Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) 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

NHA 2016-09-15

Dentium Implantium & SuperLine Prosthetics

Applicant Dentium Co., Ltd.

K-Number K160828

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LEJ 2016-09-15

KBL Sunlamp Products (= Device Bundling name)

Applicant Kbl AG

K-Number K151962

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GEI 2016-09-15

PhotonBlade

Applicant Invuity, Inc.

K-Number K162053

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NCX 2016-09-15

TEMPEDY

Applicant Seiratherm GmbH

K-Number K152946

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GEI 2016-09-15

LigaSure Impact Curved, Large Jaw, Open Sealer/Divider, Nano-coated

Applicant Covidien

K-Number K162047

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GAW 2016-09-15

Pledgeted COR-SUTURE QUICK LOAD

Applicant Lsi Soultions

K-Number K160529

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QSZ 2016-09-15

Mirragen Advanced Wound Matrix, 4x4, Mirragen Advanced Wound Matrix, 2x2, Mirragen Advanced Wound Matrix, 1x6

Applicant Engineered Tissue Solutions, LLC

K-Number K161067

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NUH 2016-09-15

HBOTC Muscle and Nerve Stimulator

Applicant Hb Medical, Inc.

K-Number K160255

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GEH 2016-09-15

Compound W Wart Removal System Dual Power

Applicant Medtech Products, Inc.

K-Number K161294

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CGA 2016-09-14

GEM Premier 3000

Applicant Instrumentation Laboratory CO

K-Number K161818

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PPS 2016-09-14

Flexitouch System

Applicant Tactile Systems Technology, Inc. (Dba Tactile Medical)

K-Number K153311

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NHA 2016-09-14

CAM Titanium Blanks

Applicant Altatec GmbH

K-Number K160784

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