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
40177–40200 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 26, 2013
AIRO CT SYSTEM
K131431 · JAK
Mobius Imaging, LLC
Radiology · 132d
Cleared Sep 26, 2013
NANOR AND EFFICAST/NANOR HYBRID THERMOPLASTIC MATERIALS
K131795 · IYE
Orfit Industries NV
Radiology · 100d
Cleared Sep 26, 2013
SENOGRAPHE ESSENTIAL, PREMIUM VIEW I (PVI)
K131885 · MUE
GE Medical Systems SCS
Radiology · 93d
Cleared Sep 26, 2013
PHILIPS DXL 12/16-LEAD ECG ALGORITHM
K132068 · DPS
Philips Medical Systems
Cardiovascular · 85d
Cleared Sep 26, 2013
PROTURA COUCH SOFTWARE
K132084 · JAI
Med-Tec, Inc. D/B/A Civco Medical...
Radiology · 83d
Cleared Sep 26, 2013
ESTEYA
K132092 · JAD
Nucletron B.V.
Radiology · 83d
Cleared Sep 26, 2013
CG+ ARROW JACC POWERED BY ARROW VPS STYLET
K132133 · OBJ
Arrow International (Subsidiary of...
Cardiovascular · 77d
Cleared Sep 26, 2013
COCHLEAR BAHA 4 SOUND PROCESSOR
K132278 · LXB
Cochlear Americas
Ear, Nose, Throat · 65d
Cleared Sep 26, 2013
ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEM
K132654 · IYO
Siemens Medical Solutions USA, Inc....
Radiology · 31d
Cleared Sep 26, 2013
PERIMETER INTERBODY FUSION DEVICE
K132700 · MAX
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d
Cleared Sep 26, 2013
PRIMI SUPPORT CATHETER
K132701 · DQY
Thermopeutix, Inc.
Cardiovascular · 28d
Cleared Sep 26, 2013
NANOCROSS ELITE .14 OVER-THE-WIRE PTA, BALLOON DILATION CATHETER
K132777 · LIT
Ev3, Inc.
Cardiovascular · 21d
Cleared Sep 25, 2013
ACCESS ACCUTNI REAGENT, ACCESS ACCUTNI CALIBRATOR, UNICEL DXI 800 ACCESS...
K121790 · MMI
Beckman Coulter, Inc.
Chemistry · 464d
Cleared Sep 25, 2013
430 SWL 45 AND 430 SW 45 HIGH-SPEED HANDPIECES
K130455 · EFB
Dentalez Group, Stardental Division
Dental · 215d
Cleared Sep 25, 2013
ARTHREX COMPRESSION PLATES
K130510 · HRS
Arthrex, Inc.
Orthopedic · 210d
Cleared Sep 25, 2013
I-GEN
K131289 · JEY
Megagen Implant Co., Ltd.
Dental · 142d
Cleared Sep 25, 2013
POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE
K131440 · LZA
Hebei Hongsen Plastics Technology Co,...
General Hospital · 128d
Cleared Sep 25, 2013
FINESSIS VIOLET ELEMENT POLYISOPRENE POWDERFREE STERILE SURGICAL GLOVES
K131751 · KGO
Lucenxia Prescience AG
General Hospital · 103d
Cleared Sep 25, 2013
NDOHD HIGH DEFINITION IMAGING SYSTEM (NDOHD)
K131873 · LLZ
MethodSense, Inc.
Radiology · 93d
Cleared Sep 25, 2013
ECLIPSE TREATMENT PLANNING SYSTEM
K131891 · MUJ
Varian Medical Systems, Inc.
Radiology · 92d
Cleared Sep 25, 2013
XVI R5.0
K131965 · IYE
Elekta Limited
Radiology · 90d
Cleared Sep 25, 2013
MULTICHEM P
K131992 · JJY
Techno-Path Manufacturing , Ltd.
Immunology · 89d
Cleared Sep 25, 2013
JAZZ SYSTEM
K132287 · OWI
Hogan Lovells US LLP
Orthopedic · 64d
Cleared Sep 25, 2013
PELLEVE GLIDESAFE 10MM, 15MM & 20MM HANDPIECE, PELLEVE S5 - IEC
K132665 · GEI
Ellman International, Inc.
General & Plastic Surgery · 29d