FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
72025–72048 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 23, 2003
ENDOSCOPIC PLICATION SYSTEM, MODEL 160-00760
K031262 · ODE
Ndo Surgical, Inc.
Gastroenterology & Urology · 32d
Cleared May 23, 2003
RANFAC GOLDENBERG SNARECOIL SOFT TISSUE BIOPSY (GSS) NEEDLE
K031344 · KNW
Ranfac, Corp.
Gastroenterology & Urology · 24d
Cleared May 23, 2003
CADD HIGH-VOLUME ADMINISTRATION SETS WITH FLOWSTOP
K031361 · FPA
Deltec, Inc.
General Hospital · 23d
Cleared May 23, 2003
SAPHYRE BIPOLAR ABLATION PROBES
K031371 · GEI
Smith & Nephew, Inc.
General & Plastic Surgery · 23d
Cleared May 23, 2003
MODIFICATION TO TRUPEAK PEAK FLOW METER
K031514 · BZH
Monaghan Medical Corp.
Anesthesiology · 9d
Cleared May 22, 2003
AVITA BF1 (VITALIO) BODY FAT ANALYZER
K020738 · MNW
Avita Corporation
Gastroenterology & Urology · 442d
Cleared May 22, 2003
HLS UNI EVOLUTION PROSTHESIS
K022211 · HSX
Tornier
Orthopedic · 318d
Cleared May 22, 2003
CODMAN ISOCOOL BIPOLAR FORCEPS
K023566 · GEI
Codman & Shurtleff, Inc.
General & Plastic Surgery · 211d
Cleared May 22, 2003
EASYCUP
K023823 · JHI
Zer Hitech
Chemistry · 188d
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