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
126625–126648 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 27, 1990
MESALT STERILE DRESSING
K897142 · FRO
Scott Health Care
General & Plastic Surgery · 90d
Cleared Mar 27, 1990
CALIBRATORS, CONTROL MATERIALS, ELECTRODES & TUBE
K897177 · JIX
Nova Biomedical Corp.
Chemistry · 90d
Cleared Mar 27, 1990
L.T.C. PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE
K897181 · FPD
Intl. Medical Marketing, Inc.
Gastroenterology & Urology · 89d
Cleared Mar 27, 1990
KETAC-CEM MAXICAP
K897188 · EMA
Espe GmbH (Us)
Dental · 89d
Cleared Mar 27, 1990
ADVANCE STOPCOCKS ADVANCE MANIFOLDS
K897196 · DTL
Advance Medical Designs, Inc.
Cardiovascular · 88d
Cleared Mar 27, 1990
LIFECARE(R) 175 INFUSER
K900057 · FRN
Abbott Laboratories
General Hospital · 83d
Cleared Mar 27, 1990
NIDEK, INC. MODELS YC-1100 OPHTHALMIC LASERS
K900166 · GEX
Nidek, Inc.
General & Plastic Surgery · 74d
Cleared Mar 27, 1990
LASAG MICRORUPTER 2 ND:YAG LASER TRABECULOPLASTY
K900199 · HQF
Lasag AG
Ophthalmic · 70d
Cleared Mar 27, 1990
LATEX EXAM GLOVES (SHANGHAI RONGTONG LATEX GLOVES)
K900352 · LYY
Sinochem (Usa), Inc.
General Hospital · 63d
Cleared Mar 27, 1990
SHARPLAN MODEL 1055 SEALED CO2 SURGICAL LASER
K900592 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 48d
Cleared Mar 27, 1990
REXTON PP 142, PP 142-L
K900636 · ESD
Rexton, Inc.
Ear, Nose, Throat · 46d
Cleared Mar 27, 1990
U.V. SUNLAMP (U.V. LIGHT, DERMATOLOGIC)
K900693 · FTC
Light Sources, Inc.
General & Plastic Surgery · 42d
Cleared Mar 27, 1990
ZZIPP INSTANT BOVIE CLEANER
K900714 · GEI
Grieshaber & Co.
General & Plastic Surgery · 41d
Cleared Mar 27, 1990
HEPARIN CONTROL PLASMA, FOR USE IN APTT
K900782 · GGC
Medical Diagnostic Technologies, Inc.
Hematology · 35d
Cleared Mar 27, 1990
RISTOCETIN
K900792 · GHR
Medical Diagnostic Technologies, Inc.
Hematology · 35d
Cleared Mar 27, 1990
PROTEX LATEX EXAMINATION GLOVES
K900933 · LYY
Seyen Intl., Inc.
General Hospital · 27d
Cleared Mar 27, 1990
INTRAVENOUS STAND OR IV STAND
K900981 · FOX
Travl-Med Infusion Device Transport...
General Hospital · 25d
Cleared Mar 27, 1990
NUDA (CURRENTLY CALLED ULTRA SENSITIVE)
K901111 · HIS
Ansell, Inc.
Obstetrics & Gynecology · 18d
Cleared Mar 27, 1990
G.S.A. COLORED CONDOMS
K901112 · HIS
Ansell, Inc.
Obstetrics & Gynecology · 18d
Cleared Mar 26, 1990
TEMPTEK T-1000 THERAPEUTIC COOLING UNIT
K891091 · ILO
Temptek, Inc.
Physical Medicine · 389d
Cleared Mar 26, 1990
ANSELL CONFORM GREEN EXAMINATION GLOVES
K897081 · LYZ
Ansell, Inc.
General Hospital · 97d
Cleared Mar 26, 1990
PURITAN-BENNETT COMPANION 2801 VOLUME VENTILATOR
K897113 · CBK
Puritan Bennett Corp.
Anesthesiology · 90d
Cleared Mar 26, 1990
CVIS INSIGHT IMAGING CATHETER
K897153 · LYK
Cardiovascular Imaging Systems, Inc.
Cardiovascular · 90d
Cleared Mar 26, 1990
ISOTRON 220
K900823 · IPF
Excel Tech. , Ltd.
Physical Medicine · 34d