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
82993–83016 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 14, 2000
SECCA TUBULAR ELECTRODE DEVICE, MODEL A4000
K000170 · GEI
Conway Stuart Medical, Inc.
General & Plastic Surgery · 27d
Cleared Feb 14, 2000
GORE-TEX DUALMESH PLUS BIOMATERIAL (1 MM & 2MM)
K000185 · FTL
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 25d
Cleared Feb 14, 2000
NIPRO BLOOD COLLECTION NEEDLE
K992699 · FMI
Nipro Medical Corp.
General Hospital · 186d
Cleared Feb 14, 2000
LCV+ VERSION 2
K993037 · OWB
Ge Medical Systems, Inc.
Radiology · 158d
Cleared Feb 14, 2000
REMED MALE LATEX CONDOM (SUPER DUPER) PREVENTOR, LUCKY BOY, AND SUMMIT
K993390 · HIS
Remed Pharma
Obstetrics & Gynecology · 129d
Cleared Feb 14, 2000
GENX CULTURE DISH
K993881 · MQK
Intl., Inc.
Obstetrics & Gynecology · 90d
Cleared Feb 14, 2000
GENX MICROTOOLS
K993884 · MQJ
Intl., Inc.
Obstetrics & Gynecology · 90d
Cleared Feb 14, 2000
WHITESIDE BIOMECHANICS TITANIUM LOW-PROFILE CABLE, MODEL BIO-1-1013
K993903 · JDQ
Whiteside Biomechanics, Inc.
Orthopedic · 90d
Cleared Feb 14, 2000
IDX-60 INTRAORAL X-RAY
K993958 · MUH
X-Cel X-Ray Corp.
Radiology · 84d
Cleared Feb 14, 2000
ISOCENTRIC BEAM CHECKER
K993959 · IYE
Mick Radio-Nuclear Instruments, Inc.
Radiology · 84d
Cleared Feb 14, 2000
PERMA-DOC PHANTOM
K993960 · IYE
Mick Radio-Nuclear Instruments, Inc.
Radiology · 84d
Cleared Feb 14, 2000
VEIN ENTRY INDICATOR DEVICE (VEID)
K993995 · FMF
Vascular Technologies , Ltd.
General Hospital · 82d
Cleared Feb 14, 2000
ISSA PHAROS
K994054 · LLZ
Vams Tec, D.O.O.
Radiology · 76d
Cleared Feb 14, 2000
LOCON-T DISTAL RADIAL PLATE
K994061 · HRS
Wrightmedicaltechnologyinc
Orthopedic · 75d
Cleared Feb 14, 2000
MAGNA 5000 PHASED ARRAY CTL SPINE COIL
K994345 · MOS
Usa Instruments, Inc.
Radiology · 53d
Cleared Feb 11, 2000
NIPRO INSULIN SYRINGE
K000144 · FMF
Nipro Medical Corp.
General Hospital · 24d
Cleared Feb 11, 2000
AUDIOSCREENER OAE
K000184 · EWO
Kedly, Inc.
Ear, Nose, Throat · 22d
Cleared Feb 11, 2000
CARD GUARD PERSONAL ELECTROCARDIOGRAM TRANSMITTER, MODEL CG-6206/6306
K000225 · DXH
Card Guard Scientific Survival , Ltd.
Cardiovascular · 18d
Cleared Feb 11, 2000
CAP PORP, CAP TORP
K000256 · ETB
Gyrus Ent LLC
Ear, Nose, Throat · 14d
Cleared Feb 11, 2000
KODAK HOME HEALTH MONITORING SYSTEM
K983928 · MWI
Eastman Kodak Company
Cardiovascular · 463d
Cleared Feb 11, 2000
TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR SE-30 TENS
K991397 · GZJ
Sein Electronics Co., Ltd.
Neurology · 296d
Cleared Feb 11, 2000
T-GEAR, MODEL TG/400-700
K993224 · DZB
Dontech Products B.V.
Dental · 137d
Cleared Feb 11, 2000
CAVERMAP SURGICAL AID
K993436 · FGM
Uromed Corp.
Gastroenterology & Urology · 122d
Cleared Feb 11, 2000
GASTRO-INTESTINAL SYSTEM EN-410WM
K993704 · FDA
Fujinon, Inc.
Gastroenterology & Urology · 101d