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
166297–166320 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 20, 1980
D300 DOME
K801136 · DRS
Gics Pharmaceuticals
Cardiovascular · 39d
Cleared Jun 20, 1980
PROXIMATE*(ILS) DISP. INTRALUMINAL STAP.
K801154 · GDW
Ethicon, Inc.
General & Plastic Surgery · 37d
Cleared Jun 20, 1980
STREPTO-SEC TM
K801159 · GTZ
Organon, Inc.
Microbiology · 40d
Cleared Jun 20, 1980
DIGOXIN RADIOIMMUNOASSAY KIT
K801202 · LCS
Technia Diagnostics , Ltd.
Toxicology · 32d
Cleared Jun 20, 1980
EMIT VALPROIC ACID ASSAY
K801207 · LEG
Syva Co.
Toxicology · 32d
Cleared Jun 20, 1980
TRIGLYCERIDES FOR SMA AND AAII
K801226 · CDT
Reagents Applications, Inc.
Chemistry · 29d
Cleared Jun 20, 1980
REIGNING ARTIFICIAL TEETH/POLYCARB.RESIN
K801235 · ELM
Oki Shiks USA , Ltd.
Dental · 24d
Cleared Jun 20, 1980
COBAS REAGENT FOR ALKALINE PHOSPHATASE
K801242 · CJE
Roche Analytical Instruments, Inc.
Chemistry · 24d
Cleared Jun 20, 1980
ROCHE HCG STANDARDS
K801244 · JHI
Hoffmann-La Roche, Inc.
Chemistry · 24d
Cleared Jun 20, 1980
ATOMLIGHT (LIQUID SCINTILLATION SOLUTION
K801245 · JJJ
New England Nuclear
Toxicology · 24d
Cleared Jun 20, 1980
NUCLEAR ENTERPRISES 1612 MULTI-WELL
K801263 · JJJ
Nuclear Ent. , Ltd.
Toxicology · 23d
Cleared Jun 20, 1980
DUPONT PREP APPLI. FOR PHENOBARBITAL,
K801276 · DKH
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 23d
Cleared Jun 20, 1980
J.T. BAKER IMMUNOGLOBULIN G NEPHELOMETRI
K801281 · DEW
J.T. Baker Chemical Co.
Immunology · 22d
Cleared Jun 20, 1980
SURGICAL INSTRUMENTS
K801292
William Skidmore & Co., Ltd.
General & Plastic Surgery · 18d
Cleared Jun 20, 1980
GOLDEN THERMAL RHINOPLASTY CAST BANDAGE
K801301 · ILO
Auric, Inc.
Physical Medicine · 17d
Cleared Jun 20, 1980
FIAX TEST KIT FOR TOBRAMYCIN QUANTITA
K801308 · LCR
Intl. Diagnostic Technology
Toxicology · 17d
Cleared Jun 20, 1980
RITTER STERILIZER
K801309 · FLE
Sybron Corp.
General Hospital · 17d
Cleared Jun 20, 1980
THE MAGTEC SYSTEM
K801310
Valley Forge Scientific Corp.
General & Plastic Surgery · 17d
Cleared Jun 20, 1980
AMPCO SKIN SCRUB TRAYS
K801332 · FRG
Associated Medical Products Co.
General Hospital · 17d
Cleared Jun 20, 1980
B-D FILTER NEEDLE
K801343 · FPB
Bd Becton Dickinson Vacutainer...
General Hospital · 15d
Cleared Jun 20, 1980
MODEL 336B HEARING AID
K801367 · ESD
Communications, Inc.
Ear, Nose, Throat · 10d
Cleared Jun 17, 1980
SOLARIUM, MODEL 6040A
K800366
Blendette Intl. , Ltd.
Radiology · 118d
Cleared Jun 17, 1980
CO2 CYSTOSCOPY/URETHROSCOPY CONSOLE
K800822 · FAP
Kli
Gastroenterology & Urology · 64d
Cleared Jun 17, 1980
MEDEFOAM-2
K800840 · KTA
Medefield Pty. , Ltd.
Radiology · 63d