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

PGW 2016-03-23

PointerShell Universal, PointerShell LS

Applicant Fiagon GmbH

K-Number K160479

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PCH 2016-03-22

Great Basin Shiga Toxin Direct Test

Applicant Great Basin Scientific, Inc.

K-Number K152955

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FCG 2016-03-22

Single Use Aspiration Needle NA-U401SX

Applicant Olympus Medical Systems Corp.

K-Number K160098

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LQD 2016-03-22

QbCheck

Applicant Qbtech AB

K-Number K143468

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GEH 2016-03-22

cryoFORM cryoICE cryoablation probe

Applicant AtriCure, Inc.

K-Number K152337

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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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