FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
93337–93360 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 09, 1997
DISPOSABLE PATIENT RETURN ELECTRODE
K972269 · GEI
Erbe USA, Inc.
General & Plastic Surgery · 22d
Cleared Jul 08, 1997
KAR
K961732 · MEH
Landos, Inc.
Orthopedic · 431d
Cleared Jul 08, 1997
RMI HEMOCONCENTRATOR PREFERENCE PACK
K970739 · KDI
Research Medical, Inc.
Gastroenterology & Urology · 130d
Cleared Jul 08, 1997
DISK WHISK CUTTING DEVICE (CONICAL, ELLIPTICAL AND BALL HEAD)
K971342 · HWE
Disk Whisk, Inc.
Orthopedic · 89d
Cleared Jul 08, 1997
KINEMATIC ALL-POLYETHYLENE PATELLA WITH THREE PEGS
K971550 · JWH
Howmedica Corp.
Orthopedic · 71d
Cleared Jul 08, 1997
FAR-EAST BARRIER GOWNS
K971702 · FYC
Far East Science & Technology...
General Hospital · 61d
Cleared Jul 08, 1997
X-RAY ASSIST BAR
K972000 · KPR
Ralph Lindel, D.C.
Radiology · 39d
Cleared Jul 08, 1997
NICAS(TM) ELECTRODE
K972001 · DRX
Ni Medical
Cardiovascular · 39d
Cleared Jul 08, 1997
NASAL AIRWAY SPLINT
K972092 · LYA
Boston Medical Products, Inc.
Ear, Nose, Throat · 34d
Cleared Jul 08, 1997
QUALITROL UNASSAYED H. PYLORI CONTROL SET POSITIVE AND NEGATIVE CONTROLS
K972146 · LYR
Consolidated Technologies, Inc.
Microbiology · 29d
Cleared Jul 08, 1997
TBD
K972273 · GEI
Megadyne Medical Products, Inc.
General & Plastic Surgery · 20d
Cleared Jul 07, 1997
CAPIOX 308 HOLLOW FIBER OXYGENATOR W/INTEGRATED HEAT EXCHANGE
K961734 · DTZ
Terumo Medical Corp.
Cardiovascular · 430d
Cleared Jul 07, 1997
EPILIGHT HAIR REMOVAL SYSTEM
K963249 · GEX
Esc Medical Systems , Ltd.
General & Plastic Surgery · 322d
Cleared Jul 07, 1997
MANUAL RESUSCITATOR
K963848 · BTM
Owens-Brigam Medical Co.
Anesthesiology · 285d
Cleared Jul 07, 1997
OCULAR CONFORMER
K970318 · HQN
Southwest Artificial Eyes, Inc.
Ophthalmic · 160d
Cleared Jul 07, 1997
OCULAR CONFORMER
K970319 · HQN
Xavier A. Guerra, Ocularist, Inc.
Ophthalmic · 160d
Cleared Jul 07, 1997
SCLERAL SHELL
K970320 · HQT
Xavier A. Guerra, Ocularist, Inc.
Ophthalmic · 160d
Cleared Jul 07, 1997
SCLERAL SHELL
K970327 · HQT
Southwest Artificial Eyes, Inc.
Ophthalmic · 160d
Cleared Jul 07, 1997
CMS CRYOLITE
K970995 · GEH
Cryomedical Sciences, Inc.
General & Plastic Surgery · 110d
Cleared Jul 07, 1997
PRECINORM TDM CONTROLS
K971060 · DIF
Boehringer Mannheim Corp.
Chemistry · 105d
Cleared Jul 07, 1997
ULTRACISION 5MM LAPAROSONIC HOOK BLADES, ULTRACISION HS2 BLADE
K971302 · LFL
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 90d
Cleared Jul 07, 1997
BIOSIGN STREP A - DIRECT STREP A ANTIGEN TEST
K971349 · GTY
Princeton BioMeditech Corp.
Microbiology · 88d
Cleared Jul 07, 1997
IVALON INSTRUMENT WIPE, IVALON KNIFE CLEANING BLOCK
K971473 · GEC
M-Pact Worldwide Management Corp.
General & Plastic Surgery · 75d
Cleared Jul 07, 1997
DOYLE COMBO NASAL AIRWAY SPLINT
K972151 · LYA
Boston Medical Products, Inc.
Ear, Nose, Throat · 28d