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
162625–162648 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 20, 1981
HILL TOP CHAMBER
K811365 · KXF
Hill Top Research, Inc.
General Hospital · 98d
Cleared Aug 20, 1981
SUPERFIL LIGHT & SUPERFIL BONDING SYSTEM
K811427 · EBF
Harry J. Bosworth Co.
Dental · 90d
Cleared Aug 20, 1981
TENSMAX
K811499 · GZJ
Anritsu America Co.
Neurology · 85d
Cleared Aug 20, 1981
GORE-TEX VASULAR GRAFT
K811510 · DSY
W.L. Gore & Associates, Inc.
Cardiovascular · 85d
Cleared Aug 20, 1981
URIC ACID REAGENT SET
K811764 · LFQ
Anco Medical Reagents & Assoc.
Chemistry · 59d
Cleared Aug 20, 1981
BACTERICIDAL INCISE DRAPE
K811871 · KKX
Surgikos, Inc.
General Hospital · 50d
Cleared Aug 20, 1981
OSCILLAIRE
K812001 · BZC
Jones Medical Instrument Co.
Anesthesiology · 37d
Cleared Aug 20, 1981
MODEL S10VS VISUAL STIMULATOR
K812061 · GWE
Grass Instrument Co.
Neurology · 30d
Cleared Aug 20, 1981
BETA POST
K812092 · ELR
Paul B. Heller, D.M.D.
Dental · 28d
Cleared Aug 20, 1981
RENALAB TRANSDUCER PROTECTOR, .22 MICRON
K812107 · FIB
Renalab
Gastroenterology & Urology · 24d
Cleared Aug 20, 1981
LIFECARE 1000 CONTROLLER
K812114 · LDR
Abbott Laboratories
General Hospital · 24d
Cleared Aug 20, 1981
TENS DEVICE
K812138 · GZJ
Western Advanced Technology, Inc.
Neurology · 23d
Cleared Aug 20, 1981
VACUUM SUCTION FILTER
K812139 · KDQ
K & G Healthcare Ind., Inc.
General Hospital · 23d
Cleared Aug 20, 1981
BIRD MEAN AIRWAY PRESSURE MONITOR
K812140 · CAP
3M Company
Anesthesiology · 23d
Cleared Aug 20, 1981
MEDTRONIC #3484 PISCES EPIDURAL LEAD
K812154 · GZB
Medtronic Vascular
Neurology · 22d
Cleared Aug 20, 1981
CONCEP-7-BHCG
K812156 · JHI
Leeco Diagnostics, Inc.
Chemistry · 22d
Cleared Aug 20, 1981
EMIT-ST CANNABINOID ASSAY
K812195 · LDJ
Syva Co.
Toxicology · 17d
Cleared Aug 20, 1981
EMIT-ST CANNABINOID CONTROLS
K812196 · LAS
Syva Co.
Toxicology · 17d
Cleared Aug 20, 1981
EMIT-ST CANNABINOID CALIBRATOR
K812197 · DLJ
Syva Co.
Toxicology · 17d
Cleared Aug 20, 1981
CUDDLE CAP
K812216 · LDQ
Darcy, Inc.
General & Plastic Surgery · 15d
Cleared Aug 20, 1981
INTRAVENOUS ADMINISTRATION SET
K812231 · FPA
Cordis Corp.
General Hospital · 9d
Cleared Aug 20, 1981
COAT-A-COUNT T3 RIA KIT
K812246 · CDP
Diagnostic Products Corp.
Chemistry · 9d
Cleared Aug 20, 1981
CONDOM-52.XX
K812250 · KNX
Manfred Sauer Corp.
Gastroenterology & Urology · 9d
Cleared Aug 20, 1981
DISPOSABLE URINE GAB-70.XX
K812251 · KNX
Manfred Sauer Corp.
Gastroenterology & Urology · 9d