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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
97681–97704 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 22, 1996
NCI-H292 CELL CULTURE
K951461 · KIR
Viromed Laboratories, Inc.
Pathology · 419d
Cleared May 22, 1996
QUEST EXERCISE STRESS SYSTEM
K952417 · DSI
Burdick, Inc.
Cardiovascular · 365d
Cleared May 22, 1996
ET-TUBE PLACEMENT DETECTOR (WITH COLIBRI INDICATOR)
K954402 · CCK
Icor AB
Anesthesiology · 245d
Cleared May 22, 1996
CONSENSUS POSTERIOR STABILIZED KNEE
K954818 · JWH
U.S. Medical Products, Inc.
Orthopedic · 215d
Cleared May 22, 1996
DISCO UTERINE CONTRACTION TRANSDUCER & ACCESSORIES
K954847 · HFM
Ocg Systems, Inc.
Obstetrics & Gynecology · 212d
Cleared May 22, 1996
LAMINARIA
K955072 · HDY
Cti Corp., Ltd.
Obstetrics & Gynecology · 198d
Cleared May 22, 1996
STIM-8
K955736 · IPF
Bmr , Ltd.
Physical Medicine · 156d
Cleared May 22, 1996
MODEL 5471 & 5471L STERILE DISPOSABLE PATIENT CABLE ASSEMBLIES
K960446 · DSA
Medtronic Vascular
Cardiovascular · 111d
Cleared May 22, 1996
ONE STEP CONNECT LEADS (QUATTRODE, OCTRODE, CERVITRODE)
K960728 · GZB
Neuromed, Inc.
Neurology · 90d
Cleared May 22, 1996
MODEL 555 010 XY CONVERSION(55010)
K960737 · KPQ
Systems Supply Services, Inc.
Radiology · 89d
Cleared May 22, 1996
NATURE'S CRADLE MODEL C1500
K960747 · FMS
Infant Advantage, Inc.
General Hospital · 89d
Cleared May 22, 1996
MICRO21 WITH ANA
K960774 · JOY
Triangle Biomedical Sciences, Inc.
Hematology · 86d
Cleared May 22, 1996
VYGON DOUBLE LUMEN ENDOTRACHEAL TUBE
K960795 · BTR
Vygon Corp.
Anesthesiology · 85d
Cleared May 22, 1996
JACKSON-PRATT GOLD WOUND DRAINS WITH DURAFLO II COATING
K960955 · GBX
Baxter Healthcare Corp
General & Plastic Surgery · 72d
Cleared May 22, 1996
LASER PERIPHERALS INC. SCATTERFREE FIBER
K961079 · GEX
Laser Peripherals, LLC
General & Plastic Surgery · 65d
Cleared May 22, 1996
SPIRIT RIDGE SILICONE CARVING BLOCK
K961081 · MIB
Rand Scientific Corp.
General & Plastic Surgery · 65d
Cleared May 22, 1996
SOMNUS MEDICAL TECH SOFT TISSUE COAGULATING ELECTRODE
K961132 · GEI
Somnus Medical Technologies, Inc.
General & Plastic Surgery · 62d
Cleared May 22, 1996
DALL-MILES HOMOGENOUS VITALLIUM CABLE
K961283 · JDQ
Howmedica Corp.
Orthopedic · 49d
Cleared May 21, 1996
BACTEC(R) 9000TB SYSTEM
K946268 · MDB
Becton Dickinson Diagnostic...
Microbiology · 515d
Cleared May 21, 1996
HELISAL RAPID BLOOD TEST
K953686 · LYR
Cortecs, Ltd.
Microbiology · 295d
Cleared May 21, 1996
TERUMO RETRACTABLE NEEDLE (RN) SYRINGE
K953940 · FMF
Terumo Medical Corp.
General Hospital · 274d
Cleared May 21, 1996
U.S. ENDOSCOPY PULL PEG KIT & U.S. ENDOSCOPY GUIDEWIRE PEG KIT
K955248 · KNT
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 188d
Cleared May 21, 1996
VST-10, VST-10/2
K960433 · IPF
Vcare Intl., Inc.
Physical Medicine · 111d
Cleared May 21, 1996
MEDTRONIC MODEL 3550 ACCESSORY KIT (CONTENTS) 3550-OX
K960631 · GZF
Medtronic Vascular
Neurology · 97d