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
32569–32592 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 17, 2016
ClearPoint System
K160434 · HAW
Mri Interventions, Inc.
Neurology · 30d
Cleared Mar 17, 2016
FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch
K160462 · PLO
Biofire Diagnostics, LLC
Microbiology · 27d
Cleared Mar 16, 2016
SPINAUT-V, SPINAUT-S, SPINAUT-I
K151268 · HRX
Imedicom Co., Ltd.
Orthopedic · 308d
Cleared Mar 16, 2016
SUSTAIN Additional Implants
K151665 · MAX
Globus Medical, Inc.
Orthopedic · 271d
Cleared Mar 16, 2016
NobelZygoma 45°
K152093 · DZE
Nobel Biocare AB
Dental · 232d
Cleared Mar 16, 2016
Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System
K153250 · OVE
Renovis Surgical Technologies
Orthopedic · 128d
Cleared Mar 16, 2016
Xeleris 4.0 Processing and Review Workstation
K153355 · LLZ
Ge Healthcare
Radiology · 117d
Cleared Mar 16, 2016
DReal
K153519 · HBE
Carevature Medical, Ltd.
Neurology · 99d
Cleared Mar 16, 2016
Cerafix Dura Substitute
K153613 · GXQ
Acera Surgical, Inc.
Neurology · 90d
Cleared Mar 16, 2016
Vitrea CT Colon Analysis
K160150 · LLZ
Vital Images, Inc.
Radiology · 55d
Cleared Mar 16, 2016
FUJIFILM FC1 Ultrasound System
K160406 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 29d
Cleared Mar 16, 2016
HemosIL Silica Clotting Time
K160445 · GFO
Instrumentation Laboratory CO
Hematology · 28d
Cleared Mar 15, 2016
MODEL 621/624 BIOMAGNETOMETER
K151135 · DPS
Tristan Technologies, Inc.
Cardiovascular · 321d
Cleared Mar 15, 2016
PerioLase Nd:YAG Pulsed Dental Laser System
K151763 · GEX
Millennium Dental Technologies, Inc.
General & Plastic Surgery · 260d
Cleared Mar 15, 2016
Dignity Dual Port
K153238 · LJT
Medcomp ( Medical Components)
General Hospital · 127d
Cleared Mar 15, 2016
AlertWatch: OR
K153335 · MWI
Alertwatch, LLC
Cardiovascular · 117d
Cleared Mar 15, 2016
NeoTract UroLift System UL500
K153584 · PEW
Neotract, Inc.
Gastroenterology & Urology · 91d
Cleared Mar 15, 2016
ArthrexVIP Web Portal
K153612 · LLZ
Custom Orthopaedic Solutions, Inc.
Radiology · 89d
Cleared Mar 15, 2016
Endoform Reconstructive Template
K153633 · FTM
Aroa Biosurgery Limited (Formerly...
General & Plastic Surgery · 88d
Cleared Mar 15, 2016
Xspan Laminoplasty Fixation System
K160114 · NQW
X-Spine Systems, Inc.
Orthopedic · 56d
Cleared Mar 15, 2016
AOS Anterolateral Proximal Humeral Plate
K160409 · KTW
Advanced Orthopaedic Solutions, Inc.
Orthopedic · 28d
Cleared Mar 15, 2016
FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch
K160457 · PEN
Biofire Diagnostics, LLC
Microbiology · 25d
Cleared Mar 14, 2016
UCP Stem
K152530 · LZO
United Orthopedic Corporation
Orthopedic · 193d
Cleared Mar 14, 2016
Allied Biocompat Abutment for Nobel Replace Interface
K152845 · NHA
Allied Dental Solutions
Dental · 167d