Data / Medical devices / United Kingdom / Veenak International Limited

Veenak International Limited: FDA-registered device maker in Birmingham, United Kingdom, 121 510(k) clearances

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

Veenak International Limited is registered with the FDA (registration 3013298431) in Birmingham, United Kingdom. It lists 162 device types. The FDA files 121 510(k) clearances under its listings, the newest dated November 1, 2024. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3013298431
Address: 1406 Coventry Road South Yardley, Birmingham, United Kingdom, B25 8AE
Owner or operator: VEENAK INTERNATIONAL LIMITED (10058153)
Roles: Exporter to the US
First device listed: September 10, 2018
Registered through: 2026
Brand names listed: ELASTOMER, SILICONE, FOR SCAR MANAGEMENT

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Catheter	KGZ	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
Adaptor, Hygiene	ILS	1	Exporter to the US	accessdata.fda.gov
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	DTL	2	Exporter to the US	accessdata.fda.gov
Airway, Oropharyngeal, Anesthesiology	CAE	1	Exporter to the US	accessdata.fda.gov
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	CCK	2	Exporter to the US	accessdata.fda.gov
Anoscope And Accessories	FER	2	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
Arthroscope	HRX	2	Exporter to the US	accessdata.fda.gov
Bag, Drainage, With Adhesive, Ostomy	FON	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
Basin, Emesis	FNY	1	Exporter to the US	accessdata.fda.gov
Bedding, Disposable, Medical	KME	1	Exporter to the US	accessdata.fda.gov
Bedpan	FOB	1	Exporter to the US	accessdata.fda.gov
Blood Pressure Cuff	DXQ	2	Exporter to the US	accessdata.fda.gov
Bronchoscope (Flexible Or Rigid)	EOQ	2	Exporter to the US	accessdata.fda.gov
Bulb, Inflation, For Endoscope	FCY	1	Exporter to the US	accessdata.fda.gov
Calculator/Data Processing Module, For Clinical Use	JQP	1	Exporter to the US	accessdata.fda.gov
Calibrator, Volume, Gas	BXW	1	Exporter to the US	accessdata.fda.gov
Cap, Surgical	FYF	1	Exporter to the US	accessdata.fda.gov
Catheter And Tip, Suction	JOL	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, Retention Type, Balloon	EZL	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
Circuit, Breathing (W Connector, Adaptor, Y Piece)	CAI	1	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
Connector, Airway (Extension)	BZA	1	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, 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
Counter, Sponge, Surgical	LWH	1	Exporter to the US	accessdata.fda.gov
Cover, Mattress (Medical Purposes)	FMW	1	Exporter to the US	accessdata.fda.gov
Cover, Shoe, Operating-Room	FXP	1	Exporter to the US	accessdata.fda.gov
Cream, Gloving, Surgeon'S	KGQ	1	Exporter to the US	accessdata.fda.gov
Crown, Preformed	ELZ	1	Exporter to the US	accessdata.fda.gov
Depressor, Tongue, Non-Surgical	FMA	1	Exporter to the US	accessdata.fda.gov
Device, Fixation, Tracheal Tube	CBH	1	Exporter to the US	accessdata.fda.gov
Device, Intravascular Catheter Securement	KMK	1	Exporter to the US	accessdata.fda.gov
Device, Occlusion, Umbilical	FOD	1	Exporter to the US	accessdata.fda.gov
Device, Transfer, Patient, Manual	FMR	1	Exporter to the US	accessdata.fda.gov
Disinfectant, Medical Devices	LRJ	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
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, 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, Bone, Powered	DZI	2	Exporter to the US	accessdata.fda.gov
Elastomer, Silicone, For Scar Management	MDA	1	Exporter to the US	accessdata.fda.gov
Electrocardiograph	DPS	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, 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
Enteral Syringes With Enteral Specific Connectors	PNR	2	Exporter to the US	accessdata.fda.gov
Esthesiometer	GXB	1	Exporter to the US	accessdata.fda.gov
Exophthalmometer	HLS	1	Exporter to the US	accessdata.fda.gov
Forceps, General & Plastic Surgery	GEN	1	Exporter to the US	accessdata.fda.gov
Garment, Protective, For Incontinence	EYQ	1	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
General Surgery Tray	LRO	2	Exporter to the US	accessdata.fda.gov
Glucose Dehydrogenase, Glucose	LFR	2	Exporter to the US	accessdata.fda.gov
Gown, Surgical	FYA	2	Exporter to the US	accessdata.fda.gov
Holder, Ureteral Catheter	EYJ	1	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
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
Kit, Surgical Instrument, Disposable	KDD	1	Exporter to the US	accessdata.fda.gov
Lubricant, Patient	KMJ	1	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
Medical Glove, Specialty	LZC	1	Exporter to the US	accessdata.fda.gov
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	MWI	2	Exporter to the US	accessdata.fda.gov
Multiple Use Blood Lancet For Single Patient Use Only	QRL	2	Exporter to the US	accessdata.fda.gov
Nasopharyngoscope (Flexible Or Rigid)	EOB	2	Exporter to the US	accessdata.fda.gov
Needle, Aspiration And Injection, Disposable	GAA	1	Exporter to the US	accessdata.fda.gov
Needle, Conduction, Anesthetic (W/Wo Introducer)	BSP	2	Exporter to the US	accessdata.fda.gov
Needle, Hypodermic, Single Lumen	FMI	2	Exporter to the US	accessdata.fda.gov
Neurosurgical Paddie	HBA	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
Otoscope	ERA	1	Exporter to the US	accessdata.fda.gov
Oximeter	DQA	2	Exporter to the US	accessdata.fda.gov
Pack, Hot Or Cold, Disposable	IMD	1	Exporter to the US	accessdata.fda.gov
Pad, Eye	HMP	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
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
Pouch, Colostomy	EZQ	1	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
Pump, Portable, Aspiration (Manual Or Powered)	BTA	2	Exporter to the US	accessdata.fda.gov
Purifier, Water (Absorption, Deionization, Membrane Filter, Reverse Osmosis)	JRS	1	Exporter to the US	accessdata.fda.gov
Razor, Surgical	LWK	1	Exporter to the US	accessdata.fda.gov
Retinoscope, Battery-Powered	HKM	1	Exporter to the US	accessdata.fda.gov
Scaler, Ultrasonic	ELC	2	Exporter to the US	accessdata.fda.gov
Scissors, Medical, Disposable	JOK	1	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
Sigmoidoscope And Accessories, Flexible/Rigid	FAM	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
Stand, Infusion	FOX	1	Exporter to the US	accessdata.fda.gov
Stand, Instrument, Ac-Powered, Ophthalmic	HMF	1	Exporter to the US	accessdata.fda.gov
Staple, Removable (Skin)	GDT	1	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
Support, Patient Position	CCX	1	Exporter to the US	accessdata.fda.gov
Surgeon'S Gloves	KGO	1	Exporter to the US	accessdata.fda.gov
Surgical Instruments, G-U, Manual (And Accessories)	KOA	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
Syringe, Antistick	MEG	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
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, Blood Glucose, Over The Counter	NBW	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
Tape, Measuring, Rulers And Calipers	FTY	1	Exporter to the US	accessdata.fda.gov
Test, Time, Prothrombin	GJS	2	Exporter to the US	accessdata.fda.gov
Tester, Auditory Impedance	ETY	2	Exporter to the US	accessdata.fda.gov
Trap, Sterile Specimen	BYZ	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, Tracheostomy (W/Wo Connector)	BTO	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, Pressure And Accessories	BYX	1	Exporter to the US	accessdata.fda.gov
Unit, Oral Irrigation	EFS	1	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 121.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
November 1, 2024	K242320	BD Vacutainer® One Use Holder	JKA	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
June 3, 2022	K220633	MICROLET NEXT lancing device, MICROLET Lancet	QRL	Substantially Equivalent	Ascensia Diabetes Care U.S., Inc.	accessdata.fda.gov
May 24, 2022	K213481	Medline General Surgery Tray	LRO	Substantially Equivalent	Medline Industries, Inc.	accessdata.fda.gov
January 14, 2022	K212093	Medline Universal Grounding Pad	GEI	Substantially Equivalent	Medline Industries, Inc.	accessdata.fda.gov
September 30, 2021	K203609	Intravascular Administration Sets	FPA	Substantially Equivalent	Baxter Healthcare Corporation	accessdata.fda.gov
June 17, 2021	K210883	aScope 4 Broncho Regular Sampler Set 5.0/2.2, aScope 4 Broncho Large Sampler Set 5.8/2.8	EOQ	Substantially Equivalent	Ambu A/S	accessdata.fda.gov
March 12, 2021	K210526	Medline Cautery Tip Cleaner	GEI	Substantially Equivalent	Medline Industries, Inc.	accessdata.fda.gov
October 21, 2020	K201155	PleurX Peritoneal Catheter System	PNG	Unknown	Care Fusion	accessdata.fda.gov
October 9, 2020	K202285	Medline ENfit OTC Feeding Syringe	PNR	Substantially Equivalent	Medline Industries, Inc.	accessdata.fda.gov
April 6, 2020	K193217	SensiCare PI and SensiCare PI Micro Surgical Gloves	KGO	Substantially Equivalent	Medline Industries, Inc.	accessdata.fda.gov
March 6, 2020	K191915	SensiCare Sterile Power-Free Polymer Coated Polyisoprene Sugical Glove, Coated with Aloe V	KGO	Substantially Equivalent	Medline Industries, Inc.	accessdata.fda.gov
February 28, 2020	K192820	SensiCare Neoprene Synthetic Polychloroprene Surgical Glove (Tested for Use with Chemotherapy Drugs)	KGO	Substantially Equivalent	Medline Industries, Inc.	accessdata.fda.gov
December 4, 2019	K191759	Medline Quick Switch Valve with ENFit Connector	PIF	Substantially Equivalent	Medline Industries, Inc.	accessdata.fda.gov
July 4, 2019	K190950	Medline Level 2 Surgical Gown (Eclipse Non-Reinforced), Medline Level 3 Surgical Gown (Eclipse Fabric Reinforced), Medline Level 3 Surgical Gown (Sirus Non-Reinforced), Medline Level 3 Surgical Gown (Sirus Fabric Reinforced), Medline Level 3 Surgical Gown (Aurora Non Reinforced & Aurora Fabric Reinforced)	FYA	Substantially Equivalent	Medline Industries, Inc.	accessdata.fda.gov
May 22, 2019	K191080	Ambu aScope 4 RhinoLaryngo Slim	EOB	Substantially Equivalent	Ambu A/S	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
April 30, 2018	K180696	Medline Green Ambidextrous Powder-Free Nitrile Examination Gloves with Colloidal Oatmeal (Tested for use with Chemotherapy Drugs)	LZA	Substantially Equivalent	Medline Industries, 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
January 17, 2018	K173113	Medline Disposable Electronic Thermometer Probe Cover	FLL	Substantially Equivalent	Medline Industries, Inc.	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
November 1, 2017	K162812	Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous Infusion Set, Unomedical Neria Soft Subcutaneous Infusion Set, Medtronic Silhouette Subcutaneous Infusion Set, Medtronic Silhouette Paradigm Subcutaneous Infusion Set, Roche Accu-Chek Tender Subcutaneous Infusion Set, Asante Comfort Subcutaneous Infusion Set, Abbott Comfort Subcutaneous Infusion Set	FPA	Substantially Equivalent	Unomedical A/S	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
March 3, 2017	K162746	Ontex and other proprietary names	HEB	Substantially Equivalent	Ontex Bvba	accessdata.fda.gov
December 20, 2016	K160928	Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Natural), Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Green)	KGO	Substantially Equivalent	Hartalega Sdb. Bhd.	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 3, 2016	K160437	PleurX Peritoneal Catheter System	PNG	Unknown	Care Fusion	accessdata.fda.gov
August 10, 2016	K160648	MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio®	FPA	Substantially Equivalent	Unomedical A/S	accessdata.fda.gov
July 28, 2016	K161008	POLYISOPRENE POWDER FREE SURGICAL UNDERGLOVE, POLYISOPRENE POWDER FREE SURGICAL GLOVE	KGO	Substantially Equivalent	Hartalega Sdn Bhd	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
July 27, 2015	K151698	BD Angiocath IV Catheter, BD Insyte IV Catheter	FOZ	Substantially Equivalent	Becton Dickinson Infusion Therapy Systems, Inc.	accessdata.fda.gov
February 24, 2015	K142296	Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Disposable Inner Cannula	JOH	Substantially Equivalent	Covidien	accessdata.fda.gov
January 22, 2015	K143247	Powder Free Nitrile Examination Gloves, Nonsterile,(Blue,Black, and White Colored)	LZA	Substantially Equivalent	Central Medicare Sdn Bhd	accessdata.fda.gov
January 9, 2015	K142635	Medline Silicone Foley Catheter	EZL	Substantially Equivalent	Medline Industries, Inc.	accessdata.fda.gov
December 19, 2014	K142356	Connex Spot Monitor,901058 Vital Signs Monitor Core	MWI	Substantially Equivalent	Welch Allyn, Inc.	accessdata.fda.gov
October 31, 2014	K141660	NAWALUTION SKIN AND WOUND CLEANSER	FRO	Substantially Equivalent	Nawa Heilmittel GmbH	accessdata.fda.gov
September 26, 2014	K140369	MEDLINE NEURO SPONGE	HBA	Substantially Equivalent	Medline Industries, Inc.	accessdata.fda.gov
July 11, 2014	K141582	CP150 ELECTROCARDIOGRAPH WITH SPIROMETRY OPTION	DPS	Substantially Equivalent	Welch Allyn	accessdata.fda.gov
July 10, 2014	K133443	MARATHON NO STING LIQUID SKIN PROTECTANT	KMF	Substantially Equivalent	Advanced Medical Solutions (Plymouth), Ltd.	accessdata.fda.gov
March 11, 2014	K132322	NEWTRON P5 XS B.LED	ELC	Substantially Equivalent	Satelec - Acteon Group	accessdata.fda.gov
February 3, 2014	K132767	MEDLINE SHARPS CONTAINER	MMK	Substantially Equivalent	Medline Industries, Inc.	accessdata.fda.gov
November 7, 2013	K132006	STERILE NITRILE POWDER FREE EXAMINATION GLOVE(VBLU), STERLE NITRILE POWDER FREE EXAMINATION GLOVE(ABLU)	LZA	Substantially Equivalent	Hartalega Sdn Bhd	accessdata.fda.gov
July 5, 2013	K130473	NITRILE POWDER FREE EXAMINATION GLOVE (ABLU)	LZA	Substantially Equivalent	Hartalega Sdn Bhd	accessdata.fda.gov
March 12, 2013	K122634	IODOFOAM IODOPHOR FOAM DRESSING	FRO	Substantially Equivalent	Progressive Wound Care Technologies, LLC	accessdata.fda.gov
May 23, 2012	K120976	MANUKA IG	FRO	Substantially Equivalent	Links Medical Products, Inc.	accessdata.fda.gov
March 23, 2012	K120743	SPECULUM, VAGINAL, NONMETAL	HIB	Substantially Equivalent	Welch Allyn, Inc.	accessdata.fda.gov
August 18, 2011	K111807	MEDLINE POWDER-FREE LATEX SURGICAL GLOVES, STERILE, W/ OR W/O ALOE VERA, WITH PROTEIN CONTENT LABELING CLAIM...	KGO	Substantially Equivalent	Medline Industries, Inc.	accessdata.fda.gov
May 13, 2011	K110771	BD SINGLE USE, HYPODERMIC SYRINGE	FMF	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
September 8, 2010	K101249	STERIGAGE MODEL 1243RA, 1243RB, 1243RE	JOJ	Substantially Equivalent	3M Company	accessdata.fda.gov
July 21, 2010	K101596	KIMBERLY-CLARK PURPLE NITRILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) AND KIMBERLY-CLARK PURPLE NITRILE XTRA POWDER-	LZC	Substantially Equivalent	Kimberly-Clark	accessdata.fda.gov
July 9, 2010	K101680	WELCH ALLYN SPOT VITAL SIGNS LXI MODEL 45000 SERIES	DXN	Substantially Equivalent	Welch Allyn, Inc.	accessdata.fda.gov
June 22, 2010	K101385	DUAL LUER LOCK CAP, MODEL 2C6250	FPA	Substantially Equivalent	Baxter Healthcare Corp	accessdata.fda.gov
December 16, 2009	K091034	AQUACEL AG SURGICAL	FRO	Substantially Equivalent	Convatec	accessdata.fda.gov
December 11, 2009	K091331	PIEZOTOME 2	DZI	Substantially Equivalent	Satelec	accessdata.fda.gov
December 4, 2009	K093199	3M COMPLY BOWIE- DICK TYPE LEAD FREE TEST PACK	JOJ	Substantially Equivalent	3M Company	accessdata.fda.gov
October 9, 2009	K091758	BD SPINAL NEEDLE 27G	BSP	Substantially Equivalent	Becton Dickson & Co.	accessdata.fda.gov
August 26, 2009	K091820	CONTOUR USB BLOOD GLUCOSE METER, GLUCOSE TEST STRIPS; GLUCOFACTS DELUX DIABETES MANAGEMENT SYSTEM	NBW	Substantially Equivalent	Bayer Healthcare	accessdata.fda.gov
March 9, 2009	K082478	WELCH ALLYN CARDIOPERFECT WORKSTATION SOFTWARE (CPWS) V 1.62	BZG	Substantially Equivalent	Welch Allyn, Inc.	accessdata.fda.gov
October 17, 2008	K081594	MEDLINE POWDER-FREE NITRILE EXAMINATION GLOVE WITH ALOE	LZA	Substantially Equivalent	Medline Industries, Inc.	accessdata.fda.gov
June 24, 2008	K081160	AVITA RADAR THERMO IR THERMOMETER, NT1 SERIES	FLL	Substantially Equivalent	Avita Corporation	accessdata.fda.gov
December 18, 2007	K070060	WELCH ALLYN FLEXIPORT DISPOSABLE BLOOD PRESSURE CUFF (ONE-PIECE); REUSABLE BLOOD PRESSURE CUFF (ONE-PIECE)	DXQ	Substantially Equivalent	Welch Allyn, Inc.	accessdata.fda.gov
September 10, 2007	K071565	BIOGEL INDICATOR UNDERGLOVE WITH NON-PYROGENIC STATEMENT	KGO	Substantially Equivalent	Molnlycke Health Care Us, LLC	accessdata.fda.gov
August 3, 2007	K063835	ALLEVYN AG DRESSING	FRO	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
June 26, 2007	K071607	ASA01 HEAVY DUTY SUCTION PUMP	BTA	Substantially Equivalent	Zhongshan A&J Medical Equipment Co., Ltd.	accessdata.fda.gov
May 30, 2007	K071185	MODIFICATION TO: AMBU NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE	GXZ	Substantially Equivalent	Ambu A/S	accessdata.fda.gov
January 29, 2007	K062925	COAGUCHEK XS SYSTEM	GJS	Substantially Equivalent	Roche Diagnostics Corp.	accessdata.fda.gov
December 14, 2006	K062969	MEDLINE STERILE DISPOSABLE SURGICAL GOWNS	FYA	Substantially Equivalent	Medline Industries, Inc.	accessdata.fda.gov
September 11, 2006	K062058	ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; REAGENT STRIP, MODEL 7080	NBW	Substantially Equivalent	Bayer Healthcare	accessdata.fda.gov
July 14, 2006	K061037	PDS PLUS ANTIBACTERIAL SUTURE	NEW	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
April 10, 2006	K053441	BIOGEL LATEX POWDER FREE STERILE SURGEON'S GLOVE	KGO	Substantially Equivalent	Regent Medical Americas, LLC	accessdata.fda.gov
March 10, 2006	K053102	BIOGEL SKINSENSE POWDER-FREE NON-LATEX SURGEON'S GLOVE	KGO	Substantially Equivalent	Regent Medical Americas, LLC	accessdata.fda.gov
November 8, 2005	K051082	MEDTRADE PRODUCTS SKIN PROTECTIVE BARRIER WIPE (STERILE AND PRESERVED)	KMF	Substantially Equivalent	Medtrade Products , Ltd.	accessdata.fda.gov
October 20, 2005	K052720	MEDLINE IODOFORM PACKING STRIPS	FRO	Substantially Equivalent	Medline Industries, Inc.	accessdata.fda.gov
March 30, 2005	K050106	NOVOFINE AUTOCOVER 30G X 8MM	FMI	Substantially Equivalent	Novo Nordisk, Inc.	accessdata.fda.gov
February 11, 2005	K050180	EXPA-SYL	MVL	Substantially Equivalent	Produits Dentaires Pierre Rolland	accessdata.fda.gov
March 5, 2004	K032278	AMBU NEUROLINE SINGLE PATIENT EEG/EP CUP ELECTRODE	GXY	Substantially Equivalent	Ambu, Inc.	accessdata.fda.gov
February 27, 2004	K032843	NEXIVA CLOSED IV CATHETER SYSTEM	FOZ	Substantially Equivalent	Becton Dickinson Infusion Therapy Systems, Inc.	accessdata.fda.gov
August 22, 2003	K032005	MEDTRONIC MINIMED PARADIGM RESERVOIR, MODEL MMT-332	FRN	Substantially Equivalent	Medtronic Minimed	accessdata.fda.gov
May 6, 2003	K030580	SURETEMP PLUS	FLL	Substantially Equivalent	Welch Allyn, Inc.	accessdata.fda.gov
November 21, 2002	K023711	DIGITAL THERMOMETER CLASSIC TYPE AND FLEXIBLE TYPE	FLL	Substantially Equivalent	Acute Ideas Co. , Ltd.	accessdata.fda.gov
June 21, 2002	K013814	ABSORBENT ANTIMICROBIAL WOUND DRESSING	FRO	Substantially Equivalent	Convatec, A Division of E.R. Squibb & Sons	accessdata.fda.gov
June 14, 2002	K020907	NEUROLINE, SUBDERMAL NEEDLE ELECTRODES	IKT	Substantially Equivalent	Medicotest A/S	accessdata.fda.gov
May 3, 2002	K020393	MASTER & FRANK SURGICAL DRAPES (STERILE)	KKX	Substantially Equivalent	Master & Frank Enterprses Co., Ltd.	accessdata.fda.gov
April 16, 2002	K013621	BD SAF-T PRN LUER ACTIVATED VALVE, MODEL 385100	FPA	Substantially Equivalent	Becton Dickinson Infusion Therapy Systems, Inc.	accessdata.fda.gov
November 8, 2001	K011994	ACRYDERM SILVER ANTTIMICROBIAL WOUND GEL MODEL# A-002101	MGQ	Substantially Equivalent	Acrymed, Inc.	accessdata.fda.gov
August 17, 2001	K012455	WELCH ALLYN DURASHOCK BLOOD PRESSURE SYSTEM	DXQ	Substantially Equivalent	Welch Allyn, Inc.	accessdata.fda.gov
June 7, 2001	K011071	PARADIGM QUICK-SET INFUSION SET	FPA	Substantially Equivalent	Maersk Medical A/S	accessdata.fda.gov
March 1, 2001	K010188	BD ECLIPSE HYPODERMIC NEEDLE	FMI	Substantially Equivalent	Bd Medical Systems	accessdata.fda.gov
January 25, 2001	K003376	WELCH ALLYN 11800 OPTHALMOSCOPE	HLI	Substantially Equivalent	Welch Allyn, Inc.	accessdata.fda.gov
January 23, 2001	K002968	MEDLINE STERILIZATION WRAP	FRG	Substantially Equivalent	Medline Industries, Inc.	accessdata.fda.gov
October 19, 2000	K003225	SOLUTION ADMINISTRATION SETS WITH CAPLESS LUER ACTIVATED VALVE	FPA	Substantially Equivalent	Baxter Healthcare Corp	accessdata.fda.gov
August 23, 1999	K991559	MEDLINE PROHIBIT SERIES SURGICAL MASK WITH FLUID SHIELD	FXX	Substantially Equivalent	Medline Industries, Inc.	accessdata.fda.gov
March 23, 1999	K983794	CHEMO MINI SPIKE PLUS	LHI	Substantially Equivalent	B. Braun of America, Inc.	accessdata.fda.gov
August 17, 1998	K981792	SOLUTION ADMINISTRATION SET	FPA	Substantially Equivalent	Baxter Healthcare Corp	accessdata.fda.gov
June 11, 1997	K971444	3M RED DOT 2234 & 2266 RADIOLUCENT MONITORING ELECTRODES	DRX	Substantially Equivalent	3M Medical Products Group	accessdata.fda.gov
March 31, 1997	K964853	INTRAVIA CONTAINER, EMPTY	KPE	Substantially Equivalent	Baxter Healthcare Corp	accessdata.fda.gov
February 25, 1997	K964142	MEDLINE DISPOSABLE SURGICAL DRAPES AND GOWNS	KKX	Substantially Equivalent	Medline Industries, Inc.	accessdata.fda.gov
November 26, 1996	K962205	STERILE AND NON-STERILE O.R. TOWELS, STERILE AND NON-STERILE X-RAY DETECTABLE O.R. TOWELS, SINGLE USE	KKX	Substantially Equivalent	Medline Industries, Inc.	accessdata.fda.gov
October 28, 1996	K962714	PASSY-MUIR LOW-PROFILE TRACHEOSTOMY AND VENTILATOR SPEAKING VALVE; PRODUCT NUMBER PMV 2000 OR PMTSV 2000	JOH	Substantially Equivalent	Passy-Muir, Inc.	accessdata.fda.gov
October 4, 1996	K962173	SHIKEY TRACHEOSTOMY TUBES AND ACCESSORIES	JOH	Substantially Equivalent	Mallinckrodt Medical	accessdata.fda.gov
September 16, 1996	K962826	MEDLINE RADIOLOGY-DIAGNOSTIC KITS	LRO	Substantially Equivalent	Medline Industries, Inc.	accessdata.fda.gov

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Updated November 1, 2024. 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.