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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
38881–38904 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 26, 2014
U&U HYDROGEN PEROXIDE GAS PLASMA STERILIZATION POUCH/ROLL
K123162 · FRG
U&U Medical Technology Co, Ltd.
General Hospital · 505d
Cleared Feb 26, 2014
TRINIAS
K123508 · OWB
Shimadzu Corporation
Radiology · 470d
Cleared Feb 26, 2014
STATUS DS OXY
K130650 · DJG
Princeton BioMeditech Corp.
Toxicology · 352d
Cleared Feb 26, 2014
ANAL RECTAL OVERTUBE
K131598 · FED
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 268d
Cleared Feb 26, 2014
EXCELERON BACTERIAL FILTERS
K131626 · CAH
Exceleron Medical
General Hospital · 267d
Cleared Feb 26, 2014
PRESSURE CONNECTING TUBE
K131770 · DQO
Shenzhen Ant Hi-Tech Industrial Co.,...
Cardiovascular · 254d
Cleared Feb 26, 2014
IFA 40: HEP-20-10
K131791 · DHN
Euroimmun US
Immunology · 253d
Cleared Feb 26, 2014
ARTHROSURFACE TOEMOTION
K132496 · LZJ
Arthrosurface, Inc.
Orthopedic · 201d
Cleared Feb 26, 2014
FLETCHER CT/MR SHIELDED APPLICATOR SET (6 MM) FLETCHER CT/MR SHIELDED...
K132889 · JAQ
Nucletron B.V.
Radiology · 163d
Cleared Feb 26, 2014
OSI Q SYSTEM ARTHROSCOPES
K133018 · HRX
Orthopedic Sciences, Inc.
Orthopedic · 154d
Cleared Feb 26, 2014
LUNGPOINT ATV PLANNING AND NAVIGATION SOFTWARE
K133385 · LLZ
Broncus Medical, Inc.
Radiology · 113d
Cleared Feb 26, 2014
NEMUS 2 SYSTEM
K133517 · GWL
Eb Neuro S.P.A.
Neurology · 103d
Cleared Feb 26, 2014
EMERGE MEDICAL BONE PLATE SYSTEM
K133536 · HRS
Emerge Medical
Orthopedic · 100d
Cleared Feb 26, 2014
SUREFIRE GUIDING CATHETER
K140034 · DQY
Surefire Medical, Inc.
Cardiovascular · 50d
Cleared Feb 26, 2014
EZONO 4000
K140254 · IYN
Ezono AG
Radiology · 26d
Cleared Feb 26, 2014
ST SENSE NV 8 ARRAY COIL
K140282 · MOS
Resonance Innovations, LLC
Radiology · 22d
Cleared Feb 25, 2014
EZ TRANSPORT CHAIR
K130517 · IOR
Harris Medical, LLC
Physical Medicine · 363d
Cleared Feb 25, 2014
RETRACTION PASTE
K130580 · MVL
Dmg USA, Inc.
Dental · 357d
Cleared Feb 25, 2014
SE-601 SERIES ELECTROCARDIOGRAPH
K131503 · DPS
Edan Instruments, Inc.
Cardiovascular · 277d
Cleared Feb 25, 2014
E-Z CHECK OZONE TEST STRIPS
K132344 · MSY
Reprocessing Products Corporation (Rpc)
Gastroenterology & Urology · 211d
Cleared Feb 25, 2014
CELLVIZIO 100 SERIES SYSTEM AND CELLVIZIO SYSTEM WITH CONFOCAL MINIPROBES
K132389 · OWN
Daniel & Daniel Consulting
General & Plastic Surgery · 208d
Cleared Feb 25, 2014
SMILEBOND SYSTEM
K132599 · ELW
Millennium Company, LLC
Dental · 189d
Cleared Feb 25, 2014
UP600 DIAGNOSTIC DOPPLER ULTRASOUND SYSTEM
K132690 · IYN
Qisda Corporation
Radiology · 181d
Cleared Feb 25, 2014
SFI-BAR IMPLANT ABUTMENTS
K132814 · NHA
Sterngold Dental, LLC
Dental · 169d