FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
121297–121320 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 04, 1991
ELECTRO-NERVE STIMULATOR TENS MODEL BIOMED 2000/A
K905570 · GZJ
Biomedical Life Systems, Inc.
Neurology · 174d
Cleared Jun 04, 1991
CONDOMS (RUBBER CONTRACEPTIVES)
K910284 · HIS
Suretex, Ltd.
Obstetrics & Gynecology · 132d
Cleared Jun 04, 1991
INVOTEC X-RAY CASSETTE EQUIPMENT DRAPE
K911041 · IXA
Invotec International, Inc.
Radiology · 88d
Cleared Jun 04, 1991
PALMAZ(TM) BALLOON-EXPANDABLE STENT, MODIFICATION
K911581 · FGE
Johnson & Johnson Interventional Systems
Gastroenterology & Urology · 56d
Cleared Jun 03, 1991
NASCOR OXYDOME
K905627 · BYL
Nascor Pty. , Ltd.
Anesthesiology · 171d
Cleared Jun 03, 1991
CHARISMA
K910263 · EBF
Kulzer, Inc.
Dental · 132d
Cleared Jun 03, 1991
STABIDENT LOCAL ANESTHESIA SYSTEM
K910446 · DZM
Fairfax Dental, Inc.
Dental · 140d
Cleared Jun 03, 1991
CONDOMS/SAXON, GOLD CIRCLE COIN, EMBRACE & RAINBOW
K910550 · HIS
Safetex Corp.
Obstetrics & Gynecology · 116d
Cleared Jun 03, 1991
VERSACATH(TM) SELECTALUMEN(TM) W/CONVERSION TRAY
K910565 · FOZ
Menlo Care, Inc.
General Hospital · 115d
Cleared Jun 03, 1991
VERSACATH(TM) MULTILUMEN SYSTEM
K910566 · FOZ
Menlo Care, Inc.
General Hospital · 115d
Cleared Jun 03, 1991
SPENCIO SKIN GUARD KIT
K910927 · KMF
Spenco Medical Corp.
General & Plastic Surgery · 90d
Cleared Jun 03, 1991
OLYMPUS ANGIOSCOPY IRRIGATION SHEATH
K910933 · DYB
Olympus Corp.
Cardiovascular · 89d
Cleared Jun 03, 1991
NEV-10 NEGATIVE PRESSURE VENTILATOR
K910947 · BYT
Lifecare Services, Inc.
Anesthesiology · 89d
Cleared Jun 03, 1991
INVOTEC MICROSCOPE DRAPE
K911040 · HMW
Invotec International, Inc.
General Hospital · 87d
Cleared Jun 03, 1991
CIRCON ACMI HYDROLAPAROSCOPE(TM) INSTRUMENT
K911053 · GCJ
Circon Video
General & Plastic Surgery · 87d
Cleared Jun 03, 1991
NORCATH VASCULAR ACCESS CATHETERS
K911067 · LJS
Norfolk Medical
General Hospital · 84d
Cleared Jun 03, 1991
IMAGYN MEDICAL VIDEOSCOPY SYST W/IRRIG PUMP/ACCESS
K911163 · FWF
Imagyn Medical, Inc.
General & Plastic Surgery · 80d
Cleared Jun 03, 1991
SYNERMED UREA NITROGEN REAGENT KIT
K911248 · CDQ
Synermed, Inc.
Chemistry · 74d
Cleared Jun 03, 1991
CROSSFIRE LASER ASSISTED ASPIRATION CANNULA
K911408 · GEX
Heraeus Lasersonics, Inc.
General & Plastic Surgery · 63d
Cleared Jun 03, 1991
TRUMPET VALVE
K911415 · FMG
B. Braun of America, Inc.
General Hospital · 63d
Cleared Jun 03, 1991
ACA(R) URINE PHENCYCLIDINE (U PCP) SCREEN METHOD
K911725 · LCM
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 47d
Cleared Jun 03, 1991
RATEMINDER(TM) V INFUSION PUMP, MODIFICATION
K911769 · FRN
Critikon Company, LLC
General Hospital · 45d
Cleared Jun 03, 1991
INTERFLO MEDICAL MODEL PA3-H CCO/PAC CATHETER
K911840 · DYG
Intec Medical, Inc.
Cardiovascular · 39d
Cleared Jun 03, 1991
DASH MEDICAL GLOVES
K912038 · LYY
Safehealth Labs
General Hospital · 26d