Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

OAP 2016-02-04

DermaScalp Laser Cap

Applicant Dermascalp, LLC

K-Number K152587

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LQY 2016-02-04

Dr's Finder

Applicant Good Doctors Co., Ltd.

K-Number K151274

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GEX 2016-02-04

NaturaLase CO2 Laser System

Applicant Focus Medical, LLC

K-Number K152529

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MAX 2016-02-04

Rampart A Lumbar Interbody Fusion Device

Applicant Spineology, Inc.

K-Number K153082

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OAS 2016-02-04

ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-Ray

Applicant Panoramic Corp.

K-Number K152489

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DXZ 2016-02-04

CorMatrix Tyke

Applicant Cormatrix Cardiovascular, Inc.

K-Number K152127

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IYE 2016-02-03

Adaptivo

Applicant Aurora Technology Development, LLC

K-Number K152994

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OLO 2016-02-03

Navigation Instruments

Applicant Globus Medical, Inc.

K-Number K153203

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IOR 2016-02-03

SUNTEC Mechanical Wheelchair, model ST-WL-1000

Applicant Danyang Suntec Auto Parts Co., Ltd.

K-Number K152878

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JDC 2016-02-03

Comprehensive SRS/Nexel Elbow

Applicant Biomet Manufacturing Corp

K-Number K153398

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EFB 2016-02-03

AIR-FLOW handy 3.0 PLUS

Applicant E.M.S Electro Medical Systems S.A

K-Number K151912

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LLZ 2016-02-03

Synapse PACS

Applicant Fujifilm Medical Systems U.S.A, Inc.

K-Number K160108

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