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
30889–30912 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 14, 2016
BracePaste Adhesive
K160782 · DYH
American Orthodontics
Dental · 206d
Cleared Oct 14, 2016
iNSitu Total Hip System
K161184 · LPH
Theken Companies, LLC
Orthopedic · 170d
Cleared Oct 14, 2016
HawkOne Directional Atherectomy System
K161361 · MCW
Medtronic Vascular, Inc.
Cardiovascular · 151d
Cleared Oct 14, 2016
R2P SlenGuide
K161546 · DQY
Ashitaka Factory of Terumo Corporation
Cardiovascular · 133d
Cleared Oct 14, 2016
Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws
K161569 · LPH
Howmedica Osteonics Corp. A.K.A....
Orthopedic · 129d
Cleared Oct 14, 2016
D-10 Hemoglobin A1c Program
K161687 · PDJ
Bio-Rad Laboratories, Inc.
Chemistry · 119d
Cleared Oct 14, 2016
Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug...
K161714 · DIS
Immunalysis Corporation
Toxicology · 115d
Cleared Oct 14, 2016
CUSA Clarity Ultrasonic Surgical Aspirator System
K161882 · LFL
Integra LifeSciences Corporation
General & Plastic Surgery · 95d
Cleared Oct 14, 2016
Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood Pressure...
K161886 · DXN
Guangdong Transtek Medical...
Cardiovascular · 95d
Cleared Oct 14, 2016
ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tip
K161912 · MOF
Asahi Intecc Co., Ltd.
Neurology · 94d
Cleared Oct 14, 2016
Olive Plus
K161981 · GEX
Ama Network, Inc.
General & Plastic Surgery · 87d
Cleared Oct 14, 2016
MedDream
K162011 · LLZ
Softneta Uab
Radiology · 85d
Cleared Oct 14, 2016
MyLabSix CrystaLine
K162290 · IYN
Esaote, S.P.A.
Radiology · 60d
Cleared Oct 14, 2016
BSD3543 Digital Flat Panel X-ray Detector
K162487 · MQB
Bontech, Inc.
Radiology · 37d
Cleared Oct 14, 2016
VascuCel
K162579 · DXZ
Admedus Regen Pty, Ltd.
Cardiovascular · 29d
Cleared Oct 13, 2016
Sunmed Haemostatic Valves
K153685 · DQX
Sunny Medical Device (Shenzhen) Co.,...
Cardiovascular · 296d
Cleared Oct 13, 2016
XCage™ Interbody Fusion System
K160076 · MAX
Ouroboros Medical, Inc.
Orthopedic · 273d
Cleared Oct 13, 2016
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for...
K160562 · LZA
Hartalega Snd. Bhd.
General Hospital · 227d
Cleared Oct 13, 2016
VT·One, VT·One 60days
K161410 · OMP
Carilex Medical, Inc.
General & Plastic Surgery · 146d
Cleared Oct 13, 2016
OTC TENS Device, Model PTS-IV
K161537 · NUH
Counter Scientific Development (Gz),...
Neurology · 132d
Cleared Oct 13, 2016
Overwatch Spine System
K161842 · NKB
Amendia, Inc.
Orthopedic · 100d
Cleared Oct 13, 2016
ADVIA Centaur HAV IgM Assay
K161964 · LOL
Siemens Healthcare Diagnostics, Inc.
Microbiology · 87d
Cleared Oct 13, 2016
Bioflux Software
K162571 · DSH
Biotricity, Inc.
Cardiovascular · 28d
Cleared Oct 13, 2016
AIR OPTIX COLORS
K162596 · LPL
Alcon Laboratories, Inc.
Ophthalmic · 27d