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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
71521–71544 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 22, 2003
SMITH & NEPHEW PROFIX TOTAL KNEE SYSTEM
K030623 · MBH
Smith & Nephew, Inc.
Orthopedic · 84d
Cleared May 22, 2003
DRI COTININE EIA ASSAY
K030649 · MRS
Microgenics Corp.
Toxicology · 83d
Cleared May 22, 2003
'RAPID ONE' - PROPOXYPHENE TEST
K030835 · JXN
American Bio Medica Corp.
Toxicology · 66d
Cleared May 22, 2003
COAGUCHEK PT.S TEST FOR PROTHROMBIN TIME SELF-TESTING
K030845 · GJS
Roche Diagnostics Corp.
Hematology · 66d
Cleared May 22, 2003
THERMACOOL TC SYSTEM
K031046 · GEI
Thermage, Inc.
General & Plastic Surgery · 50d
Cleared May 22, 2003
APEX MODULAR ACETABULAR CUP
K031110 · LPH
Apex Surgical, LLC
Orthopedic · 44d
Cleared May 22, 2003
MODEL 5071 MYOCARDIAL PACING LEAD
K031274 · DTB
Medtronic Vascular
Cardiovascular · 30d
Cleared May 22, 2003
MODIFICATION TO FOSSA URETERAL STONE SWEEPER
K031292 · FAD
Fossa Medical, Inc.
Gastroenterology & Urology · 29d
Cleared May 22, 2003
SMART 2940 D ER: YAG LASER
K031317 · GEX
Cynosure, Inc.
General & Plastic Surgery · 27d
Cleared May 22, 2003
TEXAS T - PLATE
K031334 · HRS
Biomet, Inc.
Orthopedic · 24d
Cleared May 22, 2003
DYONICS VISION 325Z DV3-CCD HERMES READY CAMERA SYSTEM, MODEL 7209531
K031379 · GCJ
Smith & Nephew, Inc.
General & Plastic Surgery · 21d
Cleared May 22, 2003
MODIFICATION TO HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEM
K031388 · CGA
Hypoguard USA, Inc.
Chemistry · 20d
Cleared May 22, 2003
DIGNITY OPHTHALMIC SURGICAL SYSTEM
K031404 · HQC
Phacor Inc., A Santen Company
Ophthalmic · 17d
Cleared May 22, 2003
CEMEX SYSTEM FAST
K031430 · LOD
Exactech, Inc.
Orthopedic · 16d
Cleared May 22, 2003
AQUILION SUPER 4 MULTISLICE CT SCANNER, MODEL TSX-101A/7
K031469 · JAK
Toshiba America Medical Systems, In.C
Radiology · 13d
Cleared May 22, 2003
EOPA CAP ELONGATED ONE-PIECE ARTERIAL CANNULA WITH PRESSURE MONITORING LINE,...
K031518 · DWF
Medtronic Vascular
Cardiovascular · 7d
Cleared May 21, 2003
VARISEED 7.1
K030534 · KXK
Varian Medical Systems
Radiology · 90d
Cleared May 21, 2003
RFX FLUROSCOPIC DIGITAL IMAGING SYSTEM
K030544 · OWB
Sigma Vision, Inc.
Radiology · 90d
Cleared May 21, 2003
MAMMOSITE RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER...
K030558 · JAQ
Proxima Therapeutics, Inc.
Radiology · 89d
Cleared May 21, 2003
ANSPACH IRRIGATION PUMP AND IRRIGATION PUMP II
K030576 · FRN
The Anspach Effort, Inc.
General Hospital · 86d
Cleared May 21, 2003
MODIFICATION TO NUMED TYSHAK II AND Z-MED II PTV CATHETERS
K030589 · DQY
NuMED, Inc.
Cardiovascular · 85d
Cleared May 21, 2003
PT2 GUIDE WIRE AND ADDWIRE EXTENSION WIRE
K030617 · DQX
Boston Scientific Scimed, Inc.
Cardiovascular · 84d
Cleared May 21, 2003
MYTHOS 500
K030805 · GEX
Msq (M2) , Ltd.
General & Plastic Surgery · 69d
Cleared May 21, 2003
DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-AN03 AND L-ANE03A SOFTWARE
K030812 · MHX
Datex-Ohmeda
Cardiovascular · 68d