Data / Medical devices / Canada / Innopex Limited

Innopex Limited: FDA-registered device maker in Toronto Ontario, Canada, 103 510(k) clearances

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

Innopex Limited is registered with the FDA (registration 3001124136) in Toronto Ontario, Canada. It lists 100 device types. The FDA files 103 510(k) clearances under its listings, the newest dated April 10, 2026. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this one Watch Innopex Limited

FDA registration number: 3001124136
Address: 240 Bartor Rd Units 9&10, Toronto Ontario, Canada, M9M2W6
Owner or operator: Innopex Limited (10047406)
Roles: Exporter to the US
First device listed: August 25, 2014
Registered through: 2027
Brand names listed: Absorbabale Sutures Multiple, Blood Collection set, Blood collection tubes, DISPOSABLE SYRINGE, Guiding Catheter, IV Administration Set Multiple, Needle Injection Dispossable, OPHTHALMOSCOPE MULTIPLE and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Catheter	KGZ	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
Apparatus, Suction, Patient Care	DWM	2	Exporter to the US	accessdata.fda.gov
Applicator, Absorbent Tipped, Sterile	KXG	1	Exporter to the US	accessdata.fda.gov
Bag, Urine Collection, Leg, For External Use, Sterile	FAQ	1	Exporter to the US	accessdata.fda.gov
Bandage, Cast	ITG	1	Exporter to the US	accessdata.fda.gov
Bandage, Elastic	FQM	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
Blade, Saw, General & Plastic Surgery, Surgical	GFA	1	Exporter to the US	accessdata.fda.gov
Blade, Scalpel	GES	1	Exporter to the US	accessdata.fda.gov
Bottle, Collection, Vacuum	KDQ	2	Exporter to the US	accessdata.fda.gov
Brush, Scrub, Operating-Room	GEC	1	Exporter to the US	accessdata.fda.gov
Bur, Surgical, General & Plastic Surgery	GFF	1	Exporter to the US	accessdata.fda.gov
Cannula, Surgical, General & Plastic Surgery	GEA	1	Exporter to the US	accessdata.fda.gov
Cap, Surgical	FYF	1	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, Percutaneous	DQY	2	Exporter to the US	accessdata.fda.gov
Catheter, Retention Type, Balloon	EZL	2	Exporter to the US	accessdata.fda.gov
Catheter, Ureteral, Gastro-Urology	EYB	2	Exporter to the US	accessdata.fda.gov
Catheter, Urological	KOD	2	Exporter to the US	accessdata.fda.gov
Cement, Stomal Appliance, Ostomy	EZR	1	Exporter to the US	accessdata.fda.gov
Clamp, Umbilical	HFW	2	Exporter to the US	accessdata.fda.gov
Collector, Ostomy	EXB	1	Exporter to the US	accessdata.fda.gov
Collector, Urine, (And Accessories) For Indwelling Catheter	KNX	2	Exporter to the US	accessdata.fda.gov
Container, I.V.	KPE	2	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
Cover, Barrier, Protective	MMP	2	Exporter to the US	accessdata.fda.gov
Culture Media, Non-Propagating Transport	JSM	1	Exporter to the US	accessdata.fda.gov
Device, Medical Examination, Ac Powered	KZF	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
Drape, Surgical, Antimicrobial	KKX	2	Exporter to the US	accessdata.fda.gov
Dressing, Compression	MHW	1	Exporter to the US	accessdata.fda.gov
Dressing, Wound, Drug	FRO	U	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
Electrode, Electrocardiograph	DRX	2	Exporter to the US	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Exporter to the US	accessdata.fda.gov
Enteral Specific Transition Connectors	PIO	2	Exporter to the US	accessdata.fda.gov
Esthesiometer	GXB	1	Exporter to the US	accessdata.fda.gov
Filter, Bacterial, Breathing-Circuit	CAH	2	Exporter to the US	accessdata.fda.gov
Flask, Tissue Culture	KJA	1	Exporter to the US	accessdata.fda.gov
Floss, Dental	JES	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
Gown, Surgical	FYA	2	Exporter to the US	accessdata.fda.gov
Indicator, Physical/Chemical Sterilization Process	JOJ	2	Exporter to the US	accessdata.fda.gov
Instrument, Diamond, Dental	DZP	1	Exporter to the US	accessdata.fda.gov
Instrument, Surgical, Disposable	KDC	1	Exporter to the US	accessdata.fda.gov
Introducer, Catheter	DYB	2	Exporter to the US	accessdata.fda.gov
Light, Surgical, Accessories	FTA	2	Exporter to the US	accessdata.fda.gov
Mask, Surgical	FXX	2	Exporter to the US	accessdata.fda.gov
Material, Tooth Shade, Resin	EBF	2	Exporter to the US	accessdata.fda.gov
Mattress, Flotation Therapy, Non-Powered	IKY	1	Exporter to the US	accessdata.fda.gov
Medical Glove, Specialty	LZC	1	Exporter to the US	accessdata.fda.gov
Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs	OPJ	1	Exporter to the US	accessdata.fda.gov
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
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
Pack, Hot Or Cold, Disposable	IMD	1	Exporter to the US	accessdata.fda.gov
Pack, Hot Or Cold, Reusable	IME	1	Exporter to the US	accessdata.fda.gov
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
Pump, Infusion, Enteral	LZH	2	Exporter to the US	accessdata.fda.gov
Razor, Surgical	LWK	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
Speculum, Vaginal, Nonmetal	HIB	2	Exporter to the US	accessdata.fda.gov
Sterilizer, Chemical	MLR	2	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
Surgeon'S Gloves	KGO	1	Exporter to the US	accessdata.fda.gov
Suture, Absorbable, Synthetic	GAN	2	Exporter to the US	accessdata.fda.gov
Suture, Absorbable, Synthetic, Polyglycolic Acid	GAM	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, Transport, Aerobic	JTW	1	Exporter to the US	accessdata.fda.gov
System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile	EYZ	1	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
Toothbrush, Manual	EFW	1	Exporter to the US	accessdata.fda.gov
Toothbrush, Powered	JEQ	1	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, Vacuum Sample, With Anticoagulant	GIM	2	Exporter to the US	accessdata.fda.gov
Tubes, Vials, Systems, Serum Separators, Blood Collection	JKA	2	Exporter to the US	accessdata.fda.gov
Wire, Guide, Catheter	DQX	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 103.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
April 10, 2026	K252506	BD Vacutainer® Safety-Lok Blood Collection Set; BD Vacutainer® Safety-Lok Blood Collection Set with Pre-Attached Holder	JKA	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
March 13, 2026	K252040	BD Vacutainer® Plasma Separator Tubes (PST), BD Vacutainer® Sodium Heparin Blood Collection Tubes	JKA	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
August 22, 2025	K243660	Monoject 1mL Tuberculin Syringe Luer-Lock Tip (1180100777); Monoject 3mL Syringe, Luer-Lock Tip (1180300777); Monoject 6mL Syringe, Luer-Lock Tip (1180600777); Monoject 12mL Syringe, Luer-Lock Tip (1181200777); Monoject 20mL Syringe, Luer-Lock Tip (1182000777); Monoject 35mL Syringe, Luer-Lock Tip (1183500777); Monoject 60mL Syringe, Luer-Lock Tip (1186000777); Monoject 3mL Syringe, Luer-Lock Tip (8881513934); Monoject 6mL Syringe , Luer-Lock Tip (8881516937); Monojec	FMF	Substantially Equivalent	Cardinalhealth	accessdata.fda.gov
July 3, 2025	K243207	BD Vacutainer® Eclipse Blood Collection Needle	JKA	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
March 21, 2025	K243649	BD Vacutainer® Multiple Sample Luer Adapter	JKA	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
November 1, 2024	K242320	BD Vacutainer® One Use Holder	JKA	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
February 2, 2024	K231373	BD Vacutainer® K2 EDTA Blood Collection Tubes	JKA	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
December 20, 2023	K230855	BD Vacutainer® Serum Separator (SST) Blood Collection Tubes	JKA	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
July 7, 2023	K230080	Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Blood	JKA	Substantially Equivalent	Yangzhou Medline Industry, Co., Ltd.	accessdata.fda.gov
June 21, 2023	K223376	Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan Insulin Safety Syringe 0.5mL, 31G x 6mm (8881893150); Monoject Magellan Insulin Safety Syringe 0.3mL, 31G x 6mm (8881893130)	MEG	Substantially Equivalent	Cardinal Health200, LLC	accessdata.fda.gov
March 24, 2023	K223236	Medline Surgical Face Mask and Medline Procedural Face Mask	FXX	Substantially Equivalent	Medline Industries, LP	accessdata.fda.gov
March 24, 2023	K220212	BD Vacutainer® Push Button Blood Collection Set, BD Vacutainer® Push Button Blood Collection Set with Pre-Attached Holder	JKA	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
March 10, 2023	K222478	BD Vacutainer® Luer-Lok Access Device, BD Vacutainer® Blood Transfer Device	JKA	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
December 20, 2022	K221603	Kangaroo OMNI Enteral Feeding Pump (385400 );Kangaroo OMNI Feeding Set 500ml (B5FD );Kangaroo OMNI ENtelliSet 500ml (E5FD );Kangaroo OMNI Feeding Set 1000ml (B10FD );Kangaroo OMNI ENtelliSet 1000ml (E10FD );Kangaroo OMNI ENPlus Spike Set (BSPFD );Kangaroo OMNI ENtelliSet ENPlus Spike ( ESPFD );Kangaroo OMNI Feeding Set 500ml with Flush Bag ( B5FF);Kangaroo OMNI ENtelliSet 500ml with Flush Bag (E5FF);Kangaroo OMNI Feeding Set 1000ml with Flush Bag ( E10FF );Kangaroo OMNI	LZH	Substantially Equivalent	Cardinal Health, LLC	accessdata.fda.gov
July 1, 2022	K211085	BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural Needle	BSP	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
February 17, 2022	K220137	Lunderquist Extra Stiff Wire Guide	DQX	Substantially Equivalent	William Cook Europe Aps	accessdata.fda.gov
December 22, 2021	K210978	BD Quincke Spinal Needle, BD Whitacre Spinal Needle, BD Spinal Introducer Needle	BSP	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
July 13, 2020	K200960	Medline Powder Free Examination Gloves (Tested for use with Chemotherapy Drugs)	LZA	Substantially Equivalent	Medline Industires, Inc.	accessdata.fda.gov
March 20, 2020	K193327	Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus Full Coverage Gown, Open Back, Cardinal Health ChemoPlus Full Coverage Sleeve	FYA	Substantially Equivalent	Cardinal Health200, LLC	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
December 12, 2019	K191163	Lumax Guiding Catheter	DQY	Substantially Equivalent	Cook Incorporated	accessdata.fda.gov
March 14, 2019	K182589	BD Plastipak Syringe	FMF	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
September 14, 2018	K180182	Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Catheter	EYB	Substantially Equivalent	Cook Incorporated	accessdata.fda.gov
March 30, 2018	K171988	Performer Guiding Sheath	DYB	Substantially Equivalent	Cook Incorporated	accessdata.fda.gov
December 15, 2017	K173354	BD Nexiva Diffusics Closed IV Catheter Systems	FOZ	Substantially Equivalent	Becton Dickinson Infusion Therapy Systems, Inc.	accessdata.fda.gov
December 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
October 31, 2016	K160450	Pleurx Pleural Catheter System	DWM	Substantially Equivalent	Care Fusion	accessdata.fda.gov
May 27, 2016	K161170	BD Eclipse Hypodermic Needle	FMI	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
April 13, 2016	K160693	Neptune E-SEP Smoke Evacuation Pencil	GEI	Substantially Equivalent	Stryker Corporation	accessdata.fda.gov
January 13, 2016	K151725	STERRAD NX Sterilizer, STERRAD 100NX Sterilizer	MLR	Substantially Equivalent	Advanced Sterilization Products	accessdata.fda.gov
July 24, 2015	K151628	Medline ENFit Connectors	PIO	Substantially Equivalent	Medline Industries, Inc.	accessdata.fda.gov
April 27, 2015	K150286	Medline Enteral Feeding Sets	PIF	Substantially Equivalent	Medline Industries, Inc.	accessdata.fda.gov
January 9, 2015	K142635	Medline Silicone Foley Catheter	EZL	Substantially Equivalent	Medline Industries, Inc.	accessdata.fda.gov
January 2, 2014	K130670	HYDROFERA BLUE PU BACTERIOSTATIC DRESSING	FRO	Substantially Equivalent	Hydrofera, LLC	accessdata.fda.gov
July 5, 2013	K130404	TIBURON SURGICAL DRAPE	KKX	Substantially Equivalent	Cardinal Health200, LLC	accessdata.fda.gov
April 5, 2013	K123892	MEPILEX TRANSFER AG	FRO	Substantially Equivalent	Molnlycke Health Care	accessdata.fda.gov
November 8, 2012	K121607	TERUMO(R) NEEDLE	FMI	Substantially Equivalent	Terumo (Philippines) Corporation	accessdata.fda.gov
October 3, 2012	K111518	STERRAD CHEMIAL INDICATOR STRIP MODEL 14100	JOJ	Substantially Equivalent	Advanced Sterilization Products	accessdata.fda.gov
April 12, 2012	K113583	CURAD ANTIBACTERIAL BANDAGE	FRO	Substantially Equivalent	Medline Industries, Inc.	accessdata.fda.gov
September 8, 2011	K111577	MEDLINE VIAL DECANTER	LHI	Substantially Equivalent	Medline Industries, 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 13, 2011	K110771	BD SINGLE USE, HYPODERMIC SYRINGE	FMF	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
September 15, 2010	K100029	MEPILEX BORDER AG DRESSING	FRO	Substantially Equivalent	Molnlycke Health Care	accessdata.fda.gov
August 23, 2010	K101603	BEAUTIFIL FLOW PLUS	EBF	Substantially Equivalent	Shofu Dental Corp.	accessdata.fda.gov
January 21, 2010	K093972	BD MICROTAINER MAP MICROTUBE FOR AUTOMATED PROCESS, MODEL 363706	JKA	Substantially Equivalent	Becton, Dickinson & CO	accessdata.fda.gov
January 21, 2010	K092250	MEDLINE RED RUBBER URETHRAL CATHETER	EYB	Substantially Equivalent	Medline Industries, Inc.	accessdata.fda.gov
January 7, 2010	K093349	MEDLINE CURAD WOUND DRESSINGS	FRO	Substantially Equivalent	Medline Industries, Inc.	accessdata.fda.gov
September 24, 2009	K091964	CREST GLIDE CLINICAL GUM PROTECTION DENTAL FLOSS	JES	Substantially Equivalent	Procter & Gamble Co.	accessdata.fda.gov
January 30, 2009	K090096	ALL-IN-ONE CONTAINER	KPE	Substantially Equivalent	Baxter Healthcare Corporation	accessdata.fda.gov
July 18, 2007	K071423	MEDLINE LATEX FOLEY CATHETER	EZL	Substantially Equivalent	Medline Industries, Inc.	accessdata.fda.gov
July 13, 2007	K071354	MEPILEX AG DRESSING	FRO	Substantially Equivalent	Monlycke Health Care	accessdata.fda.gov
June 5, 2006	K061351	ORAL-B SONIC COMPLETE	JEQ	Substantially Equivalent	Braun GmbH	accessdata.fda.gov
May 22, 2006	K060649	GENIUS 2 INFRARED TYMPANIC ELECTRONIC THERMOMETER, MODEL 303000	FLL	Substantially Equivalent	Tyco Healthcare Group LP	accessdata.fda.gov
October 20, 2005	K052720	MEDLINE IODOFORM PACKING STRIPS	FRO	Substantially Equivalent	Medline Industries, Inc.	accessdata.fda.gov
August 3, 2005	K051378	POWDER-FREE BLUE NITRILE EXAMINATION GLOVES (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)	LZA	Substantially Equivalent	Medline	accessdata.fda.gov
February 25, 2004	K033232	COLORADO MICRODISSECTION NEEDLE	GEI	Substantially Equivalent	Stryker Corp.	accessdata.fda.gov
November 13, 2003	K032444	NITRILE POWDER-FREE EXAMINATION GLOVES WITH LOTION COATING AND USE FOR CHEMOTHERAPY	LZC	Substantially Equivalent	Cardinalhealth	accessdata.fda.gov
September 22, 2003	K032065	MEDLINE BAND BAGS AND EQUIPMENT COVERS	MMP	Substantially Equivalent	Medline Industries, Inc.	accessdata.fda.gov
June 11, 2003	K024010	DOVER SILVER HYDROGEL COATED SILICONE FOLEY CATHETER	EZL	Substantially Equivalent	The Kendall Company Div. of Tyco Healthcare Group	accessdata.fda.gov
May 6, 2003	K030580	SURETEMP PLUS	FLL	Substantially Equivalent	Welch Allyn, Inc.	accessdata.fda.gov
March 26, 2003	K024240	BD VACUTAINER PLUS PLASTIC URINE C&S PRESERVAYIVE TUBES AND KITS	JSM	Substantially Equivalent	Bd	accessdata.fda.gov
July 19, 2002	K021475	BD SINGLE LUMEN NEEDLE, SYRINGE AND BLOOD COLLECTION SET	FMI	Substantially Equivalent	Bd	accessdata.fda.gov
February 14, 2002	K020304	DISPOSABLE LIGHT HANDLE AND ADAPTOR	FTA	Substantially Equivalent	Aspen Surgical Products, Inc.	accessdata.fda.gov
January 11, 2002	K013462	HYDROFERA BACTERIOSTATIC WOUND DRESSING	FRO	Substantially Equivalent	Hydrofera, LLC	accessdata.fda.gov
December 21, 2001	K013800	INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUTOGUARD, AUTOGUARD PRO, INTIMA, AND SAF-T-INTIMA INTRAVASCULAR CATHETE	FOZ	Substantially Equivalent	Becton Dickinson Infusion Therapy Systems, Inc.	accessdata.fda.gov
October 25, 2001	K012736	MONOJECT SAFETY NEEDLE	FMI	Substantially Equivalent	Tyco Healthcare	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
July 28, 1999	K991702	MICROTAINER BRAND CHEMISTRY TUBES WITH MICROGARD CLOSURE, MODEL 365965, 365985, 365963, 365967, 36578	JKA	Substantially Equivalent	Becton Dickinson Vacutainer Systems	accessdata.fda.gov
April 30, 1999	K983610	CLEAR-GUARD MIDI, CLEAR-GUARD MIDI W/FLEXTUBE, CLEAR-THERM MINI, CLEAR-THERM MINI W/FLEXTUBE, MODELS 1644,1644-T,1831,18	CAH	Substantially Equivalent	Intersurgical, Inc.	accessdata.fda.gov
December 4, 1997	K973703	JACKSON-PRATT HEMADUCT WOUND DRAIN, JACKSON-PRATT GOLD HEMADUCT WOUND DRAIN	GBX	Substantially Equivalent	Allegiance Healthcare Corp.	accessdata.fda.gov
July 22, 1997	K972404	VACUTAINER BRAND SAFETY BLOOD COLLECTION ASSEMBLY(MULTIPLE)	KJA	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic	accessdata.fda.gov
April 9, 1997	K970796	3M RED DOT 2560 & 2570 MONITORING ELECTRODES	DRX	Substantially Equivalent	3M Healthcare	accessdata.fda.gov
June 21, 1996	K961225	CONTINUFLO SOLUTION SET/SECONDARY MEDICATION SET	FPA	Substantially Equivalent	Baxter Healthcare Corp	accessdata.fda.gov
March 29, 1996	K960250	VACUTAINER BRAND PLUS SERUM & SST TUBES	JKA	Substantially Equivalent	Becton Dickinson Vacutainer Systems	accessdata.fda.gov
March 28, 1996	K960653	MONOCRYL (POLIGLECAPRONE 25) SUTURE, DYED (MODIFIED)	GAN	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
January 30, 1996	K954483	STRYKER SAGITTAL SAW ATTACHMENT	GFA	Substantially Equivalent	Stryker Instruments	accessdata.fda.gov
November 28, 1995	K954592	VACUTAINER BRAND PST PLASMA SEPARATION TUBE	JKA	Substantially Equivalent	Becton Dickinson Vacutainer Systems	accessdata.fda.gov
October 7, 1995	K951254	SAFETYGLIDE NEEDLE	FMI	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic	accessdata.fda.gov
November 10, 1994	K944566	VACUTAINER BRAND PLUS SODIUM HEPARIN TUBE	JKA	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic	accessdata.fda.gov
August 30, 1994	K940697	BECTON DICKINSON INTERLINK(TM) LEVER/Y LOCK	FPA	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic	accessdata.fda.gov
August 29, 1994	K941991	IN-ROOM AND SHARPSTAR	MMK	Substantially Equivalent	Sage Products, Inc.	accessdata.fda.gov
August 2, 1994	K941272	KLEENSPEC	HIB	Substantially Equivalent	Welch Allyn, Inc.	accessdata.fda.gov
November 15, 1993	K933400	KENDALL CURITY 100% SILICONE FOLEY CATHETER W/TEMPERATURE SENSOR	KOD	Substantially Equivalent	Kendall Healthcare Products Co. Div.Of Tyco Health	accessdata.fda.gov
June 24, 1993	K930697	MEDLINE STERILE GAUZE SPONGES	NAD	Substantially Equivalent	Medline Industries, Inc.	accessdata.fda.gov
November 3, 1992	K921493	LS100 HALOGEN EXAMINATION LIGHT, MODEL NO: 44100	KZF	Substantially Equivalent	Welch Allyn, Inc.	accessdata.fda.gov
May 13, 1991	K911913	PRECISION GLIDE - ENHANCED SURGICAL BLADE	GES	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic	accessdata.fda.gov
March 28, 1991	K910524	SURGICAL CLIPPER	LWK	Substantially Equivalent	Baxter Healthcare Corp	accessdata.fda.gov
March 20, 1991	K905614	JACKSON-PRATT, HIGH LUBRICITY AND WOUND DRAINS	GBX	Substantially Equivalent	Baxter Healthcare Corp	accessdata.fda.gov
August 9, 1990	K901449	VACUTAINER PLUS WITH HEMOGARD CLOSURE	JKA	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic	accessdata.fda.gov
August 26, 1988	K883024	ORAL-B FLOSSERS	JES	Substantially Equivalent	Oral-B Laboratories	accessdata.fda.gov
April 2, 1984	K840269	MC 2000 OSTOMY POUCHES	EXB	Substantially Equivalent	Coloplast A/S	accessdata.fda.gov
September 29, 1983	K832855	TPE DIAMOND POINTS	DZP	Substantially Equivalent	Shofu Dental Corp.	accessdata.fda.gov
April 12, 1983	K830945	SUR-FIT FLEXIBLE	EXB	Substantially Equivalent	Convatec, A Division of E.R. Squibb & Sons	accessdata.fda.gov
January 28, 1982	K820086	CURITY SURGICAL SCRUB BRUSH SPONGE	GEC	Substantially Equivalent	The Kendal Co.	accessdata.fda.gov
June 26, 1981	K811447	SHILEY DISPOSABLE CANNULA TRACH. TUBE	BTO	Substantially Equivalent	Shiley, Inc.	accessdata.fda.gov
June 2, 1981	K811291	TEGADERM TRANSPARENT DRESSING	KGX	Substantially Equivalent	3M Company	accessdata.fda.gov
March 2, 1981	K810156	ARGYLE SALEM SUMP TUBE	KNT	Substantially Equivalent	Sherwood Medical Co.	accessdata.fda.gov
January 8, 1981	K803100	STOMAHESIVE PASTE PROTECTIVE SKIN BARR	EZR	Substantially Equivalent	E. R. Squibb & Sons, Inc.	accessdata.fda.gov
April 4, 1979	K790366	URINE CULTURE KIT	JTW	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic	accessdata.fda.gov

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Updated April 10, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.