Data / Medical devices / Netherlands / Schneider ASR B.V.

Schneider ASR B.V.: FDA-registered device maker in Rotterdam-Albrandswaard Zuid-Holland, Netherlands, 157 510(k) clearances and 2 PMA approvals

Name: Schneider ASR B.V. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Schneider ASR B.V. is registered with the FDA (registration 3016678045) in Rotterdam-Albrandswaard Zuid-Holland, Netherlands. It lists 137 device types. The FDA files 157 510(k) clearances and 2 PMA approvals under its listings, the newest dated June 14, 2024. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3016678045
Address: Willem Barentszstraat 31, Rotterdam-Albrandswaard Zuid-Holland, Netherlands, NL-3165 AA
Owner or operator: Medical Wholsale Suplies, Inc (10046376)
Roles: Exporter to the US
First device listed: March 14, 2014
Registered through: 2027
Brand names listed: APPARATUS, EXHAUST, SURGICAL, BAIR HUGGER BLOOD/FLUID WARMER, COOK PEDIATRIC FLEXOR URETERAL ACCESS SHEALTH, CROSSFLOW, Connecting Tubes and Pressure Monit; Filler Tubes, Various, ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED, EXEMPT, Halyard, ISOLATION GOWN and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Arthroscopic	NBH	1	Exporter to the US	accessdata.fda.gov
Accessories, Cleaning Brushes, For Endoscope	MNL	1	Exporter to the US	accessdata.fda.gov
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	CCK	2	Exporter to the US	accessdata.fda.gov
Anesthesia Conduction Kit	CAZ	2	Exporter to the US	accessdata.fda.gov
Anoscope And Accessories	FER	2	Exporter to the US	accessdata.fda.gov
Apparatus, Exhaust, Surgical	FYD	2	Exporter to the US	accessdata.fda.gov
Apparatus, Suction, Ward Use, Portable, Ac-Powered	JCX	2	Exporter to the US	accessdata.fda.gov
Appliance, Fixation, Spinal Intervertebral Body	KWQ	2	Exporter to the US	accessdata.fda.gov
Applier, Surgical, Clip	GDO	1	Exporter to the US	accessdata.fda.gov
Arthroscope	HRX	2	Exporter to the US	accessdata.fda.gov
Balloon, Epistaxis	EMX	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
Biopsy Needle	FCG	2	Exporter to the US	accessdata.fda.gov
Blade, Saw, General & Plastic Surgery, Surgical	GFA	1	Exporter to the US	accessdata.fda.gov
Blood Pressure Cuff	DXQ	2	Exporter to the US	accessdata.fda.gov
Bone Cement	LOD	2	Exporter to the US	accessdata.fda.gov
Bronchoscope (Flexible Or Rigid)	EOQ	2	Exporter to the US	accessdata.fda.gov
Bur, Ear, Nose And Throat	EQJ	1	Exporter to the US	accessdata.fda.gov
Bur, Surgical, General & Plastic Surgery	GFF	1	Exporter to the US	accessdata.fda.gov
Cable, Electrode	IKD	2	Exporter to the US	accessdata.fda.gov
Cable, Transducer And Electrode, Patient, (Including Connector)	DSA	2	Exporter to the US	accessdata.fda.gov
Cannula, Manipulator/Injector, Uterine	LKF	2	Exporter to the US	accessdata.fda.gov
Cannula, Ophthalmic	HMX	1	Exporter to the US	accessdata.fda.gov
Catheter, Angioplasty, Peripheral, Transluminal	LIT	2	Exporter to the US	accessdata.fda.gov
Catheter, Conduction, Anesthetic	BSO	2	Exporter to the US	accessdata.fda.gov
Catheter, Electrode Recording, Or Probe, Electrode Recording	DRF	2	Exporter to the US	accessdata.fda.gov
Catheter, Intracardiac Mapping, High-Density Array	MTD	2	Exporter to the US	accessdata.fda.gov
Catheter, Intravascular, Diagnostic	DQO	2	Exporter to the US	accessdata.fda.gov
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	FOZ	2	Exporter to the US	accessdata.fda.gov
Catheter, Nephrostomy, General & Plastic Surgery	GBO	1	Exporter to the US	accessdata.fda.gov
Catheter, Percutaneous	DQY	2	Exporter to the US	accessdata.fda.gov
Catheter, Thrombus Retriever	NRY	2	Exporter to the US	accessdata.fda.gov
Catheter, Ultrasound, Intravascular	OBJ	2	Exporter to the US	accessdata.fda.gov
Catheters, Transluminal Coronary Angioplasty, Percutaneous	LOX	2	Exporter to the US	accessdata.fda.gov
Cement Obturator	LZN	2	Exporter to the US	accessdata.fda.gov
Clinical Electronic Thermometer	SDV	2	Exporter to the US	accessdata.fda.gov
Clip, Implantable	FZP	2	Exporter to the US	accessdata.fda.gov
Clip, Scalp	HBO	2	Exporter to the US	accessdata.fda.gov
Collector, Ostomy	EXB	1	Exporter to the US	accessdata.fda.gov
Component, Traction, Non-Invasive	KQZ	1	Exporter to the US	accessdata.fda.gov
Computer, Diagnostic, Programmable	DQK	2	Exporter to the US	accessdata.fda.gov
Coronary Drug-Eluting Stent	NIQ	3	Exporter to the US	accessdata.fda.gov
Curette, Nasal	KAP	1	Exporter to the US	accessdata.fda.gov
Cystoscope And Accessories, Flexible/Rigid	FAJ	2	Exporter to the US	accessdata.fda.gov
Dermatome	GFD	1	Exporter to the US	accessdata.fda.gov
Device, Medical Examination, Ac Powered	KZF	1	Exporter to the US	accessdata.fda.gov
Dialyzer, High Permeability With Or Without Sealed Dialysate System	KDI	2	Exporter to the US	accessdata.fda.gov
Dislodger, Stone, Biliary	LQR	2	Exporter to the US	accessdata.fda.gov
Dispenser, Cement	KIH	1	Exporter to the US	accessdata.fda.gov
Drape, Surgical, Exempt	PUI	2	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
Drills, Burrs, Trephines & Accessories (Simple, Powered)	HBE	2	Exporter to the US	accessdata.fda.gov
Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes	NVN	3	Exporter to the US	accessdata.fda.gov
Electrode, Electrocardiograph	DRX	2	Exporter to the US	accessdata.fda.gov
Electrode, Electrosurgical	JOS	2	Exporter to the US	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Exporter to the US	accessdata.fda.gov
Endoilluminator	MPA	2	Exporter to the US	accessdata.fda.gov
Endoscope, Accessories, Narrow Band Spectrum	NWB	2	Exporter to the US	accessdata.fda.gov
Endoscopic Access Overtube, Gastroenterology-Urology	FED	2	Exporter to the US	accessdata.fda.gov
Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt	PTS	2	Exporter to the US	accessdata.fda.gov
Endoscopic Irrigation/Suction System	OCX	2	Exporter to the US	accessdata.fda.gov
Fastener, Fixation, Biodegradable, Soft Tissue	MAI	2	Exporter to the US	accessdata.fda.gov
Fastener, Fixation, Nondegradable, Soft Tissue	MBI	2	Exporter to the US	accessdata.fda.gov
Generator, Lesion, Radiofrequency	GXD	2	Exporter to the US	accessdata.fda.gov
Gown, Isolation, Surgical	FYC	2	Exporter to the US	accessdata.fda.gov
Gown, Surgical	FYA	2	Exporter to the US	accessdata.fda.gov
Holder, Needle, Gastroenterologic	FHQ	1	Exporter to the US	accessdata.fda.gov
Hood, Surgical	FXY	2	Exporter to the US	accessdata.fda.gov
Hysteroscope (And Accessories)	HIH	2	Exporter to the US	accessdata.fda.gov
Indicator, Biological Sterilization Process	FRC	2	Exporter to the US	accessdata.fda.gov
Indicator, Physical/Chemical Sterilization Process	JOJ	2	Exporter to the US	accessdata.fda.gov
Instrument, Biopsy	KNW	2	Exporter to the US	accessdata.fda.gov
Instrument, Manual, Surgical, General Use	MDM	1	Exporter to the US	accessdata.fda.gov
Insufflator, Endoscopic Vessel Harvesting	OSV	2	Exporter to the US	accessdata.fda.gov
Insufflator, Hysteroscopic	HIG	2	Exporter to the US	accessdata.fda.gov
Insufflator, Laparoscopic	HIF	2	Exporter to the US	accessdata.fda.gov
Introducer, Catheter	DYB	2	Exporter to the US	accessdata.fda.gov
Laparoscope, General & Plastic Surgery	GCJ	2	Exporter to the US	accessdata.fda.gov
Laryngoscope, Rigid	CCW	1	Exporter to the US	accessdata.fda.gov
Laser, Ophthalmic	HQF	2	Exporter to the US	accessdata.fda.gov
Lavage, Jet	FQH	2	Exporter to the US	accessdata.fda.gov
Ligator, Hemorrhoidal	FHN	2	Exporter to the US	accessdata.fda.gov
Marker, Radiographic, Implantable	NEU	2	Exporter to the US	accessdata.fda.gov
Mask, Surgical	FXX	2	Exporter to the US	accessdata.fda.gov
Mesh, Surgical, Deployer	ORQ	2	Exporter to the US	accessdata.fda.gov
Mesh, Surgical, Polymeric	FTL	2	Exporter to the US	accessdata.fda.gov
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling	PAH	2	Exporter to the US	accessdata.fda.gov
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator	OTN	2	Exporter to the US	accessdata.fda.gov
Mixer, Cement, For Clinical Use	JDZ	1	Exporter to the US	accessdata.fda.gov
Mouthpiece, Breathing	BYP	1	Exporter to the US	accessdata.fda.gov
Nasopharyngoscope (Flexible Or Rigid)	EOB	2	Exporter to the US	accessdata.fda.gov
Needle, Suturing, Disposable	GAB	1	Exporter to the US	accessdata.fda.gov
Neurological Stereotaxic Instrument	HAW	2	Exporter to the US	accessdata.fda.gov
Orthopedic Stereotaxic Instrument	OLO	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
Permanent Defibrillator Electrodes	NVY	3	Exporter to the US	accessdata.fda.gov
Permanent Pacemaker Electrode	DTB	3	Exporter to the US	accessdata.fda.gov
Photocoagulator And Accessories	HQB	2	Exporter to the US	accessdata.fda.gov
Powered Laser Surgical Instrument	GEX	2	Exporter to the US	accessdata.fda.gov
Probe, Radiofrequency Lesion	GXI	2	Exporter to the US	accessdata.fda.gov
Protector, Hearing (Insert)	EWD	U	Exporter to the US	accessdata.fda.gov
Pulse-Generator, Pacemaker, External	DTE	2	Exporter to the US	accessdata.fda.gov
Razor, Surgical	LWK	1	Exporter to the US	accessdata.fda.gov
Respirator, Surgical	MSH	2	Exporter to the US	accessdata.fda.gov
Restraint, Protective	FMQ	1	Exporter to the US	accessdata.fda.gov
Ring (Wound Protector), Drape Retention, Internal	KGW	2	Exporter to the US	accessdata.fda.gov
Screw, Fixation, Bone	HWC	2	Exporter to the US	accessdata.fda.gov
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	HOY	1	Exporter to the US	accessdata.fda.gov
Shunt, Central Nervous System And Components	JXG	2	Exporter to the US	accessdata.fda.gov
Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide	JKS	1	Exporter to the US	accessdata.fda.gov
Splint, Intranasal Septal	LYA	1	Exporter to the US	accessdata.fda.gov
Sponge, Ophthalmic	HOZ	2	Exporter to the US	accessdata.fda.gov
Staple, Implantable	GDW	2	Exporter to the US	accessdata.fda.gov
Stent, Ureteral	FAD	2	Exporter to the US	accessdata.fda.gov
Stents, Drains And Dilators For The Biliary Ducts	FGE	2	Exporter to the US	accessdata.fda.gov
Stimulator, Nerve	ETN	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
Syringe, Piston	FMF	2	Exporter to the US	accessdata.fda.gov
System, Blood Culturing	MDB	1	Exporter to the US	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Exporter to the US	accessdata.fda.gov
System, Imaging, Pulsed Doppler, Ultrasonic	IYN	2	Exporter to the US	accessdata.fda.gov
System, Imaging, Pulsed Echo, Ultrasonic	IYO	2	Exporter to the US	accessdata.fda.gov
Tape And Bandage, Adhesive	KGX	1	Exporter to the US	accessdata.fda.gov
Tourniquet, Pneumatic	KCY	1	Exporter to the US	accessdata.fda.gov
Transducer, Ultrasonic, Diagnostic	ITX	2	Exporter to the US	accessdata.fda.gov
Tray, Surgical, Needle	FSH	1	Exporter to the US	accessdata.fda.gov
Tube Tracheostomy And Tube Cuff	JOH	2	Exporter to the US	accessdata.fda.gov
Tube, Tracheostomy (W/Wo Connector)	BTO	2	Exporter to the US	accessdata.fda.gov
Tube, Tympanostomy	ETD	2	Exporter to the US	accessdata.fda.gov
Tubing, Noninvasive	GAZ	2	Exporter to the US	accessdata.fda.gov
Warmer, Blood, Non-Electromagnetic Radiation	BSB	2	Exporter to the US	accessdata.fda.gov
Wire, Guide, Catheter	DQX	2	Exporter to the US	accessdata.fda.gov
Wrap, Sterilization	FRG	2	Exporter to the US	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 157.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
June 14, 2024	K241250	3DMax Light Mesh	FTL	Substantially Equivalent	Davol Inc., Subsidiary of C. R. Bard, Inc.	accessdata.fda.gov
May 11, 2023	K220721	FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX CorAL 1000	KDI	Substantially Equivalent	Fresenius Medical Care Renal Therapies Group, LLC	accessdata.fda.gov
April 27, 2023	K230547	PlumePen Elite Surgical Smoke Evacuation Pencils, PlumePen Pro Surgical Smoke Evacuation Pencil, PlumePen Ultra Surgical Smoke Evacuation Pencils, PenAdapt Electrosurgical Pencil Adapter, SnapEvac Electrosurgical Pencil Adapter	GEI	Substantially Equivalent	Conmed Corporation	accessdata.fda.gov
February 16, 2023	K223766	NUVISION NAV Ultrasound Catheter	OBJ	Substantially Equivalent	Biosense Webster, Inc.	accessdata.fda.gov
November 25, 2020	K202066	EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled, Advisor FL Circular Mapping Catheter, Sensor Enabled, Advisor HD Grid High Density Mapping Catheter, Senor Enabled	DQK	Substantially Equivalent	ABBOTT MEDICAL	accessdata.fda.gov
November 2, 2020	K202552	Midas Rex Attachments and Dissecting Tools	OLO	Substantially Equivalent	Medtronic Powered Surgical Solutions (Mpss)	accessdata.fda.gov
July 31, 2020	K193237	Carto Octaray Mapping Catheter with Trueref Technology	MTD	Substantially Equivalent	Biosense Webster, Inc.	accessdata.fda.gov
July 29, 2020	K201361	PNEUMOCLEAR	HIF	Substantially Equivalent	W.O.M. World of Medicine GmbH	accessdata.fda.gov
March 28, 2019	K190303	AirSeal	HIF	Substantially Equivalent	Conmed Corporation	accessdata.fda.gov
October 24, 2018	K182281	Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech	IYO	Substantially Equivalent	C. R. Bard	accessdata.fda.gov
June 11, 2018	K173200	SOFIA Plus Aspiration Catheter	NRY	Substantially Equivalent	MicroVention, Inc.	accessdata.fda.gov
May 14, 2018	K173758	Disposable Biopsy Valve	OCX	Substantially Equivalent	Zhejiang Chuangxiang Medical Technology Co., Ltd.	accessdata.fda.gov
April 19, 2018	K180873	Medtronic Model 53401 External Pulse Generator (EPG)	DTE	Substantially Equivalent	Medtronic, Inc.	accessdata.fda.gov
November 21, 2017	K170754	3M Tegaderm Antimicrobial Transparent Dressing, 3M Tegaderm Antimicrobial I.V. Advanced Securement Dressing	FRO	Substantially Equivalent	3M Company, 3M Healthcare	accessdata.fda.gov
September 8, 2017	K171251	014 Hydrophilic Coated PTA Balloon Dilatation Catheter	LIT	Substantially Equivalent	Creagh Medical	accessdata.fda.gov
July 21, 2017	K170223	Progreat	DQO	Substantially Equivalent	Ashitaka Factory of Terumo Corporation	accessdata.fda.gov
July 3, 2017	K171267	NavLock Trackers	OLO	Substantially Equivalent	Medtronic Navigation	accessdata.fda.gov
May 25, 2017	K170242	MultiGen 2 RF Generator System	GXD	Substantially Equivalent	Stryker Corporation	accessdata.fda.gov
May 15, 2017	K170784	PNEUMOCLEAR	HIF	Substantially Equivalent	W.O.M. World of Medicine GmbH	accessdata.fda.gov
January 17, 2017	K161514	Precision Thin Reciprocating Blade, 0.010in.	EQJ	Substantially Equivalent	Stryker Corporation	accessdata.fda.gov
October 12, 2016	K162404	Express SD Biliary Monorail Premounted Stent System	FGE	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
September 30, 2016	K161232	ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit	BSO	Substantially Equivalent	Halyard Health	accessdata.fda.gov
July 28, 2016	K160339	Cardinal Health Isolation Gown	FYC	Substantially Equivalent	Cardinal Health200, LLC	accessdata.fda.gov
April 13, 2016	K160693	Neptune E-SEP Smoke Evacuation Pencil	GEI	Substantially Equivalent	Stryker Corporation	accessdata.fda.gov
March 31, 2016	K151932	Stryker CrossFlow Day-Use Inflow Cassette Tubing and Patient-Use Tubing	HRX	Substantially Equivalent	Stryker Corporation	accessdata.fda.gov
March 10, 2016	K151421	Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample Lines	CCK	Substantially Equivalent	Salter Labs	accessdata.fda.gov
February 25, 2016	K151866	BD BACTEC Peds Plus/F Culture Vials (plastic)	MDB	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
November 13, 2015	K152723	Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices	HIH	Substantially Equivalent	Hologic, Inc.	accessdata.fda.gov
June 18, 2015	K151356	Spacemaker Pro Access and Dissector System	GCJ	Substantially Equivalent	Covidien, LLC	accessdata.fda.gov
February 10, 2015	K142716	VCARE	LKF	Substantially Equivalent	Conmed Corporation	accessdata.fda.gov
December 18, 2014	K141712	KIMGUARD ONE STEP STERILIZATION WRAP	FRG	Substantially Equivalent	Halyard Health	accessdata.fda.gov
October 30, 2014	K142869	Premium Surgiclip III	FZP	Substantially Equivalent	Covidien	accessdata.fda.gov
October 23, 2014	K142876	ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound Systems	IYN	Substantially Equivalent	Siemens Medical Solutions USA, Inc.	accessdata.fda.gov
October 17, 2014	K142091	PARIETENE MACROPOROUS MESH	FTL	Substantially Equivalent	Sofradim Production	accessdata.fda.gov
October 17, 2014	K141344	EXPEL NEPHROURETERAL DRAINAGE STENT WITH TWIST-LOC HUB SYSTEM, EXPEL URETERAL DRAINAGE STENT SYSTEM	FAD	Substantially Equivalent	Boston Scientific Corp	accessdata.fda.gov
August 26, 2014	K141095	STRYKER STERI-SHIELD FLYTE HYBRID TOGAS	FYA	Substantially Equivalent	Stryker Corporation	accessdata.fda.gov
February 21, 2014	K133948	BARD(R) MONOPTY(R) DISPOSABLE CORE BIOPSY INSTRUMENT, BARD(R) MAX-CORE(R) DISPOSABLE CORE INSTRUMENT	KNW	Substantially Equivalent	Bard Peripheral Vascular, Inc.	accessdata.fda.gov
February 12, 2014	K130040	MEPITEL AG	FRO	Substantially Equivalent	Molnlycke Health Care	accessdata.fda.gov
December 20, 2013	K132671	STRYKER NEPTUNE 2 WASTE MANAGMENT SYSTEM	JCX	Substantially Equivalent	Stryker Corporation	accessdata.fda.gov
December 13, 2013	K132441	BARD VENTRALEX HERNIA PATCH	FTL	Substantially Equivalent	C.R. Bard, Inc.	accessdata.fda.gov
December 6, 2013	K133356	PROLENE POLYPROPYLENE NONABSORBABLE SUTURE	GAW	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
December 3, 2013	K132974	AQUAMANTYS 2.3 BIPOLAR SEALER, EVS 4.0 EPIDURAL VEIN SEALER, MINI EVS 3.4 EPIDURAL VEIN SEALER, SBS 5.0 SHEATHED BIPOLAR	GEI	Substantially Equivalent	Medtronic Advanced Energy, LLC	accessdata.fda.gov
November 27, 2013	K132658	HEMOCLIP TRADITIONAL LIGATING CLIPS, HEMOCLIP PLUS LIGATING CLIPS, HORIZON LIGTING CLIPS	FZP	Substantially Equivalent	Teleflex Medical	accessdata.fda.gov
November 14, 2013	K132614	PEREGRINE CURVED ILLUMINATING LASER PROBE	HQB	Substantially Equivalent	Peregrine Surgical , Ltd.	accessdata.fda.gov
October 30, 2013	K132357	SMITH & NEPHEW ULTRATAPE	GAT	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
August 23, 2013	K132054	GYNECARE TVT EXACT CONTINENCE SYSTEM	OTN	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
August 9, 2013	K123553	ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEM	KCY	Substantially Equivalent	Zimmer, Inc.	accessdata.fda.gov
April 5, 2013	K130782	ACCUMESH DEPLOYMENT SYSTEM	ORQ	Substantially Equivalent	Covidien, LLC	accessdata.fda.gov
March 18, 2013	K123546	3M ATTEST(TM) AUTO-READER	FRC	Substantially Equivalent	3M Company	accessdata.fda.gov
March 14, 2013	K130435	VERSAPORT V2 BLADELESS OPTICAL TROCAR	GCJ	Substantially Equivalent	Covidien, Formerly US Surgical A Divison of Tyco H	accessdata.fda.gov
February 28, 2013	K123679	3M TEGADERM CHG CHLORHEXIDINE GLUCONATE I.V. PORT DRESSING	FRO	Substantially Equivalent	3M Company	accessdata.fda.gov
January 9, 2013	K123441	STRYKER CROSSFLOW ARTHROSCOPY PUMP	HRX	Substantially Equivalent	Stryker Endoscopy	accessdata.fda.gov
November 20, 2012	K122596	ARTHROSCOPIC SURGICAL INSTRUMENTS - INTERFERENCE SCREW SYSTEMS	HWC	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
November 20, 2012	K122573	HI-TORQUE COMMAND GUIDE WIRE FAMILY	DQX	Substantially Equivalent	Abbott Vascular, Inc.	accessdata.fda.gov
October 23, 2012	K123109	ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE	GDW	Substantially Equivalent	Covidien	accessdata.fda.gov
October 18, 2012	K121861	SMITH & NEPHEW ULTRA FAST-FIX MENISCAL REPAIR SYSTEM, SMITH & NEPHEW ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEM, SMITH & N	GAT	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
October 1, 2012	K122511	ENDOPATH XCEL BLADELESS TROCAR WITH OPTIVIEW TECHNOLOGY ENDOPATH XCEL BLUNT TIP TROCAR WITH OPTIVIEW TECHNOLOGY ENDOPATH	GCJ	Substantially Equivalent	Ethicon Endo-Surgery, LLC	accessdata.fda.gov
November 23, 2011	K113163	PENUMBRA SYSTEM MAX	NRY	Substantially Equivalent	Penumbra, Inc.	accessdata.fda.gov
October 21, 2011	K110992	ENSPIRE DEBRIDER SYSTEM	HRX	Substantially Equivalent	Spine View, Inc.	accessdata.fda.gov
March 18, 2011	K102588	ACHIEVE MAPPING CATHETER AND ELECTRICAL CABLE	DRF	Substantially Equivalent	Medtronic Ablation Frontiers, LLC	accessdata.fda.gov
January 10, 2011	K103110	MINI TREK(TM) RX AND TREK(TM) RX CORONARY DILATATION CATHETER MINI TREK(TM) OTW AND TREK(TM) OTW DILATATION CATHETER	LOX	Substantially Equivalent	Abbott Vascular-Cardiac Therapies	accessdata.fda.gov
April 22, 2010	K100959	SPECIMEN RETRIEVAL SYSTEM	GCJ	Substantially Equivalent	Applied Medical Resources	accessdata.fda.gov
April 7, 2010	K093845	ETHICON SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE, MODEL STRAP25	GDW	Substantially Equivalent	ETHICON, Inc.	accessdata.fda.gov
January 28, 2010	K092508	FAST-FIX 360 MENISCAL REPAIR SYSTEM, STRIAGHT, CURVED, REVERSE CURVED,FAST FIX 360 AB MENISCAL REPAIR SYSTEM, STRAIGHT,	GAT	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
December 8, 2009	K092032	BARD PERFIX LIGHT PLUG, MODELS 0117050, 0117060, 0117070, 0117080, 0117150, 0117160	FTL	Substantially Equivalent	Davol Inc., Sub. C. R. Bard, Inc.	accessdata.fda.gov
December 4, 2009	K093199	3M COMPLY BOWIE- DICK TYPE LEAD FREE TEST PACK	JOJ	Substantially Equivalent	3M Company	accessdata.fda.gov
September 23, 2009	K091930	ANCHOR LAPAROSCOPIC TISSUE RETRIEVAL SYSTEM, MODEL TRS100SB	GCJ	Substantially Equivalent	Anchor Products Co.	accessdata.fda.gov
September 1, 2009	K091869	SILS CLINCHER, SILS DISSECTOR, SILS GRASPER, SILS L-HOOK, SILS SHEARS	GCJ	Substantially Equivalent	Covidien Lp, Formerly Registered AS United States	accessdata.fda.gov
July 9, 2009	K090165	RAINBOW RESPOSABLE PULSE CO-OXIMETER SENSORS, MODELS R2C-25, R2-25, R2C-20 AND R2-20	DQA	Substantially Equivalent	Masimo Corporation	accessdata.fda.gov
March 18, 2009	K090547	ULTRACLIP II US WING AND COIL, MODELS: 862017U, 864017U	NEU	Substantially Equivalent	C.R. Bard, Inc.	accessdata.fda.gov
August 27, 2008	K081275	BOSTON SCIENTIFIC SURGICAL MESH	PAH	Substantially Equivalent	Boston Scientific Corp	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
October 5, 2007	K072674	KII TROCAR SYSTEM	GCJ	Substantially Equivalent	Applied Medical Resources Corp.	accessdata.fda.gov
September 18, 2007	K072315	MIDAS REX CURVED BUR	HBE	Substantially Equivalent	Medtronic Powered Surgical Solutions	accessdata.fda.gov
June 29, 2007	K071066	SPYCATCH STONE RETRIEVAL BASKET	LQR	Substantially Equivalent	Boston Scientific Corp	accessdata.fda.gov
April 27, 2007	K063695	RUNTHROUGH NS	DQX	Substantially Equivalent	Terumo Medical Corp.	accessdata.fda.gov
March 23, 2007	K063005	STRYKER T6 HOODS AND TOGAS	FYA	Substantially Equivalent	Stryker Instruments	accessdata.fda.gov
February 23, 2007	K063023	3M HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK, MODEL 1870	MSH	Substantially Equivalent	3M Company	accessdata.fda.gov
October 13, 2006	K062895	XENON BRIGHTSTAR ILLUMINATION SYSTEM, MODEL 1266.XIII	MPA	Substantially Equivalent	Dutch Ophthalmic Research Center International BV	accessdata.fda.gov
September 6, 2006	K060623	SHORTSHOT SAEED HEMORRHOIDAL MULTI-BAND LIGATOR WITH TRIVIEW ANOSCOPE	FER	Substantially Equivalent	Cook Ireland, Ltd.	accessdata.fda.gov
August 31, 2006	K061313	EVIS EXERA 180 SYSTEM	EOQ	Substantially Equivalent	Olympus Medical Systems Corporation	accessdata.fda.gov
July 12, 2006	K061363	AGILIS NXT STEERABLE INTRODUCER	DYB	Substantially Equivalent	St Jude Medical	accessdata.fda.gov
November 7, 2005	K052638	ABBOTT SPINE, INC. SPINNAKER SYSTEM	KNW	Substantially Equivalent	Abbott Spine, Inc.	accessdata.fda.gov
May 4, 2005	K050813	ABC 2 SCREW	KWQ	Substantially Equivalent	Aesculap, Inc.	accessdata.fda.gov
March 31, 2005	K043418	COOK PEDIATRIC FLEXOR URETERAL ACCESS SHEALTH	FED	Substantially Equivalent	Cook Urological, Inc.	accessdata.fda.gov
August 26, 2004	K041711	ALEXIS WOUND RETRACTOR, MODELS C8312, C8301, C8302, C8303, C8304	KGW	Substantially Equivalent	Applied Medical Resources Corp.	accessdata.fda.gov
February 25, 2004	K033232	COLORADO MICRODISSECTION NEEDLE	GEI	Substantially Equivalent	Stryker Corp.	accessdata.fda.gov
February 5, 2004	K030837	40 L HIGH FLOW INSUFFLATOR F108	HIF	Substantially Equivalent	W.O.M. World of Medicine AG	accessdata.fda.gov
January 29, 2004	K033500	BD CAREFLOW CENTRAL VENOUS CATHETER	FOZ	Substantially Equivalent	Becton, Dickinson & CO	accessdata.fda.gov
January 16, 2004	K032303	STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM	HBE	Substantially Equivalent	Stryker Instruments	accessdata.fda.gov
August 13, 2003	K031616	IUR FLUID MANAGEMENT SYSTEM	HIG	Substantially Equivalent	W.O.M. World of Medicine AG	accessdata.fda.gov
March 7, 2003	K024061	PEREGRINE STRAIGHT LASER PROBE, MODEL PD6000.00	GEX	Substantially Equivalent	Peregrine Surgical , Ltd.	accessdata.fda.gov
February 13, 2003	K023012	SMARTSET HV BONE CEMENT	LOD	Substantially Equivalent	DePuy Orthopaedics, Inc.	accessdata.fda.gov
November 13, 2002	K023492	EVEREST BIPOLAR CUTTING FORCEPS AND GYRUS BIPOLAR CUTTING FORCEPS	GEI	Substantially Equivalent	Gyrus Medical, Inc.	accessdata.fda.gov
October 16, 2002	K022357	TRANSEND 300 ES GUIDEWIRE, MODEL 46-814 & TRANSEND 300 FLOPPY GUIDEWIRE, MODEL 46-815	DQX	Substantially Equivalent	Boston Scientific, Target	accessdata.fda.gov
September 25, 2002	K022100	NAVIGUS MANUAL DISPOSABLE MICRODRIVE WITH DIGITAL DISPLAY, MODELS MI-1000 & MI-1010	HAW	Substantially Equivalent	Image-Guided Neurologics, Inc.	accessdata.fda.gov
August 28, 2002	K020785	INTROCAN SAFETY IV CATHETER	FOZ	Substantially Equivalent	B.Braun Medical, Inc.	accessdata.fda.gov
May 17, 2002	K021256	Z3 GUIDE CATHETER	DQY	Substantially Equivalent	Medtronic Vascular	accessdata.fda.gov
January 22, 2002	K014165	STIMULUS - DISSECTION INSTRUMENTS	ETN	Substantially Equivalent	Medtronic Xomed, Inc.	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

PMA approvals

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

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
April 28, 2017	P160043	RESOLUTE ONYX ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM	NIQ	88	October 16, 2026	accessdata.fda.gov
March 29, 1996	P930039	MEDTRONIC(R) CAPSUREFIX LEAD MODEL 4068,4067,4568	NVN	267	June 24, 2026	accessdata.fda.gov

Compare with other makers

Updated October 16, 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.