Data / Medical devices / Netherlands / Sanicure BV

Sanicure BV: FDA-registered device maker in SCHIPHOL Noord-Holland, Netherlands, 590 510(k) clearances and 2 PMA approvals

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

Sanicure BV is registered with the FDA (registration 3012494290) in SCHIPHOL Noord-Holland, Netherlands. It lists 414 device types. The FDA files 590 510(k) clearances and 2 PMA approvals under its listings, the newest dated March 11, 2026. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3012494290
Address: Evert van de Beekstraat 104, SCHIPHOL Noord-Holland, Netherlands, 11118 CN
Owner or operator: Sanicure BV (10052769)
Roles: Exporter to the US
First device listed: January 3, 2017
Registered through: 2027
Brand names listed: ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION, AGENT, TOOTH BONDING, RESIN, ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE, Attest Indicator, CEMENT, DENTAL, CLAVE Vial Access Spike, Container, sharps, EBG - CROWN AND BRIDGE, TEMPORARY, RESIN EBF - Material, tooth shade, resin and more

Devices it lists

Device	Product code	Class	Role	Source
Absorber, Carbon-Dioxide	BSF	1	Exporter to the US	accessdata.fda.gov
Absorber, Saliva, Paper	KHR	1	Exporter to the US	accessdata.fda.gov
Accessories, Arthroscopic	NBH	1	Exporter to the US	accessdata.fda.gov
Accessories, Blood Circuit, Hemodialysis	KOC	2	Exporter to the US	accessdata.fda.gov
Accessories, Catheter	KGZ	1	Exporter to the US	accessdata.fda.gov
Accessories, Cleaning Brushes, For Endoscope	MNL	1	Exporter to the US	accessdata.fda.gov
Accessories, Implant, Dental, Endosseous	NDP	1	Exporter to the US	accessdata.fda.gov
Accessory, Surgical Apparel	LYU	1	Exporter to the US	accessdata.fda.gov
Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)	JMA	1	Exporter to the US	accessdata.fda.gov
Activator, Ultraviolet, For Polymerization	EBZ	2	Exporter to the US	accessdata.fda.gov
Adhesive, Bracket And Tooth Conditioner, Resin	DYH	2	Exporter to the US	accessdata.fda.gov
Agent, Tooth Bonding, Resin	KLE	2	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
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
Antigens, Cf (Including Cf Control), Influenza Virus A, B, C	GNX	1	Exporter to the US	accessdata.fda.gov
Antisera, All Groups, Streptococcus Spp.	GTZ	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
Apparatus, Suction, Ward Use, Portable, Ac-Powered	JCX	2	Exporter to the US	accessdata.fda.gov
Applicator, Absorbent Tipped, Sterile	KXG	1	Exporter to the US	accessdata.fda.gov
Applicator, Resin	KXR	1	Exporter to the US	accessdata.fda.gov
Applier, Hemostatic Clip	HBT	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
Aspirator, Endometrial	HFF	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
Automated Urinalysis System	KQO	1	Exporter to the US	accessdata.fda.gov
Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	JJB	1	Exporter to the US	accessdata.fda.gov
Bag, Urinary, Ileostomy	EXH	1	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
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
Bit, Drill	HTW	1	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, Occult, Colorimetric, In Urine	JIO	2	Exporter to the US	accessdata.fda.gov
Blower, Powder, Ent	KCL	1	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, Biopsy, Bronchoscope (Non-Rigid)	BTG	2	Exporter to the US	accessdata.fda.gov
Bulb, Inflation, For Endoscope	FCY	1	Exporter to the US	accessdata.fda.gov
Bur, Dental	EJL	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
C. Difficile Toxin Gene Amplification Assay	OZN	2	Exporter to the US	accessdata.fda.gov
Cannula, Manipulator/Injector, Uterine	LKF	2	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
Cap, Device Disinfectant	QBP	2	Exporter to the US	accessdata.fda.gov
Cap, Surgical	FYF	1	Exporter to the US	accessdata.fda.gov
Catheter, Intravascular, Diagnostic	DQO	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, Percutaneous	DQY	2	Exporter to the US	accessdata.fda.gov
Catheter, Peritoneal	GBW	1	Exporter to the US	accessdata.fda.gov
Catheter, Ventricular, General & Plastic Surgery	GBS	1	Exporter to the US	accessdata.fda.gov
Catheters, Suction, Tracheobronchial	BSY	1	Exporter to the US	accessdata.fda.gov
Cement, Dental	EMA	2	Exporter to the US	accessdata.fda.gov
Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use	JQC	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
Clinical Sample Concentrator	JJH	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
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
Connector, Ureteral Catheter	EYK	1	Exporter to the US	accessdata.fda.gov
Conserver, Oxygen	NFB	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, Sterile	KDT	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
Cord, Retraction	MVL	U	Exporter to the US	accessdata.fda.gov
Cotton, Roll	EFN	1	Exporter to the US	accessdata.fda.gov
Counter, Sponge, Surgical	LWH	1	Exporter to the US	accessdata.fda.gov
Cover, Barrier, Protective	MMP	2	Exporter to the US	accessdata.fda.gov
Coverslips, Microscope Slide	KES	1	Exporter to the US	accessdata.fda.gov
Crown And Bridge, Temporary, Resin	EBG	2	Exporter to the US	accessdata.fda.gov
Crown, Preformed	ELZ	1	Exporter to the US	accessdata.fda.gov
Culture Media, Non-Propagating Transport	JSM	1	Exporter to the US	accessdata.fda.gov
Cup, Prophylaxis	EHK	1	Exporter to the US	accessdata.fda.gov
Curette, Periodontic	EMS	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
Cystotome	HNY	1	Exporter to the US	accessdata.fda.gov
Dam, Rubber	EIE	1	Exporter to the US	accessdata.fda.gov
Device, Intravascular Catheter Securement	KMK	1	Exporter to the US	accessdata.fda.gov
Device, Irrigation, Ocular Surgery	KYG	1	Exporter to the US	accessdata.fda.gov
Device, Patient Transfer, Powered	FRZ	2	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
Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	JMT	1	Exporter to the US	accessdata.fda.gov
Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	CDM	1	Exporter to the US	accessdata.fda.gov
Die, Wire Bending, Ent, Sterile	JXW	1	Exporter to the US	accessdata.fda.gov
Dilator, Esophageal	KNQ	2	Exporter to the US	accessdata.fda.gov
Dish, Tissue Culture	KIZ	1	Exporter to the US	accessdata.fda.gov
Dislodger, Stone, Basket, Ureteral, Metal	FFL	2	Exporter to the US	accessdata.fda.gov
Dispenser, Liquid Medication	KYX	1	Exporter to the US	accessdata.fda.gov
Dna Probe, Gardnerella Vaginalis	MJM	1	Exporter to the US	accessdata.fda.gov
Dna Probe, Yeast	MLA	1	Exporter to the US	accessdata.fda.gov
Dna-Reagents, Neisseria	LSL	2	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
Dressing, Compression	MHW	1	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 (Simple, Powered)	HBE	2	Exporter to the US	accessdata.fda.gov
Dye-Indicator, Ph (Urinary, Non-Quantitative)	CEN	1	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, Electrocardiograph, Multi-Function	MLN	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
Elevator, Surgical, General & Plastic Surgery	GEG	1	Exporter to the US	accessdata.fda.gov
Endoscopic Bite Block	MNK	1	Exporter to the US	accessdata.fda.gov
Endoscopic Ultrasound System, Gastroenterology-Urology	ODG	2	Exporter to the US	accessdata.fda.gov
Enteral Specific Transition Connectors	PIO	2	Exporter to the US	accessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)	LJC	1	Exporter to the US	accessdata.fda.gov
Esthesiometer	GXB	1	Exporter to the US	accessdata.fda.gov
Evacuator, Gastro-Urology	KQT	2	Exporter to the US	accessdata.fda.gov
Evacuator, Oral Cavity	EHZ	1	Exporter to the US	accessdata.fda.gov
Exerciser, Finger, Powered	JFA	1	Exporter to the US	accessdata.fda.gov
Exophthalmometer	HLS	1	Exporter to the US	accessdata.fda.gov
Fastener, Fixation, Nondegradable, Soft Tissue	MBI	2	Exporter to the US	accessdata.fda.gov
Fentanyl And Other Opioid Protection Glove	QDO	1	Exporter to the US	accessdata.fda.gov
File, Pulp Canal, Endodontic	EKS	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
Forceps	HTD	1	Exporter to the US	accessdata.fda.gov
Forceps, Biopsy, Non-Electric	FCL	1	Exporter to the US	accessdata.fda.gov
Forceps, General & Plastic Surgery	GEN	1	Exporter to the US	accessdata.fda.gov
Forceps, Rubber Dam Clamp	EJG	1	Exporter to the US	accessdata.fda.gov
Forceps, Tooth Extractor, Surgical	EMG	1	Exporter to the US	accessdata.fda.gov
Formulations, Paraffin, All	KEO	1	Exporter to the US	accessdata.fda.gov
Full-Montage Standard Electroencephalograph	GWQ	2	Exporter to the US	accessdata.fda.gov
Gag, Mouth	KBN	1	Exporter to the US	accessdata.fda.gov
Garment, Protective, For Incontinence	EYQ	1	Exporter to the US	accessdata.fda.gov
Gastroscope And Accessories, Flexible/Rigid	FDS	2	Exporter to the US	accessdata.fda.gov
Gauge, Depth, Instrument, Dental	EIL	1	Exporter to the US	accessdata.fda.gov
Gauze / Sponge,Nonresorbable For External Use	NAB	1	Exporter to the US	accessdata.fda.gov
General Purpose Reagent	PPM	1	Exporter to the US	accessdata.fda.gov
Gown, Surgical	FYA	2	Exporter to the US	accessdata.fda.gov
Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System	PGX	2	Exporter to the US	accessdata.fda.gov
Guide, Surgical, Instrument	FZX	1	Exporter to the US	accessdata.fda.gov
Gutta-Percha	EKM	1	Exporter to the US	accessdata.fda.gov
Hand, External Limb Component, Powered	IQZ	1	Exporter to the US	accessdata.fda.gov
Handpiece, Air-Powered, Dental	EFB	1	Exporter to the US	accessdata.fda.gov
Handpiece, Air-Powered, Root Canal Irrigation	NYL	1	Exporter to the US	accessdata.fda.gov
Handpiece, Belt And/Or Gear Driven, Dental	EFA	1	Exporter to the US	accessdata.fda.gov
Handpiece, Contra- And Right-Angle Attachment, Dental	EGS	1	Exporter to the US	accessdata.fda.gov
Handpiece, Rotary Bone Cutting	KMW	2	Exporter to the US	accessdata.fda.gov
Head, Surgical, Hammer	GFB	1	Exporter to the US	accessdata.fda.gov
Hearing Aid, Air-Conduction, Prescription	ESD	1	Exporter to the US	accessdata.fda.gov
Helicobacter Pylori	LYR	1	Exporter to the US	accessdata.fda.gov
Hemostat, Surgical	EMD	1	Exporter to the US	accessdata.fda.gov
Hemostatic Metal Clip For The Gi Tract	PKL	2	Exporter to the US	accessdata.fda.gov
Holder, Film, X-Ray	EGZ	1	Exporter to the US	accessdata.fda.gov
Holder, Needle, Gastroenterologic	FHQ	1	Exporter to the US	accessdata.fda.gov
Hood, Surgical	FXY	2	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 Method, Protein Or Albumin (Urinary, Non-Quant.)	JIR	1	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
Influenza A And Influenza B Multiplex Nucleic Acid Assay	OZE	2	Exporter to the US	accessdata.fda.gov
Instrument, Biopsy	KNW	2	Exporter to the US	accessdata.fda.gov
Instrument, Cast Removal, Ac-Powered	LGH	1	Exporter to the US	accessdata.fda.gov
Instrument, Cutting, Operative	EKD	1	Exporter to the US	accessdata.fda.gov
Instrument, Diamond, Dental	DZP	1	Exporter to the US	accessdata.fda.gov
Instrument, Ent Manual Surgical	LRC	1	Exporter to the US	accessdata.fda.gov
Instrument, Manual, Surgical, General Use	MDM	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, Laparoscopic	HIF	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
Knife, Surgical	EMF	1	Exporter to the US	accessdata.fda.gov
Lamp, Operating-Room	FQP	2	Exporter to the US	accessdata.fda.gov
Laparoscope, General & Plastic Surgery	GCJ	2	Exporter to the US	accessdata.fda.gov
Laparoscope, Gynecologic (And Accessories)	HET	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
Lead, Atomic Absorption	DOF	2	Exporter to the US	accessdata.fda.gov
Ligator, Esophageal	MND	2	Exporter to the US	accessdata.fda.gov
Ligator, Hemorrhoidal	FHN	2	Exporter to the US	accessdata.fda.gov
Liner, Cavity, Calcium Hydroxide	EJK	2	Exporter to the US	accessdata.fda.gov
Locator, Root Apex	LQY	U	Exporter to the US	accessdata.fda.gov
Marker, Ocular	HMR	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, Scavenging	KHA	1	Exporter to the US	accessdata.fda.gov
Mask, Surgical	FXX	2	Exporter to the US	accessdata.fda.gov
Material, Impression	ELW	2	Exporter to the US	accessdata.fda.gov
Material, Tooth Shade, Resin	EBF	2	Exporter to the US	accessdata.fda.gov
Media, Electroconductive	GYB	2	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
Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	JIL	2	Exporter to the US	accessdata.fda.gov
Micro Pipette	JRC	1	Exporter to the US	accessdata.fda.gov
Mirror, Mouth	EAX	1	Exporter to the US	accessdata.fda.gov
Mixer, Cement, For Clinical Use	JDZ	1	Exporter to the US	accessdata.fda.gov
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	DRT	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
Mouthpiece, Breathing	BYP	1	Exporter to the US	accessdata.fda.gov
Multi-Analyte Controls, All Kinds (Assayed)	JJY	1	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
Neurological Stereotaxic Instrument	HAW	2	Exporter to the US	accessdata.fda.gov
Neurosurgical Paddie	HBA	2	Exporter to the US	accessdata.fda.gov
Nipper, Malleus	JYR	1	Exporter to the US	accessdata.fda.gov
Nitroprusside, Ketones (Urinary, Non-Quant.)	JIN	1	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, Cervical	IQK	1	Exporter to the US	accessdata.fda.gov
Orthosis, Corrective Shoe	KNP	1	Exporter to the US	accessdata.fda.gov
Orthosis, Limb Brace	IQI	1	Exporter to the US	accessdata.fda.gov
Orthosis, Lumbar	IQE	1	Exporter to the US	accessdata.fda.gov
Orthosis, Thoracic	IPT	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
Pin, Fixation, Smooth	HTY	2	Exporter to the US	accessdata.fda.gov
Pin, Retentive And Splinting, And Accessory Instruments	EBL	1	Exporter to the US	accessdata.fda.gov
Plaque Disclosing Agent	QJC	1	Exporter to the US	accessdata.fda.gov
Pliers, Surgical	HTC	1	Exporter to the US	accessdata.fda.gov
Plugger, Root Canal, Endodontic	EKR	1	Exporter to the US	accessdata.fda.gov
Pneumoperitoneum Needle	FHO	2	Exporter to the US	accessdata.fda.gov
Point Of Care Hiv Serology Diagnostic And/Or Supplemental Test	QSU	2	Exporter to the US	accessdata.fda.gov
Point, Abrasive	EHL	1	Exporter to the US	accessdata.fda.gov
Point, Silver, Endodontic	EKL	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
Pouch, Colostomy	EZQ	1	Exporter to the US	accessdata.fda.gov
Powder, Porcelain	EIH	2	Exporter to the US	accessdata.fda.gov
Products, Red-Cell Lysing Products	GGK	1	Exporter to the US	accessdata.fda.gov
Protector, Silicate	EFX	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
Pump, Nebulizer, Manual	EPN	1	Exporter to the US	accessdata.fda.gov
Punch, Surgical	LRY	1	Exporter to the US	accessdata.fda.gov
Pusher, Band, Orthodontic	ECS	1	Exporter to the US	accessdata.fda.gov
Rasp	HTR	1	Exporter to the US	accessdata.fda.gov
Razor, Surgical	LWK	1	Exporter to the US	accessdata.fda.gov
Real Time Nucleic Acid Amplification System	OOI	2	Exporter to the US	accessdata.fda.gov
Recorder, Paper Chart	DSF	1	Exporter to the US	accessdata.fda.gov
Refractometer For Clinical Use	JRE	1	Exporter to the US	accessdata.fda.gov
Resin, Denture, Relining, Repairing, Rebasing	EBI	2	Exporter to the US	accessdata.fda.gov
Resin, Root Canal Filling	KIF	2	Exporter to the US	accessdata.fda.gov
Respirator, Surgical	MSH	2	Exporter to the US	accessdata.fda.gov
Respiratory Virus Panel Nucleic Acid Assay System	OCC	2	Exporter to the US	accessdata.fda.gov
Retainer, Matrix	JEP	1	Exporter to the US	accessdata.fda.gov
Retractor	GAD	1	Exporter to the US	accessdata.fda.gov
Retractor, All Types	EIG	1	Exporter to the US	accessdata.fda.gov
Retractor, Self-Retaining	FFO	1	Exporter to the US	accessdata.fda.gov
Saline, Vascular Access Flush	NGT	2	Exporter to the US	accessdata.fda.gov
Saw, Electrically Powered	DWI	1	Exporter to the US	accessdata.fda.gov
Saw, Powered, And Accessories	HAB	1	Exporter to the US	accessdata.fda.gov
Scaler, Periodontic	EMN	1	Exporter to the US	accessdata.fda.gov
Scaler, Ultrasonic	ELC	2	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
Sealant, Microbial	NZP	2	Exporter to the US	accessdata.fda.gov
Sealant, Pit And Fissure, And Conditioner	EBC	2	Exporter to the US	accessdata.fda.gov
Set, Administration, Intravascular	FPA	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
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	HOY	1	Exporter to the US	accessdata.fda.gov
Sigmoidoscope And Accessories, Flexible/Rigid	FAM	2	Exporter to the US	accessdata.fda.gov
Single (Specified) Analyte Controls (Assayed And Unassayed)	JJX	1	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
Sling, Arm	ILI	1	Exporter to the US	accessdata.fda.gov
Snare, Flexible	FDI	2	Exporter to the US	accessdata.fda.gov
Snare, Nasal	KBE	1	Exporter to the US	accessdata.fda.gov
Solid State X-Ray Imager (Flat Panel/Digital Imager)	MQB	2	Exporter to the US	accessdata.fda.gov
Solvent, Adhesive Tape	KOX	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, Therapeutic (Incentive)	BWF	2	Exporter to the US	accessdata.fda.gov
Splint, Extremity, Non-Inflatable, External, Non-Sterile	NOC	1	Exporter to the US	accessdata.fda.gov
Splint, Hand, And Components	ILH	1	Exporter to the US	accessdata.fda.gov
Splint, Nasal	EPP	1	Exporter to the US	accessdata.fda.gov
Sponge, Ophthalmic	HOZ	2	Exporter to the US	accessdata.fda.gov
Spreader, Bladder Neck	FHK	1	Exporter to the US	accessdata.fda.gov
Staple, Removable (Skin)	GDT	1	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
Stocking, Medical Support (For General Medical Purposes)	FQL	1	Exporter to the US	accessdata.fda.gov
Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)	DWL	2	Exporter to the US	accessdata.fda.gov
Strap, Head, Gas Mask	BTK	1	Exporter to the US	accessdata.fda.gov
Strip, Polishing Agent	EHM	1	Exporter to the US	accessdata.fda.gov
Stylet, Tracheal Tube	BSR	1	Exporter to the US	accessdata.fda.gov
Suction Control, Intracardiac, Cardiopulmonary Bypass	DWD	2	Exporter to the US	accessdata.fda.gov
Support, Arm	IOY	1	Exporter to the US	accessdata.fda.gov
Support, Breathing Tube	JAY	1	Exporter to the US	accessdata.fda.gov
Support, Patient Position	CCX	1	Exporter to the US	accessdata.fda.gov
Surgeon'S Gloves	KGO	1	Exporter to the US	accessdata.fda.gov
Suture, Absorbable, Natural	GAL	2	Exporter to the US	accessdata.fda.gov
Suture, Absorbable, Synthetic, Polyglycolic Acid	GAM	2	Exporter to the US	accessdata.fda.gov
Suture, Nonabsorbable, Silk	GAP	2	Exporter to the US	accessdata.fda.gov
Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile	GAQ	2	Exporter to the US	accessdata.fda.gov
Suture, Nonabsorbable, Synthetic, Polyamide	GAR	2	Exporter to the US	accessdata.fda.gov
Suture, Nonabsorbable, Synthetic, Polyethylene	GAT	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
Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene	NBY	2	Exporter to the US	accessdata.fda.gov
Syringe, Antistick	MEG	2	Exporter to the US	accessdata.fda.gov
Syringe, Balloon Inflation, Exempt	PTM	2	Exporter to the US	accessdata.fda.gov
Syringe, Cartridge	EJI	2	Exporter to the US	accessdata.fda.gov
Syringe, Irrigating (Non Dental)	KYZ	1	Exporter to the US	accessdata.fda.gov
Syringe, Piston	FMF	2	Exporter to the US	accessdata.fda.gov
Syringe, Restorative And Impression Material	EID	1	Exporter to the US	accessdata.fda.gov
System, Abortion, Vacuum	HHI	2	Exporter to the US	accessdata.fda.gov
System, Hemoglobin, Automated	GKR	2	Exporter to the US	accessdata.fda.gov
System, Imaging, Pulsed Echo, Ultrasonic	IYO	2	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, Peritoneal, Automatic Delivery	FKX	2	Exporter to the US	accessdata.fda.gov
System, Test, Infectious Mononucleosis	KTN	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, X-Ray, Extraoral Source, Digital	MUH	2	Exporter to the US	accessdata.fda.gov
Table, Examination, Medical, Powered	LGX	1	Exporter to the US	accessdata.fda.gov
Table, Operating-Room, Pneumatic	FWW	1	Exporter to the US	accessdata.fda.gov
Tape And Bandage, Adhesive	KGX	1	Exporter to the US	accessdata.fda.gov
Test, Urine Leukocyte	LJX	1	Exporter to the US	accessdata.fda.gov
Tester, Pulp	EAT	2	Exporter to the US	accessdata.fda.gov
Tissue Adhesive For The Topical Approximation Of Skin	MPN	2	Exporter to the US	accessdata.fda.gov
Topical Approximation System	MZR	1	Exporter to the US	accessdata.fda.gov
Tourniquet, Pneumatic	KCY	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
Transilluminator, Battery-Powered	HJN	1	Exporter to the US	accessdata.fda.gov
Transmitters And Receivers, Physiological Signal, Radiofrequency	DRG	2	Exporter to the US	accessdata.fda.gov
Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)	FCM	2	Exporter to the US	accessdata.fda.gov
Tray, Impression, Preformed	EHY	1	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, 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, Collection, Capillary Blood	GIO	1	Exporter to the US	accessdata.fda.gov
Tube, Feeding	FPD	2	Exporter to the US	accessdata.fda.gov
Tube, Gastro-Enterostomy	KGC	2	Exporter to the US	accessdata.fda.gov
Tube, Nasogastric	BSS	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, 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

14 more device types in the FDA listing

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 590.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
March 11, 2026	K260783	Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One	EBF	Substantially Equivalent	Kulzer, LLC	accessdata.fda.gov
November 25, 2024	K242538	3M Attest Super Rapid Readout Biological Indicator 1493; 3M Attest Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG; 3M Attest Auto-reader 490; 3M Attest Auto-reader 490H; 3M Attest Mini Auto-reader 490M	FRC	Substantially Equivalent	3M Company	accessdata.fda.gov
September 12, 2024	K241710	3M Attest Super Rapid Readout Biological Indicator 1492V; 3M Attest Auto-reader 490; 3M Attest Auto-reader 490H; 3M Attest Mini Auto-reader 490M	FRC	Substantially Equivalent	3M Company	accessdata.fda.gov
March 22, 2024	K231938	Halyard STERLING* Nitrile Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid; Halyard STERLING SG* SENSI-GUARD Powder-Free Nitrile Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid; Halyard STERLING NITRILE-XTRA * Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid	LZA	Substantially Equivalent	O&M Halyard, Inc.	accessdata.fda.gov
January 12, 2024	K233022	Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 2 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, White, Regular and Small	MSH	Substantially Equivalent	Owens & Minor (O&M) Halyard, Inc.	accessdata.fda.gov
November 9, 2023	K231724	Flush Syringe (Prefilled 0.9% normal saline solution)	NGT	Substantially Equivalent	Spm Medicare Pvt. , Ltd.	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	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 2, 2023	K223352	Tenderfoot	FMK	Substantially Equivalent	Accriva Diagnostics, Inc.	accessdata.fda.gov
September 23, 2022	K222152	3M Attest Hydrogen Peroxide Indicator Tape 1228	JOJ	Substantially Equivalent	3M Company	accessdata.fda.gov
July 8, 2022	K220643	DropSafe Acti-Lance Safety Lancets; droplet ACTI-LANCE Safety Lancets, DropSafe Medlance Plus Safety Lancets; droplet MEDLANCE PLUS Safety Lancets, DropSafe ergoLance Safety Lancets, DropSafe Prolance Safety Lancets, DropSafe Medisafe Solo Safety Lancets; DropSafe Haemolance Plus Safety Lancets	FMK	Substantially Equivalent	Htl-Strefa S.A	accessdata.fda.gov
June 24, 2022	K220942	3M Attest Steam Chemical Integrators (1243A, 1243B, 1243RE, 1243RES)	JOJ	Substantially Equivalent	3M Company	accessdata.fda.gov
June 13, 2022	K221695	3M Filtek Supreme Flowable Restorative	EBF	Substantially Equivalent	3M Company Espe Dental Products	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
February 24, 2022	K210135	PROMOGRAN PRISMA Matrix, Small Dressing, PROMOGRAN PRISMA Matrix, Large Dressing	FRO	Substantially Equivalent	3M Healthcare Business Group	accessdata.fda.gov
February 1, 2022	K220257	Permadyne	ELW	Substantially Equivalent	3M Deutschland GmbH	accessdata.fda.gov
January 20, 2022	K212748	Disposable Dual Action Tissue Clip	PKL	Substantially Equivalent	Micro-Tech (Nanjing) Co., Ltd.	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
July 2, 2020	K200766	3M Attest Steam Chemical Integrator Test Pack	FRC	Substantially Equivalent	3M Company	accessdata.fda.gov
May 5, 2020	K201184	Lascod Impression Materials	ELW	Substantially Equivalent	Lascod Spa	accessdata.fda.gov
December 13, 2019	K193344	Tri-Ex Extraction Balloon with Multiple Sizing	GCA	Substantially Equivalent	Wilson-Cook Medical, Inc.	accessdata.fda.gov
October 24, 2019	K181660	Acapella Choice Blue Vibratory PEP Device	BWF	Substantially Equivalent	Smiths Medical	accessdata.fda.gov
July 12, 2019	K191259	Stryker CrossFlow Integrated Arthroscopy Pump	HRX	Substantially Equivalent	Stryker Corp.	accessdata.fda.gov
May 17, 2019	K183035	Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part Trocar Needle	LJE	Unknown	Cook Incorporated	accessdata.fda.gov
April 11, 2019	K190070	Sonopet iQ Ultrasonic Aspirator System	LFL	Substantially Equivalent	Stryker 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 13, 2019	K183600	Anchor Bag-Alone Tissue Retrieval System by ConMed	GCJ	Substantially Equivalent	Conmed Corporation	accessdata.fda.gov
January 20, 2019	K183581	Codman Disposable Perforators	HBF	Substantially Equivalent	Integra Lifesciences Corp.	accessdata.fda.gov
January 2, 2019	K183476	3M Filtek Universal Restorative	EBF	Substantially Equivalent	3M Espe Dental Products	accessdata.fda.gov
December 19, 2018	K180846	Arterial Pressure Monitoring Set/Tray	DQO	Unknown	Cook Incorporated	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
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
April 23, 2018	K173519	3M Attest Super Rapid Readout Steam Challenge Pack, 3M Attest Super Rapid 5 Steam-Plus Chaallenge Pack, 3M Attest Auto-reader, 3M Attest Auto-reader	FRC	Substantially Equivalent	3M Company	accessdata.fda.gov
April 17, 2018	K172288	Fusion OMNI Sphincterotome	KNS	Substantially Equivalent	Wilson-Cook Medical Inc./Cook Endoscopy	accessdata.fda.gov
April 6, 2018	K180630	PTFE SURGICAL SUTURE	NBY	Substantially Equivalent	Omnia Spa	accessdata.fda.gov
February 22, 2018	K171823	U&U Indicator tape and strip	JOJ	Substantially Equivalent	U&U Medical Technology Co, Ltd.	accessdata.fda.gov
January 22, 2018	K173584	3M Attest Super Rapid Readout Biological Indicator, 3M Attest Auto-reader, 3M Attest Auto-reader	FRC	Substantially Equivalent	3M Company	accessdata.fda.gov
January 18, 2018	K171237	FMS VUE II Fluid Management and Tissue Debridement System	HRX	Substantially Equivalent	Medos International SARL	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
October 18, 2017	K172940	ANCHOR Tissue Retrieval System	GCJ	Substantially Equivalent	Conmed Corporation	accessdata.fda.gov
September 21, 2017	K161719	Salter Labs Bubble Humidifier	BTT	Substantially Equivalent	Salter Labs	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
May 11, 2017	K170491	Solana C. difficile Assay	OZN	Substantially Equivalent	Quidel Corporation	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
February 3, 2017	K162536	GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium Sulfate Retraction Cord	MVL	Substantially Equivalent	Kerr Corporation	accessdata.fda.gov
December 19, 2016	K162081	BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse Hypodermic Needle, BD 1ml Luer-lok Insulin Syringe	FMF	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
November 28, 2016	K163207	Filtek One Bulk Fill Restorative	EBF	Substantially Equivalent	3M Company	accessdata.fda.gov
November 15, 2016	K160049	Charisma	EBF	Substantially Equivalent	Heraeus Kulzer, LLC (Mitsui Chemicals Group)	accessdata.fda.gov
October 25, 2016	K162274	Solana Strep Complete Assay	PGX	Substantially Equivalent	Quidel Corporation	accessdata.fda.gov
September 27, 2016	K161814	Solana Influenza A+B Assay	OCC	Substantially Equivalent	Quidel Corporation	accessdata.fda.gov
July 27, 2016	K153067	Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT Xpress	KIF	Substantially Equivalent	Sybron Dental Specialties	accessdata.fda.gov
May 27, 2016	K152826	NoCord	ELW	Substantially Equivalent	Centrix, Inc.	accessdata.fda.gov
May 6, 2016	K152956	Pulp Canal Sealer, Pulp Canal Sealer EWT	KIF	Substantially Equivalent	Sybron Dental Specialties	accessdata.fda.gov
April 28, 2016	K152927	BRILLIANT EVERGLOW	EBF	Substantially Equivalent	Coltene/Whaledent AG	accessdata.fda.gov
April 14, 2016	K152959	Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes	KIF	Substantially Equivalent	Sybron Dental Specialties	accessdata.fda.gov
April 13, 2016	K153174	Ketac Universal Aplicap	EMA	Substantially Equivalent	3M Deutschland GmbH	accessdata.fda.gov
April 6, 2016	K153293	Extension Set	FPA	Substantially Equivalent	B.Braun Medical, Inc.	accessdata.fda.gov
March 31, 2016	K151932	Stryker CrossFlow Day-Use Inflow Cassette Tubing and Patient-Use Tubing	HRX	Substantially Equivalent	Stryker Corporation	accessdata.fda.gov
March 10, 2016	K151421	Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample Lines	CCK	Substantially Equivalent	Salter Labs	accessdata.fda.gov
March 4, 2016	K152861	Aquasil Ultra + Smart Wetting Impression Material	ELW	Substantially Equivalent	Dentply International, Inc.	accessdata.fda.gov
March 1, 2016	K152748	Braun Thermoscan PRO 6000 Ear Thermometer	FLL	Substantially Equivalent	Kaz USA, Inc (A Subsidiary of Helen of Troy, Inc)	accessdata.fda.gov
February 9, 2016	K152476	Exofin High Viscosity Tissue Adhesive	MPN	Substantially Equivalent	Chemence Medical Products, Inc.	accessdata.fda.gov
January 14, 2016	K150032	GluStitch Twist Tissue Adhesive	MPN	Substantially Equivalent	Glustitch, Inc.	accessdata.fda.gov
December 1, 2015	K152060	3M Attest Rapid Readout Biological Indicator 1295	FRC	Substantially Equivalent	3M Company	accessdata.fda.gov
November 23, 2015	K143704	Advanced Air System	EFB	Substantially Equivalent	W&H Dentalwerk Buermoos GmbH	accessdata.fda.gov
October 21, 2015	K152770	ProBP 2400 Digital Blood Pressure Device	DXN	Substantially Equivalent	Microlife Intellectual Property GmbH	accessdata.fda.gov
September 10, 2015	K151526	Zone, ZoneFree, Zone A1	EMA	Substantially Equivalent	Sybron Dental Specialties	accessdata.fda.gov
September 9, 2015	K143637	U&U Sterilization Pouch and Roll	FRG	Substantially Equivalent	U&U Medical Technology Co, Ltd.	accessdata.fda.gov
July 27, 2015	K151698	BD Angiocath IV Catheter, BD Insyte IV Catheter	FOZ	Substantially Equivalent	Becton Dickinson Infusion Therapy Systems, Inc.	accessdata.fda.gov
July 7, 2015	K150933	iBond Universal & iBond Ceramic Primer	KLE	Substantially Equivalent	Heraeus Kulzer, LLC, Mitsui Chemicals Group	accessdata.fda.gov
June 23, 2015	K150868	Solana GAS Assay, Solana instrument	PGX	Substantially Equivalent	Quidel Corporation	accessdata.fda.gov
June 10, 2015	K150569	LaparoVue	GCJ	Substantially Equivalent	Buffalo Filter, LLC	accessdata.fda.gov
June 9, 2015	K150034	AMT Enteral Transition Adapters	PIO	Substantially Equivalent	Applied Medical Technology, Inc.	accessdata.fda.gov
May 8, 2015	K150333	MedSource Sharps Dart	MMK	Substantially Equivalent	Medsource International, LLC	accessdata.fda.gov
May 8, 2015	K150217	ORTHOPHOS SL	OAS	Substantially Equivalent	Sirona Dental Systems GmbH	accessdata.fda.gov
May 1, 2015	K143540	Stryker MIS Attachments and Cutting Accessories	HBE	Substantially Equivalent	Stryker Corporation	accessdata.fda.gov
April 3, 2015	K143053	KIMGUARD ONE-STEP Sterilization Wrap	FRG	Substantially Equivalent	Kimberly-Clark Health Care	accessdata.fda.gov
March 24, 2015	K143287	Fluidshield* Surgical Mask with Expanded Chamber	FXX	Substantially Equivalent	Halyard Health, Inc.	accessdata.fda.gov
February 10, 2015	K142716	VCARE	LKF	Substantially Equivalent	Conmed Corporation	accessdata.fda.gov
February 5, 2015	K143209	SonicFill 2	EBF	Substantially Equivalent	Sybron Dental Specialties	accessdata.fda.gov
September 12, 2014	K142134	C-WIRE DOUBLE ENDED ORTHOPEDIC WIRES	HTY	Substantially Equivalent	Conmed Corporation, Largo	accessdata.fda.gov
September 4, 2014	K141719	BIOGEL PL MICRO SURGICAL GLOVE	KGO	Substantially Equivalent	Molnlycke Health Care Us, LLC	accessdata.fda.gov
September 3, 2014	K141495	TRUWAVE DISPOSABLE PRESSURE TRANSDUCER	DXO	Substantially Equivalent	Edwards Lifesciences, LLC	accessdata.fda.gov
August 26, 2014	K141095	STRYKER STERI-SHIELD FLYTE HYBRID TOGAS	FYA	Substantially Equivalent	Stryker Corporation	accessdata.fda.gov
August 5, 2014	K141834	SAPPHIRE ADMINISTRATION SET	FPA	Substantially Equivalent	Q Core Medical , Ltd.	accessdata.fda.gov
July 25, 2014	K131720	HIVOX SELF ADHESIVE ELECTRODE GEL PADS	GXY	Substantially Equivalent	Hivox Biotek, Inc.	accessdata.fda.gov
July 18, 2014	K141625	POLYSYN SURGICAL SUTURE	GAM	Substantially Equivalent	Surgical Specialties Corp	accessdata.fda.gov
July 11, 2014	K141558	QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE	GAM	Substantially Equivalent	Surgical Specialties Corp	accessdata.fda.gov
July 10, 2014	K140658	THERMOGARD DISPERSIVE ELECTRODES, THERMOGARD PLUS ABC DISPERSIVE ELECTRODES	GEI	Substantially Equivalent	Conmed Corporation	accessdata.fda.gov
July 2, 2014	K140685	ENDO VAC APICAL NEGATIVE PRESSURE IRIGATION SYSTEM	NYL	Substantially Equivalent	Sybron Endo	accessdata.fda.gov
June 26, 2014	K140588	FLYTE HYBRID HOOD, FLYTE HYBRID HOOD WITH PEELAWAY LENS	FXY	Substantially Equivalent	Stryker Corporation	accessdata.fda.gov
May 21, 2014	K133428	MEDIKRO NANO, MEDIKRO PRIMO AND MEDIKRO PRO	BZG	Substantially Equivalent	Medikro OY	accessdata.fda.gov
May 8, 2014	K141081	FILTEK BULK FILL POSTERIOR RESTROATIVE	EBF	Substantially Equivalent	3M Espe Dental Products	accessdata.fda.gov
March 11, 2014	K132322	NEWTRON P5 XS B.LED	ELC	Substantially Equivalent	Satelec - Acteon Group	accessdata.fda.gov
March 3, 2014	K131402	VISICLEAR SMOKE EVACUATION SYSTEM	FYD	Substantially Equivalent	Buffalo Filter Co., Inc.	accessdata.fda.gov
February 21, 2014	K133948	BARD(R) MONOPTY(R) DISPOSABLE CORE BIOPSY INSTRUMENT, BARD(R) MAX-CORE(R) DISPOSABLE CORE INSTRUMENT	KNW	Substantially Equivalent	Bard Peripheral Vascular, Inc.	accessdata.fda.gov
February 12, 2014	K132464	PTFE SURGICAL SUTURE	NBY	Substantially Equivalent	Omnia Spa	accessdata.fda.gov
December 20, 2013	K132671	STRYKER NEPTUNE 2 WASTE MANAGMENT SYSTEM	JCX	Substantially Equivalent	Stryker Corporation	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
September 26, 2021	P200004	ConMed PadPro Multifunction Electrodes, ConMed PadPro Multifunction Electrode Adapters	MKJ	1	June 16, 2022	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 March 11, 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.