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

FPA 2016-12-06

Q2 Multiport IV Administration Sets and Extension Sets, Checkmate Multiport IV Administration Sets, Q2 Extension Sets

Applicant Quest Medical, Inc.

K-Number K162304

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NEY 2016-12-06

Emprint Ablation System

Applicant Covidien, LLC

K-Number K163105

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DQX 2016-12-06

Endura guidewire

Applicant Vascular Solutions, Inc.

K-Number K161702

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FRO 2016-12-06

Talymed Suspension

Applicant Marine Polymer Technologies, Inc.

K-Number K160695

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HAW 2016-12-06

CRW STEREOTACTIC SYSTEM

Applicant Integra LifeSciences Corporation

K-Number K160811

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DRF 2016-12-06

Reprocessed Supreme Diagnostic Electrophysiology Catheters

Applicant Innovative Health, LLC

K-Number K161769

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DTZ 2016-12-06

Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface

Applicant Medtronic, Inc.

K-Number K162896

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LHI 2016-12-06

OnSite-IV

Applicant Pharmc, LLC

K-Number K161800

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KOI 2016-12-05

EZstim*III Peripheral Nerve Stimulator/Nerve Locator

Applicant Halyard Health - Irvine

K-Number K162048

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IOR 2016-12-05

APEX Manual Wheelchair

Applicant Motion Composites

K-Number K161425

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LPH 2016-12-05

Bencox M Stem Lateralized & Bencox Mirabo Cup System

Applicant Corentec Co., Ltd.

K-Number K162127

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GDW 2016-12-05

Tri-Staple 2.0 Intelligent Cartridge

Applicant Covidien, LLC

K-Number K163098

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