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

EBI 2016-03-22

ClearMet

Applicant Mycone Dental Supply Co., T/A Keystone Industries

K-Number K152051

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KWQ 2016-03-22

Z-Span Plate System

Applicant Zavation, LLC

K-Number K160362

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LNH 2016-03-22

Ingenia 1.5T and Ingenia 1.5T S R5.2

Applicant Philips Medical Systems Nederlands B.V.

K-Number K153324

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LYZ 2016-03-22

Glide-On Vinyl Examination Gloves

Applicant Medline Industries, Inc.

K-Number K151754

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GDW 2016-03-22

ECHELON FLEX 60 Powered Plus Compact Articulating Endoscopic Linear Cutter, 280mm

Applicant Ethicon Endo-Surgery, LLC

K-Number K160521

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LZA 2016-03-21

Powder Free Polychloroprene Examination Glove Green

Applicant Terang Nusa Sdn Bhd

K-Number K153510

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KCT 2016-03-21

Genesis Low Temperature Reusable Rigid Container System

Applicant Carefusion 2200, Inc.

K-Number K153554

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GXY 2016-03-21

Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup Electrodes

Applicant Bio Protech, Inc.

K-Number K153019

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KPS 2016-03-21

D-SPECT Processing and Reviewing Workstation

Applicant Spectrum Dynamics , Ltd.

K-Number K160120

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ONF 2016-03-21

Venus Versa System

Applicant Venus Concept , Ltd.

K-Number K153717

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IYO 2016-03-21

SpeqT

Applicant Signostics Limited

K-Number K160420

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JDR 2016-03-21

OS2(R)-VP Varisation Staple

Applicant In2bones Sas

K-Number K153770

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