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
165193–165216 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 12, 1980
DISSCAP HOLLOW FIBER DIALYZER
K802466 · FJI
Hospal Medical Corp.
Gastroenterology & Urology · 35d
Cleared Nov 12, 1980
T4 RADIOIMMUNOASSAY KIT
K802469 · CDX
American Diagnostic Corp.
Chemistry · 34d
Cleared Nov 12, 1980
T3 RADIOIMMUNOASSAY KIT
K802470 · CDP
American Diagnostic Corp.
Chemistry · 34d
Cleared Nov 12, 1980
CHEMTROLER
K802471 · JQP
Fletcher Flora Computer Products, Inc.
Chemistry · 34d
Cleared Nov 12, 1980
BENZALKONIUM-HEPARIN COATED GUIDEWIRES
K802473 · DQX
Medrad, Inc.
Cardiovascular · 3d
Cleared Nov 12, 1980
LIGMAJECT
K802483 · EJI
Alan J. Khedarri D.D.S., Inc.
Dental · 34d
Cleared Nov 12, 1980
REIGNING CROWN BRIDGE
K802489 · EBG
Oki Shiks USA , Ltd.
Dental · 33d
Cleared Nov 12, 1980
REIGNING REPAIR EPOXY RESIN
K802491 · EBI
Oki Shiks USA , Ltd.
Dental · 33d
Cleared Nov 12, 1980
REIGNING ARTIFICIAL TEETH
K802492 · ELM
Oki Shiks USA , Ltd.
Dental · 33d
Cleared Nov 12, 1980
SPUTASOL
K802493 · IBG
Oxoid U.S.A., Inc.
Microbiology · 33d
Cleared Nov 12, 1980
GAS GENERATING KIT SYSTEM FOR CAMPYLOB.
K802494 · KZJ
Oxoid U.S.A., Inc.
Microbiology · 33d
Cleared Nov 12, 1980
OPTOCHIN DIAGNOSTIC DISC
K802496 · JTO
Oxoid U.S.A., Inc.
Microbiology · 33d
Cleared Nov 12, 1980
BACTIRACIN DIAGNOSTIC DISC
K802497 · JTO
Oxoid U.S.A., Inc.
Microbiology · 33d
Cleared Nov 12, 1980
MUELLER HINTON AGAR
K802498 · JTZ
Oxoid U.S.A., Inc.
Microbiology · 33d
Cleared Nov 12, 1980
X-FACTOR DISCS
K802500 · JTO
Oxoid U.S.A., Inc.
Microbiology · 33d
Cleared Nov 12, 1980
V FACTOR DISCS
K802501 · JTO
Oxoid U.S.A., Inc.
Microbiology · 33d
Cleared Nov 12, 1980
X & V FACTOR DISCS
K802502 · JTO
Oxoid U.S.A., Inc.
Microbiology · 33d
Cleared Nov 12, 1980
SPONGE SURGICAL GUAZE RADIOPAQUE
K802504 · EFQ
Barnhardt Mfg. Co.
General & Plastic Surgery · 28d
Cleared Nov 12, 1980
PLEASCENT OR FORMA-SCENT
K802506 · IGG
Meridian Diagnostics, Inc.
Pathology · 28d
Cleared Nov 12, 1980
G.R.A.M. SLIDE
K802509 · JTO
Sterilization Technical Services, Inc.
Microbiology · 28d
Cleared Nov 12, 1980
GARELICK COMMODE
K802511 · ILS
Garelick Mfg. Co.
Physical Medicine · 28d
Cleared Nov 12, 1980
ROOT CANAL POST
K802515 · ELR
Unitek Corp.
Dental · 28d
Cleared Nov 12, 1980
BUN REAGENT ASTRA 4 & 8 ANALYZERS
K802518 · CDN
Nobel Scientific Industries, Inc.
Toxicology · 28d
Cleared Nov 12, 1980
CENTRIFICHEM PIPETTOR ACCURACY CALIB.
K802520 · JQW
Union Carbide Corp.
Chemistry · 28d