Data / Medical devices / Mexico / Convertors de Mexico S. de R.L. de C.V

Convertors de Mexico S. de R.L. de C.V: FDA-registered device maker in CD.JUAREZ Chihuahua, Mexico, 64 510(k) clearances

Name: Convertors de Mexico S. de R.L. de C.V FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Convertors de Mexico S. de R.L. de C.V is registered with the FDA (registration 9616088) in CD.JUAREZ Chihuahua, Mexico. It lists 390 device types. The FDA files 64 510(k) clearances under its listings, the newest dated December 11, 2018. Registered through 2026. FDA data exported November 3, 2026.

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Get makers like this one Watch Convertors de Mexico S. de R.L. de C.V

FDA registration number: 9616088
FEI number: 3002902735
Address: C. Arcadia 1580 Col. Terrazas Del Valle, CD.JUAREZ Chihuahua, Mexico, CP 32599
Owner or operator: Cardinal Health 200, LLC (9028292)
Roles: Manufacturer, Repackager or relabeler
First device listed: December 31, 1977
Registered through: 2026

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Catheter	KGZ	1	Repackager or relabeler	accessdata.fda.gov
Accessories, Cleaning Brushes, For Endoscope	MNL	1	Repackager or relabeler	accessdata.fda.gov
Accessory, Surgical Apparel	LYU	1	Repackager or relabeler	accessdata.fda.gov
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	DTL	2	Repackager or relabeler	accessdata.fda.gov
Admission Kit (Patient Utensil)	PWM	1	Manufacturer	accessdata.fda.gov
Airway Suction Kit	OFO	1	Manufacturer	accessdata.fda.gov
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	CCK	2	Repackager or relabeler	accessdata.fda.gov
Anesthesia Breathing Circuit Kit (Adult & Pediatric)	OFP	1	Manufacturer	accessdata.fda.gov
Anesthesia Kit	OFQ	2	Manufacturer	accessdata.fda.gov
Angiography/Angioplasty Kit	OEQ	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Angioscopic Valvulotome Kit	OER	2	Manufacturer	accessdata.fda.gov
Apparatus, Suction, Operating-Room, Wall Vacuum Powered	GCX	2	Repackager or relabeler	accessdata.fda.gov
Apparatus, Suction, Single Patient Use, Portable, Nonpowered	GCY	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Applicator, Absorbent Tipped, Non-Sterile	KXF	1	Repackager or relabeler	accessdata.fda.gov
Applier, Surgical, Clip	GDO	1	Repackager or relabeler	accessdata.fda.gov
Arterial Blood Sampling Kit	CBT	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Arthrogram Tray	OII	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Aspiration Tray	OJT	1	Manufacturer	accessdata.fda.gov
Balloon Gastrostomy Tube Kit	PRP	2	Manufacturer	accessdata.fda.gov
Band, Elastic, Orthodontic	ECI	1	Repackager or relabeler	accessdata.fda.gov
Bandage, Cast	ITG	1	Repackager or relabeler	accessdata.fda.gov
Bandage, Elastic	FQM	1	Repackager or relabeler	accessdata.fda.gov
Basic Set-Up Tray	PXN	1	Manufacturer	accessdata.fda.gov
Basin, Emesis	FNY	1	Repackager or relabeler	accessdata.fda.gov
Bedding, Disposable, Medical	KME	1	Repackager or relabeler	accessdata.fda.gov
Biopsy Needle Guide Kit	OIJ	2	Manufacturer	accessdata.fda.gov
Biopsy Needle Kit	POZ	2	Manufacturer	accessdata.fda.gov
Bladder Irrigation Kit	PPA	2	Manufacturer	accessdata.fda.gov
Blade, Saw, General & Plastic Surgery, Surgical	GFA	1	Repackager or relabeler	accessdata.fda.gov
Blade, Scalpel	GES	1	Repackager or relabeler	accessdata.fda.gov
Blood Administration Kit	PWO	2	Manufacturer	accessdata.fda.gov
Blood Alcohol Kit (Excludes Hiv Testing)	OIC	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Blood And Urine Collection Kit (Excludes Hiv Testing)	OIB	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Blood Specimen Collection Convenience Kit (Excludes Hiv)	PQD	2	Manufacturer	accessdata.fda.gov
Blood Specimen Collection Kit (Excludes Hiv Testing)	OFZ	1	Manufacturer	accessdata.fda.gov
Blood Transfusion Kit	POQ	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Body Fluid Clean Up Kit	OKG	2	Manufacturer	accessdata.fda.gov
Body Fluid Disposal Kit	OKF	2	Manufacturer	accessdata.fda.gov
Body Fluids Barrier Kit	OKH	2	Manufacturer	accessdata.fda.gov
Bone Marrow Biopsy Tray	PXO	1	Manufacturer	accessdata.fda.gov
Bone Marrow Collection/Transfusion Kit	LWE	2	Manufacturer	accessdata.fda.gov
Brachial Plexus Anesthesia Kit	OGA	2	Manufacturer	accessdata.fda.gov
Breast Biopsy / Localization Tray	PXP	1	Manufacturer	accessdata.fda.gov
Breast Pump Kit	OHH	2	Manufacturer	accessdata.fda.gov
Brush, Scrub, Operating-Room	GEC	1	Repackager or relabeler	accessdata.fda.gov
Burn Dressing Tray	PXQ	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Burn Kit Without Drug	OJJ	1	Manufacturer	accessdata.fda.gov
Camera, Surgical And Accessories	KQM	1	Repackager or relabeler	accessdata.fda.gov
Cannula, Ophthalmic	HMX	1	Repackager or relabeler	accessdata.fda.gov
Cardiac Catheterization Kit	OES	2	Manufacturer	accessdata.fda.gov
Cardioplegia Solution Administration Kit	OET	2	Manufacturer	accessdata.fda.gov
Cardiopulmonary Bypass Catheter Kit	OEU	2	Manufacturer	accessdata.fda.gov
Cardiopulmonary Resuscitation Aid Kit	OEV	2	Manufacturer	accessdata.fda.gov
Cardiovascular Catheter Sheath Introducer Kit	OEX	2	Manufacturer	accessdata.fda.gov
Cardiovascular Procedure Kit	OEZ	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Cardiovascular Surgical Instruments Tray	OFA	1	Manufacturer	accessdata.fda.gov
Catheter And Tip, Suction	JOL	2	Repackager or relabeler	accessdata.fda.gov
Catheter Care Tray	OHR	2	Manufacturer	accessdata.fda.gov
Catheter Guide Wire Kit	OFB	2	Manufacturer	accessdata.fda.gov
Catheter Introducer Kit	OFC	2	Manufacturer	accessdata.fda.gov
Catheter, Cholangiography	GBZ	1	Repackager or relabeler	accessdata.fda.gov
Catheter, Continuous Irrigation	GBQ	1	Repackager or relabeler	accessdata.fda.gov
Catheter, Coude	EZC	2	Repackager or relabeler	accessdata.fda.gov
Catheter, Intravascular, Diagnostic	DQO	2	Repackager or relabeler	accessdata.fda.gov
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	FOZ	2	Repackager or relabeler	accessdata.fda.gov
Catheter, Irrigation	GBX	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Catheter, Peritoneal	GBW	1	Repackager or relabeler	accessdata.fda.gov
Catheter, Retention Type, Balloon	EZL	2	Repackager or relabeler	accessdata.fda.gov
Catheter, Upper Urinary Tract	EYC	2	Repackager or relabeler	accessdata.fda.gov
Catheter, Urethral	GBM	2	Repackager or relabeler	accessdata.fda.gov
Catheter, Ventricular, General & Plastic Surgery	GBS	1	Repackager or relabeler	accessdata.fda.gov
Catheters, Suction, Tracheobronchial	BSY	1	Repackager or relabeler	accessdata.fda.gov
Caudal Anesthesia Kit	OGB	2	Manufacturer	accessdata.fda.gov
Central Venous Blood Pressure Kit	OFE	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Central Venous Catheter Dressing Change Kit	PEZ	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Central Venous Catheter Tray	OFF	2	Manufacturer	accessdata.fda.gov
Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use	JQC	1	Repackager or relabeler	accessdata.fda.gov
Cesarean Section Tray	OHM	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Chemotherapy Spill Clean-Up Kit	PWT	1	Manufacturer	accessdata.fda.gov
Chest Drainage Kit	PAD	2	Manufacturer	accessdata.fda.gov
Cholecystectomy Kit	PXS	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Circuit, Breathing (W Connector, Adaptor, Y Piece)	CAI	1	Repackager or relabeler	accessdata.fda.gov
Circumcision Tray	OHG	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Clamp	HXD	1	Repackager or relabeler	accessdata.fda.gov
Clamp, Circumcision	HFX	2	Repackager or relabeler	accessdata.fda.gov
Clamp, Surgical, General & Plastic Surgery	GDJ	1	Repackager or relabeler	accessdata.fda.gov
Clamp, Vascular	DXC	2	Repackager or relabeler	accessdata.fda.gov
Clean-Up Kit	PWU	1	Manufacturer	accessdata.fda.gov
Clip, Implantable	FZP	2	Repackager or relabeler	accessdata.fda.gov
Collector, Ostomy	EXB	1	Repackager or relabeler	accessdata.fda.gov
Collector, Urine, (And Accessories) For Indwelling Catheter	KNX	2	Repackager or relabeler	accessdata.fda.gov
Connector, Catheter	GCD	1	Repackager or relabeler	accessdata.fda.gov
Container, Liquid Medication, Graduated	KYW	1	Repackager or relabeler	accessdata.fda.gov
Container, Specimen Mailer And Storage, Sterile	KDT	1	Repackager or relabeler	accessdata.fda.gov
Container, Specimen, Non-Sterile	NNI	1	Repackager or relabeler	accessdata.fda.gov
Container, Specimen, Sterile	FMH	1	Repackager or relabeler	accessdata.fda.gov
Continuous Brachial Plexus Block Tray	OGC	2	Manufacturer	accessdata.fda.gov
Cotton, Roll	EFN	1	Repackager or relabeler	accessdata.fda.gov
Cover, Barrier, Protective	MMP	2	Repackager or relabeler	accessdata.fda.gov
Cover, Limb	IPM	1	Repackager or relabeler	accessdata.fda.gov
Cover, Shoe, Operating-Room	FXP	1	Repackager or relabeler	accessdata.fda.gov
Cricothyrotomy Kit	OGP	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Ct Biopsy Tray	OFG	2	Manufacturer	accessdata.fda.gov
Culdocentesis Kit	OHF	2	Manufacturer	accessdata.fda.gov
Curette, Uterine	HCY	1	Repackager or relabeler	accessdata.fda.gov
Custom Anesthesia Tray	OGD	2	Manufacturer	accessdata.fda.gov
Cutter, Surgical	FZT	1	Repackager or relabeler	accessdata.fda.gov
Cutter, Wire	HXZ	1	Repackager or relabeler	accessdata.fda.gov
Cytology Kit	OKY	2	Manufacturer	accessdata.fda.gov
D And C Tray	PKF	N	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Decontamination Kit	MAC	1	Manufacturer	accessdata.fda.gov
Dental Hygiene Kit	NXZ	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Dental Implant Surgical Tray	OFY	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Dental Prophylaxis Kit	NYC	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Denture Repair Kit	EBO	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Device, Intravascular Catheter Securement	KMK	1	Repackager or relabeler	accessdata.fda.gov
Device, Percutaneous, Biopsy	MJG	1	Repackager or relabeler	accessdata.fda.gov
Dialysis Administration Kit	PEV	2	Manufacturer	accessdata.fda.gov
Digital Angiography Tray	OFH	2	Manufacturer	accessdata.fda.gov
Dilator, Rectal	FFP	1	Repackager or relabeler	accessdata.fda.gov
Discography Kit	OIL	2	Manufacturer	accessdata.fda.gov
Dish, Tissue Culture	KIZ	1	Repackager or relabeler	accessdata.fda.gov
Dispenser, Liquid Medication	KYX	1	Repackager or relabeler	accessdata.fda.gov
Disposable Joint Aspiration/Injection Kit	PPP	1	Manufacturer	accessdata.fda.gov
Drape, Microscope, Ophthalmic	HMW	2	Repackager or relabeler	accessdata.fda.gov
Drape, Patient, Ophthalmic	HMT	2	Repackager or relabeler	accessdata.fda.gov
Drape, Pure Latex Sheet, With Self-Retaining Finger Cot	EYX	2	Repackager or relabeler	accessdata.fda.gov
Drape, Surgical, Antimicrobial	KKX	2	Repackager or relabeler	accessdata.fda.gov
Drape, Surgical, Ent	ERY	2	Manufacturer	accessdata.fda.gov
Drape, Surgical, Exempt	PUI	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Drape, Urological, Disposable	EYY	2	Repackager or relabeler	accessdata.fda.gov
Dressing Change Tray	OXQ	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Dressing, Compression	MHW	1	Repackager or relabeler	accessdata.fda.gov
Dressing, Wound, Drug	FRO	U	Repackager or relabeler	accessdata.fda.gov
Dressing, Wound, Hydrophilic	NAC	1	Repackager or relabeler	accessdata.fda.gov
Dressing, Wound, Occlusive	NAD	1	Repackager or relabeler	accessdata.fda.gov
Ear Irrigation Kit	OGQ	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Ear, Nose, And Throat Surgical Tray	OGR	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Electrosurgical Electrode Kit	NWI	2	Manufacturer	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Repackager or relabeler	accessdata.fda.gov
Emergency Obstetrical Kit	OKU	1	Manufacturer	accessdata.fda.gov
Emergency Response Safety Kit	OKI	2	Manufacturer	accessdata.fda.gov
Endodontic Kit	NYD	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Endometrial Sampling Kit	OKZ	2	Manufacturer	accessdata.fda.gov
Endoscope Introducer Kit	NWU	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Endoscopic Cholangiogram Kit	NWT	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Endoscopic Shunt Placement Kit	PVL	2	Manufacturer	accessdata.fda.gov
Endoscopic Ventricular Catheter Placement Kit	PVM	2	Manufacturer	accessdata.fda.gov
Endothelial Cell Harvesting Kit	MFY	2	Manufacturer	accessdata.fda.gov
Epidural Anesthesia Kit	OGE	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	LXG	1	Repackager or relabeler	accessdata.fda.gov
Esophageal Dilator Kit	PRQ	2	Manufacturer	accessdata.fda.gov
Eye Tray	OJK	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Feeding Tube Kit	PRR	2	Manufacturer	accessdata.fda.gov
Fetal Blood Sampling Kit (Excludes Hiv Testing)	PVS	2	Manufacturer	accessdata.fda.gov
Fiber, Medical, Absorbent	FRL	1	Repackager or relabeler	accessdata.fda.gov
First Aid Kit Without Drug	OHO	1	Manufacturer	accessdata.fda.gov
Fixture Mount Kit	NYE	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Fluid Drainage Tray	PXU	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Foley Catheter Kit (Excludes Hiv Testing)	PPB	2	Manufacturer	accessdata.fda.gov
Forceps	HTD	1	Repackager or relabeler	accessdata.fda.gov
Forceps, Biopsy, Gynecological	HFB	1	Repackager or relabeler	accessdata.fda.gov
Forceps, Ent	KAE	1	Repackager or relabeler	accessdata.fda.gov
Forceps, General & Plastic Surgery	GEN	1	Repackager or relabeler	accessdata.fda.gov
Forensic Evidence Sexual Assault Kit	OHE	2	Manufacturer	accessdata.fda.gov
Garment, Protective, For Incontinence	EYQ	1	Repackager or relabeler	accessdata.fda.gov
Gastric Irrigation And Aspiration Kit	PRT	2	Manufacturer	accessdata.fda.gov
Gastric Lavage Kit (Adult Or Pediatric Use)	PRU	2	Manufacturer	accessdata.fda.gov
Gastro-Urology Biopsy Kit	PRV	2	Manufacturer	accessdata.fda.gov
Gastrointestinal Tube Kit	PRW	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Gastrostomy Jejunostomy Feeding Tube Kit	PRY	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Gastrostomy Tube Kit	PRZ	2	Repackager or relabeler	accessdata.fda.gov
Gauze / Sponge,Nonresorbable For External Use	NAB	1	Repackager or relabeler	accessdata.fda.gov
Gauze/Sponge, Internal, X-Ray Detectable	GDY	1	Repackager or relabeler	accessdata.fda.gov
General Purpose Dental Tray	OFX	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
General Purpose Instrument Tray	PXV	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
General Surgery Tray	LRO	2	Manufacturer	accessdata.fda.gov
Gingival Retraction Kit	NYF	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Glossopharyngeal Anesthesia Kit	OGF	2	Manufacturer	accessdata.fda.gov
Gown, Surgical	FYA	2	Repackager or relabeler	accessdata.fda.gov
Guide, Needle, Surgical	GDF	1	Repackager or relabeler	accessdata.fda.gov
Guide, Surgical, Instrument	FZX	1	Repackager or relabeler	accessdata.fda.gov
Gynecological Laparoscopic Kit	OHD	2	Manufacturer	accessdata.fda.gov
Handle, Scalpel	GDZ	1	Repackager or relabeler	accessdata.fda.gov
Hemodialysis Tray (Not A Start/Stop Kit)	PPI	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Hemostat	HRQ	1	Repackager or relabeler	accessdata.fda.gov
Herniorraphy Kit	PXW	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Holder, Needle, Gastroenterologic	FHQ	1	Repackager or relabeler	accessdata.fda.gov
Holder, Needle; Orthopedic	HXK	1	Repackager or relabeler	accessdata.fda.gov
Hook, Surgical, General & Plastic Surgery	GDG	1	Repackager or relabeler	accessdata.fda.gov
Humidifier Nebulizer Kit	OGG	2	Manufacturer	accessdata.fda.gov
Hysterectomy Kit	OJF	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
I.V. Start Kit	LRS	2	Manufacturer	accessdata.fda.gov
Incision Tray	PXX	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Infant Heel Warmer (Chemical Heat Pack)	MPO	1	Repackager or relabeler	accessdata.fda.gov
Instrument, Manual, Surgical, General Use	MDM	1	Repackager or relabeler	accessdata.fda.gov
Instrument, Surgical, Disposable	KDC	1	Repackager or relabeler	accessdata.fda.gov
Instrument, Surgical, Non-Powered	HAO	1	Repackager or relabeler	accessdata.fda.gov
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	HWE	1	Repackager or relabeler	accessdata.fda.gov
Instruments, Surgical, Cardiovascular	DWS	1	Repackager or relabeler	accessdata.fda.gov
Insufflator, Laparoscopic	HIF	2	Repackager or relabeler	accessdata.fda.gov
Intracranial Pressure & Temperature Monitoring Kit	PSP	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Intravenous Extension Tubing Set	OJA	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Introducer, Catheter	DYB	2	Repackager or relabeler	accessdata.fda.gov
Irrigation Kit (Wounds)	PXY	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Kidney Perfusion Kit	PIN	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Kit, Cord Blood Collection	MYK	N	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Kit, Surgical Instrument, Disposable	KDD	1	Manufacturer	accessdata.fda.gov
LDQ	LDQ		Repackager or relabeler	accessdata.fda.gov
Labor And Delivery Kit	MLS	2	Manufacturer	accessdata.fda.gov
Laceration Tray	PKD	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Laparascopic Sphincterotomy Kit	PXZ	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Laparoscope, General & Plastic Surgery	GCJ	2	Repackager or relabeler	accessdata.fda.gov
Laparoscopic Bone Anchor Urethropexy Instrument Kit	NWN	2	Manufacturer	accessdata.fda.gov
Laparoscopic Cholecystectomy Kit	PKE	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Laparoscopic Gastrostomy Kit	PSD	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Laparoscopic Jejunostomy Kit	PSA	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Laparoscopy Kit	FDE	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Lapping Tool Kit	NYG	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Laryngoscope Kit	OGH	1	Manufacturer	accessdata.fda.gov
Laser Blood Flow Kit	OFI	2	Manufacturer	accessdata.fda.gov
Lead Introducer Kit	OFJ	2	Manufacturer	accessdata.fda.gov
Light, Surgical, Accessories	FTA	2	Repackager or relabeler	accessdata.fda.gov
Lubricant, Patient	KMJ	1	Repackager or relabeler	accessdata.fda.gov
Lumbar Drainage Catheter Kit	PVO	2	Manufacturer	accessdata.fda.gov
Lumbar Puncture Tray (Adult & Pediatric)	PWY	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Male External Catheterization Kit (Excludes Hiv Testing)	PPC	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Marker, Skin	FZZ	1	Repackager or relabeler	accessdata.fda.gov
Maternity Kit	PVT	1	Manufacturer	accessdata.fda.gov
Media, Coupling, Ultrasound	MUI	2	Repackager or relabeler	accessdata.fda.gov
Medical Glove, Specialty	LZC	1	Repackager or relabeler	accessdata.fda.gov
Mesh, Surgical, Polymeric	FTL	2	Repackager or relabeler	accessdata.fda.gov
Mid-Stream Collection Kit	PWZ	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Multi-Lumen Hemodialysis Catheterization Kit	PPO	2	Manufacturer	accessdata.fda.gov
Myringotomy Procedure Kit	OGS	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Nasal Endotracheal Tube Holder Kit	OGI	1	Manufacturer	accessdata.fda.gov
Nasogastric Feed Tube Kit	PSB	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Nasogastric-Gastrojejunal Kit	PSC	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Needle, Aspiration And Injection, Disposable	GAA	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Needle, Spinal, Short Term	MIA	2	Repackager or relabeler	accessdata.fda.gov
Neonatal Blood Collection Kit And Screening Form (Excludes Hiv Testing)	OIA	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Nephroscope Set	PPE	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Nerve Block Tray	OGJ	2	Manufacturer	accessdata.fda.gov
Neurological Test Kit	PVP	1	Manufacturer	accessdata.fda.gov
Neurological Tray	OJG	1	Manufacturer	accessdata.fda.gov
Non-Surgical Gown	OEA	1	Repackager or relabeler	accessdata.fda.gov
Obstetrical Anesthesia Kit	PVU	2	Manufacturer	accessdata.fda.gov
Obstetrical Kit	OKV	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Obstetrical Vacuum Delivery Kit	OHC	2	Manufacturer	accessdata.fda.gov
Operating Room Accessories Table Tray	FWZ	1	Repackager or relabeler	accessdata.fda.gov
Oral Irrigation Kit	OGT	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Oral Surgery Tray	PWL	1	Manufacturer	accessdata.fda.gov
Orotracheal Intubation Guide Kit	OGK	2	Manufacturer	accessdata.fda.gov
Orthopedic Tray	OJH	1	Manufacturer	accessdata.fda.gov
Ostomy Care Kit	PQE	1	Manufacturer	accessdata.fda.gov
Oxygen Administration Kit	OGL	2	Manufacturer	accessdata.fda.gov
Pack, Hot Or Cold, Disposable	IMD	1	Repackager or relabeler	accessdata.fda.gov
Pad, Alcohol, Device Disinfectant	LKB	U	Repackager or relabeler	accessdata.fda.gov
Pad, Menstrual, Unscented	HHD	1	Repackager or relabeler	accessdata.fda.gov
Pap Smear Kit	OHL	2	Manufacturer	accessdata.fda.gov
Paracentesis Tray	PYC	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Paracervical Anesthesia Kit	PVV	2	Manufacturer	accessdata.fda.gov
Parenteral Administration Kit	POR	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Pelvic Exam Kit	MLT	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Pelviscopy Kit	PYD	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Penile Implant Surgical Accessories	QGA	1	Repackager or relabeler	accessdata.fda.gov
Percutaneous Atrial Catheter Kit	OFK	2	Manufacturer	accessdata.fda.gov
Percutaneous Endoscopic Gastrostomy Kit	PSG	2	Manufacturer	accessdata.fda.gov
Percutaneous Introducer Kit	PXB	2	Manufacturer	accessdata.fda.gov
Percutaneous Sheath Introducer Kit	OFL	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Perineal Irrigation Kit	PSI	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Peripheral Catheter Insertion Kit	OWL	2	Manufacturer	accessdata.fda.gov
Peritoneal Dialysis Administration Kit	PPJ	2	Manufacturer	accessdata.fda.gov
Peritoneal Dialysis Tubing Kit	PPK	2	Manufacturer	accessdata.fda.gov
Personal Protection Kit	PXC	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Phlebotomy Blood Collection Kit	OFM	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Pierced Ear/Entry Cleaning Tray	OGU	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Plaque Disclosing Kit	NYH	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Port Introducer Kit	OKE	2	Manufacturer	accessdata.fda.gov
Prep Kit	PXD	1	Manufacturer	accessdata.fda.gov
Probe	HXB	1	Repackager or relabeler	accessdata.fda.gov
Probe And Director, Gastro-Urology	FGM	1	Repackager or relabeler	accessdata.fda.gov
Prostate Seeding Kit	OIN	2	Manufacturer	accessdata.fda.gov
Protector, Skin Pressure	FMP	1	Repackager or relabeler	accessdata.fda.gov
Pudendal Anesthesia Kit	PVW	2	Manufacturer	accessdata.fda.gov
Radiographic Contrast Tray	OIO	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Radiology-Diagnostic Kit	OIP	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Razor, Surgical	LWK	1	Repackager or relabeler	accessdata.fda.gov
Rectal Dilator Kit	PSJ	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Regional Anesthesia Kit	OFV	2	Manufacturer	accessdata.fda.gov
Replacement Gastrostomy Feeding Catheter Tray	PSK	2	Manufacturer	accessdata.fda.gov
Restorative Instrument And Component Tray	OFW	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Retractor	GAD	1	Repackager or relabeler	accessdata.fda.gov
Ring (Wound Protector), Drape Retention, Internal	KGW	2	Repackager or relabeler	accessdata.fda.gov
Sampler, Amniotic Fluid (Amniocentesis Tray)	HIO	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Scissors, General, Surgical	LRW	1	Repackager or relabeler	accessdata.fda.gov
Scissors, Medical, Disposable	JOK	1	Repackager or relabeler	accessdata.fda.gov
Scissors, Ophthalmic	HNF	1	Repackager or relabeler	accessdata.fda.gov
Scissors, Wire Cutting, Ent, Sterile	JYA	1	Repackager or relabeler	accessdata.fda.gov
Seminal Fluid Collection Kit	OKW	2	Manufacturer	accessdata.fda.gov
Set, Administration, Intravascular	FPA	2	Repackager or relabeler	accessdata.fda.gov
Sex Crimes / Sexual Assault / Suspect Evidence Collection Kit (Excludes Hiv Testing)	OID	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Shave Prep Kit	OJW	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Single Needle (Co-Axial Flow) Dialysis Kit	PPL	2	Manufacturer	accessdata.fda.gov
Single Needle With Uni-Directional Pump Kit	PPH	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Single Use Instrument Tray	OJV	1	Manufacturer	accessdata.fda.gov
Sitz Bath Kit	PXF	1	Manufacturer	accessdata.fda.gov
Skin Prep Tray	OJU	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Sleeve, Limb, Compressible	JOW	2	Manufacturer	accessdata.fda.gov
Snake Bite Suction Kit	KYP	1	Manufacturer	accessdata.fda.gov
Specula, Ophthalmic	HNC	1	Repackager or relabeler	accessdata.fda.gov
Speculum, Vaginal, Metal	HDF	1	Repackager or relabeler	accessdata.fda.gov
Speculum, Vaginal, Nonmetal	HIB	2	Repackager or relabeler	accessdata.fda.gov
Spill Kit	PXG	1	Manufacturer	accessdata.fda.gov
Spinal Anesthesia Kit	OFU	2	Manufacturer	accessdata.fda.gov
Spinal Epidural Anesthesia Kit	OFT	2	Manufacturer	accessdata.fda.gov
Staple Removal Kit	PYE	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Staple, Removable (Skin)	GDT	1	Repackager or relabeler	accessdata.fda.gov
Sterile Puncture Tray	PYF	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Stopcock, I.V. Set	FMG	2	Repackager or relabeler	accessdata.fda.gov
Suction Catheter Kit	PYG	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Support, Patient Position	CCX	1	Repackager or relabeler	accessdata.fda.gov
Suprapubic Cystostomy Catheter Kit	NWP	2	Manufacturer	accessdata.fda.gov
Surgeon'S Gloves	KGO	1	Repackager or relabeler	accessdata.fda.gov
Surgical Cannulaes & Depth Gauge Kit For Arthroscopic Procedures	PPR	2	Manufacturer	accessdata.fda.gov
Surgical Eye Tray	PZG	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Surgical Instruments, G-U, Manual (And Accessories)	KOA	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Surgical Retractor Kit	PYH	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Suture Kit	OVN	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Suture Removal Kit	MCZ	1	Manufacturer	accessdata.fda.gov
Suture, Absorbable, Natural	GAL	2	Repackager or relabeler	accessdata.fda.gov
Suture, Absorbable, Synthetic, Polyglycolic Acid	GAM	2	Repackager or relabeler	accessdata.fda.gov
Suture, Nonabsorbable	GAO	2	Repackager or relabeler	accessdata.fda.gov
Suture, Nonabsorbable, Silk	GAP	2	Repackager or relabeler	accessdata.fda.gov
Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile	GAQ	2	Repackager or relabeler	accessdata.fda.gov
Suture, Nonabsorbable, Synthetic, Polyamide	GAR	2	Repackager or relabeler	accessdata.fda.gov
Suture, Nonabsorbable, Synthetic, Polyethylene	GAT	2	Repackager or relabeler	accessdata.fda.gov
Suture, Nonabsorbable, Synthetic, Polypropylene	GAW	2	Repackager or relabeler	accessdata.fda.gov
Syringe, Irrigating (Non Dental)	KYZ	1	Repackager or relabeler	accessdata.fda.gov
Syringe, Piston	FMF	2	Repackager or relabeler	accessdata.fda.gov
System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile	EYZ	1	Repackager or relabeler	accessdata.fda.gov
Table And Attachments, Operating-Room	BWN	1	Repackager or relabeler	accessdata.fda.gov
Table, Surgical With Orthopedic Accessories, Manual	JEB	1	Repackager or relabeler	accessdata.fda.gov
Tape And Bandage, Adhesive	KGX	1	Repackager or relabeler	accessdata.fda.gov
Tape, Measuring, Rulers And Calipers	FTY	1	Repackager or relabeler	accessdata.fda.gov
Thermometer, Clinical Mercury	FLK	2	Repackager or relabeler	accessdata.fda.gov
Thoracentesis Tray	PXI	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Thoracic Catheter Insertion Tray	PYI	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Tissue Processing Kit	PFU	N	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Toothbrush, Manual	EFW	1	Repackager or relabeler	accessdata.fda.gov
Tourniquet Kit	OJS	1	Manufacturer	accessdata.fda.gov
Tourniquet, Nonpneumatic	GAX	1	Repackager or relabeler	accessdata.fda.gov
Tracheal Suction Set	OFS	1	Manufacturer	accessdata.fda.gov
Tracheobronchial Suction Catheter Kit	OFR	1	Manufacturer	accessdata.fda.gov
Tracheostomy And Nasal Suctioning Kit	LRQ	1	Manufacturer	accessdata.fda.gov
Tracheostomy Cleaning Tray	OGV	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Tracheostomy Kit	OGW	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Tracheotomy Care Kit	NXA	2	Manufacturer	accessdata.fda.gov
Transducer, Blood-Pressure, Extravascular	DRS	2	Repackager or relabeler	accessdata.fda.gov
Transtibial Anterior Cruciate Ligament Kit	PPQ	2	Manufacturer	accessdata.fda.gov
Tray, Start/Stop (Including Contents), Dialysis	FKG	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Tray, Surgical	LRP	1	Manufacturer	accessdata.fda.gov
Tray, Surgical, Instrument	FSM	1	Repackager or relabeler	accessdata.fda.gov
Trocar	DRC	2	Repackager or relabeler	accessdata.fda.gov
Trocar Kit	OKX	2	Manufacturer	accessdata.fda.gov
Tube, Double Lumen For Intestinal Decompression And/Or Intubation	FEG	2	Repackager or relabeler	accessdata.fda.gov
Tube, Tissue Culture	KJG	1	Repackager or relabeler	accessdata.fda.gov
Tubes, Gastrointestinal (And Accessories)	KNT	2	Repackager or relabeler	accessdata.fda.gov
Tubes, Vacuum Sample, With Anticoagulant	GIM	2	Repackager or relabeler	accessdata.fda.gov
Tubing, Noninvasive	GAZ	2	Repackager or relabeler	accessdata.fda.gov
Tubing, Pressure And Accessories	BYX	1	Repackager or relabeler	accessdata.fda.gov
Ulcer Wound Tray	PYJ	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Umbilical Catheter Insertion Tray	PXJ	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Universal Drainage Tray	PPD	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Urinary Drainage Collection Kit	PPG	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Urinary Drainage Collection Kit, For Indwelling Catheter	FCN	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Urinary Irrigation Kit	PPF	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Urine Collection Kit (Excludes Hiv Testing)	OIE	1	Manufacturer	accessdata.fda.gov
Urine Transport Kit (Excludes Hiv Testing)	OHZ	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Vacuum Powered Body Fluid Collection Kit	OJR	2	Manufacturer	accessdata.fda.gov
Vaginal Examination Tray	PVX	2	Manufacturer	accessdata.fda.gov
Vascular Access Port Kit	PXK	2	Manufacturer	accessdata.fda.gov
Vasovasostomy Set	PVY	1	Manufacturer	accessdata.fda.gov
Venous Ulcer Kit	PYK	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Vomitus Clean-Up Kit	PXM	1	Manufacturer	accessdata.fda.gov
Winged Intravenous Catheterization Kit	OFN	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Wire, Guide, Catheter	DQX	2	Repackager or relabeler	accessdata.fda.gov
Wound Drainage Kit	PYL	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Wound Dressing Kit	MCY	2	Manufacturer	accessdata.fda.gov
Wrap, Sterilization	FRG	2	Repackager or relabeler	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.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
December 11, 2018	K181174	Cardinal Health Sterilization Wrap	FRG	Substantially Equivalent	Cardinal Health200, LLC	accessdata.fda.gov
June 13, 2018	K181363	EcoVue Sterile and Non-Sterile Ultrasound Gels	MUI	Substantially Equivalent	H R Pharmaceuticals, Inc.	accessdata.fda.gov
January 31, 2018	K173601	Merit Syringe	FMF	Substantially Equivalent	Merit Medical Systems, Inc.	accessdata.fda.gov
December 6, 2013	K133356	PROLENE POLYPROPYLENE NONABSORBABLE SUTURE	GAW	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
June 8, 2011	K110272	STERILE POLYISOPRENE POWDER-FREE SURGICAL GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUG	KGO	Substantially Equivalent	Cardinal Health, Inc.	accessdata.fda.gov
May 4, 2010	K100306	KENDALL SCD SEQUENTIAL COMPRESSION COMFORT SLEEVES	JOW	Substantially Equivalent	Covidien	accessdata.fda.gov
September 23, 2009	K091060	VESOCCLUDE LIGATING CLIP	FZP	Substantially Equivalent	Vesocclude Medical, LLC	accessdata.fda.gov
May 18, 2007	K070964	KLEENSPEC SINGLE USE VAGINAL SPECULUM AND 790 SERIES CORDLESS ILLUMINATION SYSTEM	HIB	Substantially Equivalent	Welch Allyn, Inc.	accessdata.fda.gov
April 9, 2004	K040052	FINE SURGICAL CIRCUMCISION CLAMP	HFX	Substantially Equivalent	Fine Surgical Instrument Corp.	accessdata.fda.gov
March 7, 2003	K030339	CAUTERY TIP CLEANER, MODEL-TC-100	GEI	Substantially Equivalent	Aspen Surgical Products, Inc.	accessdata.fda.gov
October 2, 2002	K023167	BREATHABLE SURGICAL GOWN	FYA	Substantially Equivalent	Allegiance Healthcare Corp.	accessdata.fda.gov
July 3, 2002	K021094	INTROCAN SAFETY IV CATHETER	DYB	Substantially Equivalent	B.Braun Medical, Inc.	accessdata.fda.gov
March 18, 2002	K020593	CONVERTORS SMS POLYOLEFIN GOWN	FYA	Substantially Equivalent	Allegiance Healthcare Corp.	accessdata.fda.gov
February 19, 2002	K014239	MEDSURG EQUIPMENT COVERS	MMP	Substantially Equivalent	International Medsurg Connection	accessdata.fda.gov
July 14, 2000	K001924	COATED STERILE LATEX POWDEER-FREE SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM OR LESS0	KGO	Substantially Equivalent	Allegiance Healthcare Corp.	accessdata.fda.gov
January 20, 2000	K992436	GOWN BACK, MODEL 13-403N; 13-404N; 13-405N	FYA	Substantially Equivalent	Techstyles	accessdata.fda.gov
January 4, 2000	K993463	INTRAVASCULAR ADMINISTRATION SET	FPA	Substantially Equivalent	Custom Assemblies, Inc.	accessdata.fda.gov
December 9, 1999	K993063	RUSCH BRILLANT SILICONE FOLEY	EZL	Substantially Equivalent	Rusch Intl.	accessdata.fda.gov
September 14, 1999	K992171	COATED STERILE LATEX POWDER-FREE SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)	KGO	Substantially Equivalent	Allegiance Healthcare Corp.	accessdata.fda.gov
July 23, 1998	K982269	CLEAR HUB SPINAL NEEDLE 14GA, 16GA, 17GA, 18GA, 20GA, 21GA, 22GA, 25GA, 26GA AND 27GA	MIA	Substantially Equivalent	Allegiance Healthcare Corp.	accessdata.fda.gov
July 9, 1998	K981956	DEGANIA SILICONE IDENTI LOOPS	DXC	Substantially Equivalent	Degania Silicone , Ltd.	accessdata.fda.gov
December 24, 1997	K971339	INSYTE, INSYTE-W, INSYTE AUTOGUARD CATHETERS	FOZ	Substantially Equivalent	Becton Dickinson Vascular Access, Inc.	accessdata.fda.gov
December 15, 1997	K973507	KENDALL XEROFORM PETROLATUM DRESSING (6311,6312,6313,6314,6315,6316,6317)	FRO	Substantially Equivalent for Some Indications	Kendall Healthcare Products Co. Div.Of Tyco Health	accessdata.fda.gov
September 19, 1997	K972901	AMERICAN BIOSURGICAL ELECTROSURGICAL BIPOLAR CABLE/CORD	GEI	Substantially Equivalent	American Biosurgical, Inc.	accessdata.fda.gov
July 1, 1997	K971472	SIL-TEC NONREINFORCED SHEETING, REINFORCED SHEETING, RADIOPAQUE SHEETING, REINFORCED RADIOPAQUE SHEETING, EXTRA FIRM GRA	FTL	Substantially Equivalent	Technical Products, Inc.	accessdata.fda.gov
June 24, 1997	K970855	CLAVE CONNECTOR	FPA	Substantially Equivalent	Icu Medical, Inc.	accessdata.fda.gov
June 17, 1997	K971449	VACUTAINER BRAND PLUS TUBE WITH EDTA ANTICOAGULANT(MULTIPLE)	GIM	Substantially Equivalent	Becton Dickinson Vacutainer Systems	accessdata.fda.gov
April 2, 1997	K964435	PRIMARY IV SET	FMG	Substantially Equivalent	Icu Medical, Inc.	accessdata.fda.gov
June 6, 1996	K961154	BAXTER SODIUM ACETATE INFANT HEEL WARMER	MPO	Substantially Equivalent	Baxter Healthcare Corp	accessdata.fda.gov
March 25, 1996	K951722	PERCEPTOR COMPENSATOR MORSE MANIFOLD	DRS	Substantially Equivalent	Namic	accessdata.fda.gov
March 12, 1996	K955785	TS PERCUTANEOUS ARTERIAL/VENUS CATHETER INTRO SET	DYB	Substantially Equivalent	C.R. Bard, Inc.	accessdata.fda.gov
December 20, 1995	K954853	AUTO SUTURE SUTURE CLOSURE	GCJ	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc	accessdata.fda.gov
October 18, 1995	K953889	AMERICAN BIOSURGICAL ELECTROSURGICAL BIPOLAR CABLE/CORD	GEI	Substantially Equivalent	American Biosurgical, Inc.	accessdata.fda.gov
July 31, 1995	K952861	ANGIOCATH & INSYTE AUTOGUARD CATHETERS	FOZ	Substantially Equivalent	Becton Dickinson Vascular Access, Inc.	accessdata.fda.gov
May 25, 1995	K952204	CONMED/ASPEN LABS COATED LAPAROSCOPIC ELECTROSURGICAL BLADES	GEI	Substantially Equivalent	Conmedcorp	accessdata.fda.gov
April 18, 1995	K950301	ANGIOCATH(R) NONVALON(R) AND ANGIO-SET(R) IV CATHETERS	FOZ	Substantially Equivalent	Becton Dickinson Vascular Access, Inc.	accessdata.fda.gov
February 10, 1995	K943897	NU-SITE	FPA	Substantially Equivalent	Medex, Inc.	accessdata.fda.gov
January 9, 1995	K946173	STAINLESS STEEL, GUT, POLY (GLYCOLIDE/L-LACTIDE) POLYAMIDE, POLYPROPYLENE, POLY (ETHYLENE TEREPHTHALATE) AND SILK	GAQ	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
February 22, 1994	K932512	MULTI-PORT MANIFOLD	FMG	Substantially Equivalent	Baxter Healthcare Corp	accessdata.fda.gov
February 17, 1994	K935086	AUTO SUTURE DISPOSABLE OPTICAL TROCAR	GCJ	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc	accessdata.fda.gov
January 7, 1994	K932513	LABELING FOR MYO/WIRE II STERNOTOMY SUTURES	GAO	Substantially Equivalent	Alto Development Corp.	accessdata.fda.gov
November 3, 1993	K933700	DYE MANAGEMENT SYSTEM	DQO	Substantially Equivalent	Abbott Laboratories	accessdata.fda.gov
July 13, 1993	K926217	TERUMO ANGIOGRAPHIC CATHETER FOR LAPOROSCOPIC USE	GBZ	Substantially Equivalent	Terumo Medical Corp.	accessdata.fda.gov
May 17, 1993	K925790	EXAC-TEMP & CLINI-TEMP FOLEY CATHETER'S	EYC	Substantially Equivalent	Deroyal Industries, Inc.	accessdata.fda.gov
July 13, 1992	K920959	INSUFFLATOR, LAPAROSCOPIC	HIF	Substantially Equivalent	Mectra Labs, Inc.	accessdata.fda.gov
November 15, 1991	K913682	MERIT CUSTOM KIT	DQO	Substantially Equivalent	Merit Medical Systems, Inc.	accessdata.fda.gov
August 16, 1991	K910846	BARD LATEX URINARY CATHETERS DRAINS- DESIGNS MODIF	EZC	Unknown	C.R. Bard, Inc.	accessdata.fda.gov
September 12, 1989	K890959	GUIDEWIRE	DQX	Substantially Equivalent	Guidewire Technologies, Inc.	accessdata.fda.gov
July 24, 1989	K892406	MODIFIED OXYGEN DELIVERY/CO2 SAMPLE NASAL CANNULA	CCK	Substantially Equivalent	Salter Labs	accessdata.fda.gov
November 25, 1988	K884656	DISPOSABLE BIPOLAR CORD AND BIPOLAR FORCEP	GEI	Substantially Equivalent	Dermacare	accessdata.fda.gov
November 5, 1986	K864102	LIGACLIP 20/20* MULTIPLE CLIP APPLIER	FZP	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
February 4, 1984	K834062	STERILE LABELS	LDQ	Substantially Equivalent	Devon Industries, Inc.	accessdata.fda.gov
October 27, 1983	K833184	APLICARE THREE ALCOHOL SWABSTICKS	LKB	Substantially Equivalent	Aplicare, Inc.	accessdata.fda.gov
June 2, 1983	K831236	BIPOLAR CARD	GEI	Substantially Equivalent	New England Surgical Instrument Corp.	accessdata.fda.gov
July 13, 1982	K821906	CORPAK ENTERIC FEEDING TUBE W/GUIDE TIP	KNT	Substantially Equivalent	Corpak Medsystems	accessdata.fda.gov
July 28, 1980	K801421	TUBE HOLDER	LDQ	Substantially Equivalent	Devon Industries, Inc.	accessdata.fda.gov
December 18, 1979	K792357	STERILE IMPERVIOUS ORTHOPEDIC STOCKIN	KKX	Substantially Equivalent	Alba-Waldensian, Inc.	accessdata.fda.gov
June 22, 1979	K791098	SINGLE-USE MINI-BULLDOG	DXC	Substantially Equivalent	Med General	accessdata.fda.gov
January 23, 1979	K782095	STOPCOCKS, MANIFOLDS	DTL	Substantially Equivalent	Namic	accessdata.fda.gov
September 2, 1977	K770933	BIO-SHIELD CSR WRAP	FRG	Substantially Equivalent	Convertors	accessdata.fda.gov
July 19, 1977	K771048	CATHETERS, DRAINAGE	FEG	Substantially Equivalent	Axiom Medical, Inc.	accessdata.fda.gov
June 29, 1977	K771055	BLOOD COLLECTION TUBE, RED	GIM	Substantially Equivalent	Sherwood Medical Industries	accessdata.fda.gov
June 27, 1977	K771052	BLOOD COLLECTION TUBE, LAVENDER	GIM	Substantially Equivalent	Sherwood Medical Industries	accessdata.fda.gov
June 14, 1977	K770977	CARDIOVASCULAR SPRING GUIDES	DQX	Substantially Equivalent	Lake Region Mfg., Inc.	accessdata.fda.gov

Compare with other makers

Updated December 11, 2018. 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.