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

MWJ 2016-06-13

NR Recorder

Applicant Norav Medical GmbH

K-Number K161062

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OZX 2016-06-13

illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10

Applicant Meridian Bioscience, Inc.

K-Number K160829

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MHX 2016-06-13

M3290B Philips IntelliVue Information Center iX

Applicant Philips Medical Systems

K-Number K153702

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DQX 2016-06-13

Arrow Quickflash Arterial Catheterization Device

Applicant Arrow International, Inc. (Subsidiary of Teleflex, Inc.)

K-Number K160018

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PNL 2016-06-13

Magnetic Surgical System

Applicant Levita Magnetics International Corp

K-Number DEN150007

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PMT 2016-06-13

Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5

Applicant Roche Diagnostics

K-Number K160729

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NRY 2016-06-12

Penumbra System ACE 68 Reperfusion Catheter

Applicant Penumbra, Inc.

K-Number K161064

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GXR 2016-06-12

Cranial COVER

Applicant Neos Surgery S.L

K-Number K160739

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OWW 2016-06-10

VersaWrap Tendon Protector

Applicant Alafair Biosciences, Inc.

K-Number K160364

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NLH 2016-06-10

Reprocessed Inquiry Steerable Diagnostic EP Catheter

Applicant Innovative Health, LLC

K-Number K160496

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HRS 2016-06-10

NEOVIEW Plating System

Applicant In2bones Sas

K-Number K160995

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PDQ 2016-06-10

DSG Threaded Drill System

Applicant Spineguard S.A.

K-Number K152747

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