FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

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

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175,820 results
11953–11976 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 19, 2023
Disposable Non-invasive EEG Sensor
K220448 · GXY
Shenzhen Med-Link Electronics Tech...
Neurology · 337d
Cleared Jan 19, 2023
Tunnel Crossing Catheter
K221163 · PDU
Tractus Vascular, LLC
Cardiovascular · 272d
Cleared Jan 19, 2023
HF-cables (resusable)
K221522 · GEI
Olympus Winter & Ibe GmbH
Gastroenterology & Urology · 238d
Cleared Jan 19, 2023
PerfusionGo Plus
K221627 · LLZ
Yukun (Beijing) Technology Co., Ltd.
Radiology · 227d
Cleared Jan 19, 2023
Self-adhesive Electrode
K222252 · GXY
Shenzhen Roundwhale Technology Co. ,...
Neurology · 176d
Cleared Jan 19, 2023
EL CAPITAN Anterior Lumbar Interbody Fusion
K222554 · OVD
Astura Medical
Orthopedic · 149d
Cleared Jan 19, 2023
TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN...
K223108 · OLO
Medos International SARL
Orthopedic · 111d
Cleared Jan 19, 2023
Medaica M1 Telehealth Stethoscope
K223166 · DQD
Medaica, Inc.
Cardiovascular · 104d
Cleared Jan 19, 2023
Disposable Nitrile Examination Glove
K223250 · LZA
Yangzhou Saraguard Medical Supplies...
General Hospital · 90d
Cleared Jan 19, 2023
Access 25(OH) Vitamin D Total
K223503 · MRG
Beckman Coulter, Inc.
Chemistry · 58d
Cleared Jan 19, 2023
AvalancheLase Family
K223540 · GEX
Fotona D.O.O.
General & Plastic Surgery · 55d
Cleared Jan 19, 2023
Low Profile Companion Sheath
K223872 · DYB
Merit Medical Systems, Inc.
Cardiovascular · 27d
Cleared Jan 18, 2023
Selux AST System
K211759 · LON
Selux Diagnostics, Inc.
Microbiology · 590d
Cleared Jan 18, 2023
MultiCut Solo
K213597 · GCJ
Asclepion Laser Technologies GmbH
Obstetrics & Gynecology · 432d
Cleared Jan 18, 2023
Anatomic Bone Plate
K221088 · HRS
Double Medical Technology, Inc.
Orthopedic · 280d
Cleared Jan 18, 2023
Uni-FuZe-C Bone Strip
K221726 · MQV
Zavation Medical Products, LLC
Orthopedic · 218d
Cleared Jan 18, 2023
Transit-Pellets
K222000 · FFX
Medifactia AB
Gastroenterology & Urology · 195d
Cleared Jan 18, 2023
TruPlan Computed Tomography (CT) Imaging Software
K222593 · LLZ
Circle Cardiovascular Imaging, Inc.
Radiology · 145d
Cleared Jan 18, 2023
MOLLI 2
K223107 · NEU
Molli Surgical, Inc.
General & Plastic Surgery · 110d
Cleared Jan 18, 2023
eXciteOSA without remote control (3000)
K223446 · QNO
Signifier Medical Technologies, Ltd.
Dental · 64d
Cleared Jan 18, 2023
PercuNav Image Fusion and Interventional Navigation System
K223804 · JAK
Philips Ultrasound, LLC
Radiology · 30d
Cleared Jan 18, 2023
SI-Cure Sacroiliac Joint Fusion System
K223819 · OUR
Alevio, LLC
Orthopedic · 28d
Cleared Jan 17, 2023
HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch)
K213655 · IPF
Hilltek, LLC
Physical Medicine · 424d
Cleared Jan 17, 2023
Elucis
K220649 · LLZ
Realize Medical, Inc.
Radiology · 316d