3, 2017	K170706	Equashield Closed System drug Transfer Device (CSTD)	ONB	Substantially Equivalent	Equashield Medical , Ltd.	accessdata.fda.gov
June 9, 2017	K170762	Cardinal Health Non-Reinforced Surgical Gown	FYA	Substantially Equivalent	Cardinal Health200, LLC	accessdata.fda.gov
May 23, 2017	K161833	LATEX EXAMINATION GLOVE POWDER FREE	LYY	Substantially Equivalent	Careglove Global Sdn. Bhd.	accessdata.fda.gov
May 3, 2017	K163530	PrisMax Control Unit	KDI	Substantially Equivalent	Baxter Healthcare Corp	accessdata.fda.gov
February 17, 2017	K160200	Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyrotomy Catheter Set	BWC	Substantially Equivalent	Cook Incorporated	accessdata.fda.gov
January 6, 2017	K161463	SureClip(TM) Repositionable Hemostasis Clip	PKL	Substantially Equivalent	Micro-Tech (Nanjing) Co., Ltd.	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
August 7, 2020	P190007	Cardinal Health Multifunctional Defibrillation Electrode	MKJ	0	August 7, 2020	accessdata.fda.gov
December 27, 2017	P160022	X Series®, R Series®, AED Pro®, AED 3 BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode, SurePower	MKJ	52	October 16, 2026	accessdata.fda.gov
May 26, 2017	P160015	AED Plus and Fully Automatic AED Plus	MKJ	27	October 16, 2026	accessdata.fda.gov
June 25, 2010	P080027	ORAQUICK HCV RAPID ANTIBODY TEST	MZO	35	April 20, 2021	accessdata.fda.gov

Compare with other makers

Updated April 10, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). 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. 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.