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
60457–60480 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 02, 2007
TUTTNAUER PREVACUUM STEAM HEATED AUTOCLAVE, MODELS 6990 SP-1A, 66120 SP-1A,...
K063711 · FLE
Tuttnauer Co. , Ltd.
General Hospital · 50d
Cleared Feb 02, 2007
PCA ALUMINA FEMORAL HEADS
K063816 · LZO
Stryker Orthopaedics
Orthopedic · 42d
Cleared Feb 02, 2007
MASTER CLASSIC 5K LOW SPEED HANDPIECE, 20K LOW SPEED HANDPIECE, TM5 LOW SPEED...
K070001 · EFB
Mti Precision Products
Dental · 30d
Cleared Feb 02, 2007
STRYKER T4 HYTREL TOGA
K070078 · FYA
Stryker Instruments, Instruments Div.
General Hospital · 24d
Cleared Feb 01, 2007
SURGIMESH WN
K061445 · FTL
Aspide Medical
General & Plastic Surgery · 253d
Cleared Feb 01, 2007
VORTEX CT PORT ACCESS SYSTEM AND LIFEGUARD SAFETY INFUSION SET
K062414 · LJT
Rita Medical Systems, Inc.
General Hospital · 168d
Cleared Feb 01, 2007
HERPESELECT 1 AND 2 PLEXUS IGG, MODEL MP0900G
K062543 · MXJ
Focus Diagnostics, Inc.
Microbiology · 155d
Cleared Feb 01, 2007
FINOMETER MODEL-2 WITH ACCESSORIES
K063111 · DXN
Finapres Medical Systems B.V.
Cardiovascular · 113d
Cleared Feb 01, 2007
GLOBAL AP POROUS COATED HUMERAL STEM
K063652 · MBF
DePuy Orthopaedics, Inc.
Orthopedic · 55d
Cleared Feb 01, 2007
THERMOMED 1.8
K063748 · GEI
Thermosurgery Technologies, Inc.
General & Plastic Surgery · 44d
Cleared Feb 01, 2007
LIBERTY NORMAL GLUCOSE CONTROL SOLUTION, MODEL 2120045/ HIGH GLUCOSE CONTROL...
K063855 · JJX
Liberty Healthcare Group, Inc.
Chemistry · 35d
Cleared Feb 01, 2007
C.T.M. MOBILITY SCOOTER, MODEL HS-310
K070025 · INI
C.T.M. Homecare Product, Inc.
Physical Medicine · 29d
Cleared Feb 01, 2007
INHIBIN A CALIBRATORS & CONTROLS ON THE ACCESS IMMUNOASSAY SYSTEMS
K070144 · JIT
Beckman Coulter, Inc.
Chemistry · 16d
Cleared Feb 01, 2007
OMNIGUIDE BEAM PATH CO2 MARK III WAVEGUIDE FIBER
K070157 · GEX
Omniguide, Inc.
General & Plastic Surgery · 15d
Cleared Jan 31, 2007
ASTRA 300
K061571 · BZG
Sdi Diagnostics, Inc.
Anesthesiology · 239d
Cleared Jan 31, 2007
COSMELIGHT
K061720 · GEX
Penntack Enterprises, Inc.
General & Plastic Surgery · 226d
Cleared Jan 31, 2007
SOLARIS COMPATIBLE REUSABLE ADULT SPO2 FINGER SENSORS, MODELS S100A-090103...
K061931 · DQA
Solaris Medical Technology, Inc.
Anesthesiology · 208d
Cleared Jan 31, 2007
CERULOPLASMIN, MODEL 2055953
K062114 · CHN
Roche Diagnostics Corp.
Immunology · 191d
Cleared Jan 31, 2007
FRAXEL II SR LASER SYSTEM
K062303 · GEX
Reliant Technologies, Inc.
General & Plastic Surgery · 176d
Cleared Jan 31, 2007
WAKO LBA DCP TEST SYSTEM, MODEL 993-05301
K062368 · OAU
Wako Chemicals USA, Inc.
Immunology · 170d
Cleared Jan 31, 2007
COBAS INTEGRA CERULOPLASMIN
K062379 · JJY
Roche Diagnostics Corp.
Chemistry · 169d
Cleared Jan 31, 2007
REPROCESSED TROCARS
K062497 · NLM
Ascent Healthcare Solutions
Gastroenterology & Urology · 159d
Cleared Jan 31, 2007
AERO TRACHEOBRONCHIAL STENT SYSTEM, MODEL 90129-2XX
K062511 · JCT
Alveolus, Inc.
General & Plastic Surgery · 156d
Cleared Jan 31, 2007
RAPIDTEG TEG-ACT TEST
K062604 · JBP
Haemoscope Corp.
Hematology · 152d