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
35305–35328 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 16, 2015
SOMATOM Definition Flash (VA48)
K143416 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 139d
Cleared Apr 16, 2015
BIS STANDARD SENSOR,1-CHANNEL (3 ELECTRODES)
K143506 · GXY
Covidien
Neurology · 127d
Cleared Apr 16, 2015
Voyant Fine Fusion Device
K143536 · GEI
Applied Medical Resources
General & Plastic Surgery · 122d
Cleared Apr 16, 2015
GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRAC
K143592 · NVQ
The Surgeon General, Department of...
Microbiology · 119d
Cleared CT Apr 16, 2015
PicoWay Laser System
K150326 · GEX
Candela Corporation
General & Plastic Surgery · 66d
Cleared Apr 16, 2015
Integra (R) Jarit (R) Kerrison Rongeurs, Integra (R) Ruggles (TM)-Redmons...
K150428 · HAE
Integra Lifesciences Corp.
Neurology · 56d
Cleared Apr 16, 2015
FlexPointer 1.5 mm
K150473 · PGW
Fiagon GmbH
Ear, Nose, Throat · 52d
Cleared Apr 16, 2015
Alcyone MEMS Cannula (AMC) System
K150660 · HCD
Alcyone Lifesciences, Inc.
Neurology · 34d
Cleared Apr 16, 2015
Nitroglycerin Sets with DUO-VENT Spike
K150860 · FPA
Baxter Healthcare Corporation
General Hospital · 15d
Cleared Apr 15, 2015
RUSCH ENDOBRONCHIAL TUBES
K141888 · CBI
Teleflexmedical, Inc.
Anesthesiology · 275d
Cleared Apr 15, 2015
PRODIGY AUTOCODE EJECT BLOOD GLUCOSE MONITORING SYSTEM
K141914 · NBW
Ok Biotech Co., Ltd.
Chemistry · 274d
Cleared Apr 15, 2015
InterActive Complete Surgical Tray
K142519 · KCT
Implant Direct Sybron Manufacturing, LLC
General Hospital · 219d
Cleared Apr 15, 2015
Dorsal Appliance
K143591 · LRK
Gergens Orthodontic Lab
Dental · 118d
Cleared Apr 15, 2015
EZvue UV, Soft Daily Wear Contact Lenses (ocufilcon D), EZvue Colors, Soft...
K150293 · LPL
I-See Vision Technology, Inc.
Ophthalmic · 68d
Cleared Apr 14, 2015
LC CALCIUMHYDROXIDE LINER
K141047 · EJK
S&C Polymer Silicon- Und Composite...
Dental · 356d
Cleared Apr 14, 2015
HONGYU DISPOSABLE SURGICAL DRAPES
K141324 · KKX
Weihai Hongyu Nonwoven Fabric...
General Hospital · 329d
Cleared Apr 14, 2015
LX-100 Hair Growth Stimulation System
K142824 · OAP
Hairlabs International, Inc.
General & Plastic Surgery · 196d
Cleared Apr 14, 2015
Acrylic Block
K143265 · EBI
Sun Medical Co., Ltd.
Dental · 152d
Cleared Apr 14, 2015
Delivery Analysis
K143269 · MUJ
Accuray Incorporated
Radiology · 152d
Cleared Apr 14, 2015
Fast Sphyg by Koven
K143332 · DXQ
Koven Technology, Inc.
Cardiovascular · 145d
Cleared Apr 14, 2015
Revital-Ox RESERT Solution Test Strip
K143333 · JOJ
STERIS Corporation
General Hospital · 145d
Cleared Apr 14, 2015
HeartSee
K143664 · KPS
University of Texas Medical School AT...
Radiology · 112d
Cleared Apr 14, 2015
IMPLANET Spine System (ISS)
K143731 · NKB
Implanet, S.A.
Orthopedic · 106d
Cleared Apr 14, 2015
MicroCross Catheter
K143744 · DQY
Roxwood Medical, Inc.
Cardiovascular · 104d