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
157993–158016 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 07, 1983
GORE-TEX BARRIER SURG. DRAPES & GOWNS
K822641 · KKX
W.L. Gore & Associates, Inc.
General Hospital · 128d
Cleared Jan 07, 1983
101M IN-THE-EAR
K823073 · ESD
Danavox, Inc.
Ear, Nose, Throat · 80d
Cleared Jan 07, 1983
SPUNGUARD FACE MASK
K823078 · FXX
Kimberly-Clark Corp.
General Hospital · 80d
Cleared Jan 07, 1983
SAY
K823118 · ESE
Kells Medical, Inc.
Ear, Nose, Throat · 78d
Cleared Jan 07, 1983
TEL-STAR NU-WAY & GENERIC E
K823178 · ESD
Omni Hearing Systems
Ear, Nose, Throat · 73d
Cleared Jan 07, 1983
ESTROCEPT STABILIZED ESTROGEN RECEPTOR
K823186 · JJX
Brl
Chemistry · 73d
Cleared Jan 07, 1983
INTERFACE TRANSFUSION BLOOD FILTER #30
K823261 · CAK
Medical, Inc.
General Hospital · 66d
Cleared Jan 07, 1983
COBE HEMOCONCENTRATOR 1.3
K823338 · KDI
Cobe Laboratories, Inc.
Gastroenterology & Urology · 60d
Cleared Jan 07, 1983
INSTRA-SAFE
K823430 · FSM
Instranetics, Inc.
General & Plastic Surgery · 52d
Cleared Jan 07, 1983
BIRT-A-SWITCH DSP #712
K823491 · GEI
Birtcher Corp.
General & Plastic Surgery · 45d
Cleared Jan 07, 1983
WRIGHT CARE
K823497 · GZJ
Dow Corning Wright
Neurology · 45d
Cleared Jan 07, 1983
CENTRAL SUPPLY ROOM WRAP
K823513 · FRG
James River Corp.
General Hospital · 39d
Cleared Jan 07, 1983
CK-ISOZYME U.V. REAGENT SET
K823550 · JHT
Gelman Sciences, Inc.
Chemistry · 38d
Cleared Jan 07, 1983
URETHRAL PRESSURE PROFILE & TEMP. MODUL
K823561 · FAP
Nihon Kohden America, Inc.
Gastroenterology & Urology · 36d
Cleared Jan 07, 1983
COBAS STANDARDS FOR CREATININE
K823572 · CGX
Hoffmann-La Roche, Inc.
Chemistry · 32d
Cleared Jan 07, 1983
COBAS REAGENT FOR CREATININE
K823573 · CGX
Hoffmann-La Roche, Inc.
Chemistry · 32d
Cleared Jan 07, 1983
COBAS REAGENT FOR ALBUMIN
K823574 · CIX
Hoffmann-La Roche, Inc.
Chemistry · 32d
Cleared Jan 07, 1983
COBAS STANDARDS FOR ALBUMIN
K823575 · CIX
Hoffmann-La Roche, Inc.
Chemistry · 32d
Cleared Jan 07, 1983
COBAS STANDARD FOR TOTAL PROTEIN
K823576 · LER
Hoffmann-La Roche, Inc.
Chemistry · 32d
Cleared Jan 07, 1983
COBAS REAGENT FOR CALCIUM
K823577 · CIC
Hoffmann-La Roche, Inc.
Chemistry · 32d
Cleared Jan 07, 1983
COBAS STANDARDS FOR CALCIUM-IN-ORGANIC
K823578 · CIO
Hoffmann-La Roche, Inc.
Chemistry · 32d
Cleared Jan 07, 1983
COBAS REAGENT FOR TOTAL PROTEIN
K823579 · CEK
Hoffmann-La Roche, Inc.
Chemistry · 32d
Cleared Jan 07, 1983
COBAS REAGENT FOR INORGANIC PHOSPHORUS
K823580 · CEO
Hoffmann-La Roche, Inc.
Chemistry · 32d
Cleared Jan 07, 1983
NML 6000 CT
K823679 · JQP
Nuclear Medical Laboratories, Inc.
Chemistry · 31d