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
166273–166296 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 26, 1980
HESSLER COLON THERAPY DEVICE
K800565 · KPL
Hessler Mfg. Co.
Gastroenterology & Urology · 105d
Cleared Jun 26, 1980
SILASTIC BRAND PERCUTANEOUS SKIN EXPANDE
K801042 · LCJ
Dow Corning Corp. Healthcare...
General & Plastic Surgery · 55d
Cleared Jun 26, 1980
V.I.B.E. VIDEO INTERFACE BIOFEEDBACK EQU
K801049 · HCC
Nebulae Productions
Neurology · 52d
Cleared Jun 26, 1980
PET-SCOPE II MODEL DIS-1611
K801166 · JAA
Diagnostic Information, Inc.
Radiology · 41d
Cleared Jun 26, 1980
KODAK MEDICAL X-RAY DEVELOPER & REPLEN.
K801209 · IXW
Eastman Kodak Company
Radiology · 37d
Cleared Jun 26, 1980
REAGENTS FOR ASTRA 8 AUTOMATED ANALYZER
K801222 · JIX
Simmler, Inc.
Chemistry · 34d
Cleared Jun 26, 1980
CAMBRIDGE CARDIAC DIAGNOSTIC SYSTEM
K801224 · DXK
Cambridge Instruments, Inc.
Cardiovascular · 35d
Cleared Jun 26, 1980
COBAS REAGENTS FOR URIC ACID
K801243 · CDO
Roche Analytical Instruments, Inc.
Chemistry · 30d
Cleared Jun 26, 1980
NUCLEAR ENTERPRISES 1600/GAMMA COUNTER
K801264 · JJJ
Nuclear Ent. , Ltd.
Toxicology · 29d
Cleared Jun 26, 1980
HI-TEMP SURGICAL CAUTERY
K801323 · GEI
Medical Products Development, Inc.
General & Plastic Surgery · 20d
Cleared Jun 26, 1980
ANSPACH OPERATING TABLE SUPPORT/SPINAL
K801326 · EPW
The Anspach Effort, Inc.
General & Plastic Surgery · 23d
Cleared Jun 26, 1980
ANSPACH LEG SUPPORT
K801330 · CCX
The Anspach Effort, Inc.
Anesthesiology · 23d
Cleared Jun 26, 1980
ARGYLE VAC-U-CARE FLAT SILICONE WOUND T.
K801371 · GCY
Sherwood Medical Co.
General & Plastic Surgery · 16d
Cleared Jun 26, 1980
ARGYLE VAC-U-CARE 100CC SUCT. RESERVOIR
K801372 · GCY
Sherwood Medical Co.
General & Plastic Surgery · 16d
Cleared Jun 26, 1980
PROXIMATE (TMD) TISSUE MEASURING DEVICE
K801374 · FTY
Ethicon, Inc.
General & Plastic Surgery · 16d
Cleared Jun 26, 1980
DISPOSABLE SURGICAL HEAD SUPPORT
K801382 · FSE
Innovative Surgical Products, Inc.
General & Plastic Surgery · 14d
Cleared Jun 26, 1980
ORTHOPEDIC LOWER EXTREMITY SUSPENSION
K801436 · FYH
Orthopedic Systems, Inc.
General Hospital · 7d
Cleared Jun 20, 1980
MACRO-VUE RUBELLA CARD TEST
K800797 · GOL
Bd Becton Dickinson Vacutainer...
Microbiology · 72d
Cleared Jun 20, 1980
LINEBERGER EXTERNAL MALE CATHETER
K800890 · KNX
Lineberger External Catheter Co.
Gastroenterology & Urology · 63d
Cleared Jun 20, 1980
A-GENT THYROZYME UPTAKE INHIBITOR ASSAY
K800911 · KHQ
Abbott Laboratories
Chemistry · 60d
Cleared Jun 20, 1980
URINARY CATHETER SAMPLING KIT
K800946 · KDT
Sage Products, Inc.
Pathology · 59d
Cleared Jun 20, 1980
STANBIO ACETAMINOPHEN TEST SET #0850
K801014 · LDP
Stanbio Laboratory
Toxicology · 53d
Cleared Jun 20, 1980
E-VAX CHEST DRAINAGE SYSTEM
K801043 · JCX
Cardio Surgical Concepts, Inc.
General & Plastic Surgery · 46d
Cleared Jun 20, 1980
COBAS REAGENT FOR AST (SGOT)
K801118 · CIT
Roche Analytical Instruments, Inc.
Chemistry · 39d