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

MEH 2016-03-31

Corin TriFit TS Hip

Applicant Corin U.S.A. Limited

K-Number K153772

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HAW 2016-03-30

BrightMatter Guide with Surface Trace Registration

Applicant Synaptive Medical, Inc.

K-Number K153281

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NAY 2016-03-30

da Vinci Surgical System, Model IS4000

Applicant Intuitive Surgical, Inc.

K-Number K152578

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ILY 2016-03-30

Elysiom Polychromatic LED Light Therapy (PLLT) System (Elysiom)

Applicant In Light Wellness Systems, Inc.

K-Number K153389

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MHX 2016-03-30

AVIVO Mobile Patient Management (MPM) System

Applicant Medtronic, Inc.

K-Number K153160

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FDI 2016-03-30

Rotatable Snares

Applicant Boston Scientific Corporation

K-Number K160637

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CBK 2016-03-30

Flight 60 Ventilator

Applicant Flight Medical Innovations , Ltd.

K-Number K143035

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KPR 2016-03-30

Visaris Vision® (Vision C, Vision U. Vision V, Vision X)

Applicant Visaris D.O.O. Belgrade

K-Number K160620

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LLZ 2016-03-29

Synaptive ImageDrive Pro

Applicant Synaptive Medical, Inc.

K-Number K153284

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DXN 2016-03-29

Full Automatic (NIBP) Blood Pressure Monitor

Applicant Health & Life Co., Ltd.

K-Number K160336

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GEX 2016-03-29

PURE CRYOGEN

Applicant Air Liquide Healthcare America Corporation

K-Number K153564

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EIH 2016-03-29

X-cera Zirconia Blanks

Applicant Shenzhen Xiangtong Photoelectricity Technology Co., Ltd.

K-Number K153767

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