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
33097–33120 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 13, 2016
Penumbra System ACE 64 and ACE 68 Reperfusion Catheters
K152541 · NRY
Penumbra, Inc.
Neurology · 131d
Cleared Jan 13, 2016
IFS Fixation Scaffold System
K152627 · HTY
Metric Medical Devices, Inc.
Orthopedic · 120d
Cleared Jan 13, 2016
Nerve Capping Device
K152684 · JXI
Polyganics Innovations BV
Neurology · 117d
Cleared Jan 13, 2016
FFRct
K152733 · PJA
HeartFlow, Inc.
Cardiovascular · 113d
Cleared Jan 13, 2016
S50 Digital Color Doppler Ultrasound System
K152854 · IYN
Sonoscape Medical Corp.
Radiology · 106d
Cleared Jan 13, 2016
NuVasiveNVM5 System
K152942 · PDQ
Nu Vasive, Incorporated
Neurology · 100d
Cleared Jan 13, 2016
IntraNovo Microcatheter
K153125 · DQO
Texasmedical Technologies, Inc.
Cardiovascular · 76d
Cleared Jan 13, 2016
Frontier Medical Devices In-Line Orthopedic Cable Cerclage System
K153242 · JDQ
Frontier Medical Devices, Inc.
Orthopedic · 65d
Cleared Jan 13, 2016
Reprocessed Stryker External Fixation Devices
K153415 · KTT
Stryker Sustainability Solutions
Orthopedic · 49d
Cleared Jan 13, 2016
SALVATION(R) External Fixation System
K153635 · KTT
Wrightmedicaltechnologyinc
Orthopedic · 26d
Cleared Jan 12, 2016
IQSense Flow Sensor Mouthpiece
K150515 · BZG
Sdi Diagnostics, Inc.
Anesthesiology · 316d
Cleared Jan 12, 2016
ImplantMax Software
K151152 · LLZ
Saturn Imaging, Inc.
Radiology · 257d
Cleared Jan 12, 2016
core nova Complete Operating Room Endoscopy
K151282 · ODA
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 243d
Cleared Jan 12, 2016
Endoscope Sterilization Tray
K151450 · KCT
Intuitive Surgical, Inc.
General Hospital · 228d
Cleared Jan 12, 2016
CAMLOG and CONELOG Abutments for Screw-retained Restorations (ASR)
K152509 · NHA
Altatec GmbH
Dental · 132d
Cleared Jan 12, 2016
Bio2 CLM BG Bioactive Scaffold
K152589 · MQV
Bio2 Technologies, Inc.
Orthopedic · 124d
Cleared Jan 12, 2016
INFX-8000V, V6.20
K152696 · OWB
Toshibamedical Systems Corporation
Radiology · 113d
Cleared Jan 12, 2016
Biograph Horizon PET/CT
K152880 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 104d
Cleared Jan 12, 2016
MUSE Cardiology Information System
K152993 · DQK
Ge Medical Systems Information...
Cardiovascular · 91d
Cleared CT Jan 12, 2016
Sofia Influenza A+B FIA
K153012 · PSZ
Quidel Corporation
Microbiology · 90d
Cleared Jan 12, 2016
Cios Connect
K153147 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 74d
Cleared Jan 12, 2016
3MP Color LCD Monitor, RadiForce RX350
K153354 · PGY
Eizo Corporation
Radiology · 53d
Cleared Jan 11, 2016
Sysmex Automated Blood Coagulation Analyzer CS-5100
K150678 · JPA
Siemens Healthcare Diagnostic...
Hematology · 301d
Cleared Jan 11, 2016
Universa Soft Ureteral Stents and Stent Sets
K151051 · FAD
Cook Incorporated
Gastroenterology & Urology · 266d