Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
167113–167136 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 30, 1980
CARDIOPULMONARY BYPASS TUBING
K801401 · DWF
Texas Medical Products, Inc.
Cardiovascular · 17d
Cleared Jun 30, 1980
QUICKIE PRIME CARDIOP. BYPASS PERF. INTR
K801402 · DTL
Texas Medical Products, Inc.
Cardiovascular · 17d
Cleared Jun 30, 1980
DISPOSABLE PERFUSION SET
K801403 · DWF
Texas Medical Products, Inc.
Cardiovascular · 17d
Cleared Jun 30, 1980
DISPOSABLE PARALLEL Y CONNECTORS
K801404 · DTL
Texas Medical Products, Inc.
Cardiovascular · 17d
Cleared Jun 30, 1980
DISPOSABLE PERFUSION CONNECTORS
K801405 · DTL
Texas Medical Products, Inc.
Cardiovascular · 17d
Cleared Jun 26, 1980
MEDTRONIC MODELS 5966/5967, ETC.
K800069 · DXY
Medtronic Vascular
Cardiovascular · 167d
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