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
32905–32928 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 05, 2016
N5-1
K153054 · JFB
Nuga Medical Co., Ltd.
Physical Medicine · 108d
Cleared Feb 05, 2016
MOR Implant System
K153173 · DZE
Sterngold Dental, LLC
Dental · 94d
Cleared Feb 05, 2016
Cryocare CS Surgical System
K153489 · GEH
Healthtronics
General & Plastic Surgery · 63d
Cleared Feb 05, 2016
Stryker CMF MEDPOR Customized Implant
K153508 · FWP
Stryker
General & Plastic Surgery · 60d
Cleared Feb 05, 2016
Bridge Occlusion Balloon
K153530 · MJN
Spectranetics, Inc.
Cardiovascular · 58d
Cleared Feb 04, 2016
Dr's Finder
K151274 · LQY
Good Doctors Co., Ltd.
Dental · 267d
Cleared Feb 04, 2016
CorMatrix Tyke
K152127 · DXZ
Cormatrix Cardiovascular, Inc.
Cardiovascular · 188d
Cleared Feb 04, 2016
The Entasis Dual-Lead Sacroiliac Implant
K152237 · OUR
Corelink, LLC
Orthopedic · 178d
Cleared Feb 04, 2016
ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-Ray
K152489 · OAS
Panoramic Corp.
Radiology · 156d
Cleared Feb 04, 2016
NaturaLase CO2 Laser System
K152529 · GEX
Focus Medical, LLC
General & Plastic Surgery · 154d
Cleared Feb 04, 2016
DermaScalp Laser Cap
K152587 · OAP
Dermascalp, LLC
General & Plastic Surgery · 147d
Cleared Feb 04, 2016
Medline Anti-Fog Solution
K152948 · OCT
Medline Industries, Inc.
Gastroenterology & Urology · 121d
Cleared Feb 04, 2016
Rampart A Lumbar Interbody Fusion Device
K153082 · MAX
Spineology, Inc.
Orthopedic · 104d
Cleared CT Feb 04, 2016
DyeVert Contrast Modulation System
K153141 · DXT
Osprey Medical, Inc.
Cardiovascular · 97d
Cleared Feb 04, 2016
CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS
K153487 · LJS
Arrow International, Inc. (Subsidiary...
General Hospital · 62d
Cleared Feb 03, 2016
AIR-FLOW handy 3.0 PLUS
K151912 · EFB
E.M.S Electro Medical Systems S.A
Dental · 205d
Cleared Feb 03, 2016
SUNTEC Mechanical Wheelchair, model ST-WL-1000
K152878 · IOR
Danyang Suntec Auto Parts Co., Ltd.
Physical Medicine · 126d
Cleared Feb 03, 2016
Adaptivo
K152994 · IYE
Aurora Technology Development, LLC
Radiology · 113d
Cleared Feb 03, 2016
Navigation Instruments
K153203 · OLO
Globus Medical, Inc.
Orthopedic · 91d
Cleared Feb 03, 2016
Comprehensive SRS/Nexel Elbow
K153398 · JDC
Biomet Manufacturing Corp
Orthopedic · 71d
Cleared Feb 03, 2016
Synapse PACS
K160108 · LLZ
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 15d
Cleared Feb 02, 2016
Top Fine Pen Needle
K152410 · FMI
Medexel Co.,Ltd
General Hospital · 160d
Cleared Feb 02, 2016
HF1202H PowerPlus Portable X-ray Equipment
K153059 · IZL
Minxray, Inc.
Radiology · 104d
Cleared Feb 02, 2016
M-Fix Acromioclavicular Device
K153211 · HTN
Coracoid Solutions, Inc.
Orthopedic · 89d