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
32833–32856 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 16, 2016
Caspian OCT/MESA Mini/DENALI Mini Spinal System
K153370 · NKG
K2m, Incorporated
Orthopedic · 85d
Cleared Feb 16, 2016
NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon,...
K153479 · NQQ
Ninepoint Medical, Inc.
General & Plastic Surgery · 76d
Cleared Feb 16, 2016
FUSION Vascular Graft
K153523 · DSY
Maquet Cardiovascular, LLC
Cardiovascular · 69d
Cleared Feb 16, 2016
Zimmer Virage OCT Spinal Fixation System
K153631 · NKG
Zimmer Spine, Inc.
Orthopedic · 60d
Cleared Feb 16, 2016
TSolution One w/ACG+ Surgical System
K153647 · OLO
THINK Surgical, Inc.
Orthopedic · 57d
Cleared Feb 15, 2016
Intact® Gen2 System
K152596 · KNW
Intact Medical Corporation
Gastroenterology & Urology · 158d
Cleared Feb 15, 2016
Clear Bi-Light
K153081 · OLP
Michael Todd, LP
General & Plastic Surgery · 115d
Cleared Feb 14, 2016
Star 60
K151512 · MWI
Skanray Technologies Private Limited
Cardiovascular · 255d
Cleared Feb 12, 2016
Pain Therapy System, Model PTS-II
K150277 · NUH
Counter Scientific Development (Gz),...
Neurology · 372d
Cleared Feb 12, 2016
X-Suit NIR Biliary Metallic Stent
K150487 · FGE
Medinol, Ltd.
Gastroenterology & Urology · 352d
Cleared Feb 12, 2016
ProTrach Dualcare
K151404 · JOH
Atos Medical AB
Anesthesiology · 262d
Cleared Feb 12, 2016
QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1...
K151429 · LLL
Inova Diagnostics, Inc.
Immunology · 260d
Cleared Feb 12, 2016
Tranberg CLS Laser Fiber
K151569 · GEX
Clinical Laserthermia Systems, AB
General & Plastic Surgery · 247d
Cleared Feb 12, 2016
Masimo Root Vital Signs Monitoring System and Accessories
K151644 · MWI
Masimo Corporation
Cardiovascular · 239d
Cleared Feb 12, 2016
Powder Free Nitrile Patient Examination Gloves, Blue Color
K151680 · LZA
Suqian Xingye Glove Co,Ltd
General Hospital · 235d
Cleared Feb 12, 2016
MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws,...
K152187 · HWC
Merete Medical GmbH
Orthopedic · 191d
Cleared Feb 12, 2016
Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 Guidewire
K152231 · DQX
Boston Scientific Corporation
Cardiovascular · 189d
Cleared Feb 12, 2016
Adena-Zina System
K152781 · NKB
Shanghai Sanyou Medical Co, Ltd.
Orthopedic · 140d
Cleared Feb 12, 2016
Clear Guide SCENERGY
K153004 · JAK
Clear Guide Medical
Radiology · 122d
Cleared Feb 12, 2016
Microlife Upper Arm Automatic Digital Blood Pressure Monitor
K153077 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 112d
Cleared Feb 12, 2016
CARESTREAM Vue PACS
K153103 · LLZ
Carestream Health, Inc.
Radiology · 109d
Cleared Feb 12, 2016
Arthrex Synergy UHD4 System
K153218 · GCJ
Arthrex, Inc.
General & Plastic Surgery · 99d
Cleared Feb 12, 2016
PTFE Super Sheath Introducer 2.1
K153246 · DYB
Medcomp (Medical Components, Inc.)
Cardiovascular · 95d
Cleared Feb 12, 2016
HS SutureTape
K153307 · GAT
Riverpoint Medical
General & Plastic Surgery · 88d