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

DYB 2018-03-30

Performer Guiding Sheath

Applicant Cook Incorporated

K-Number K171988

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LNH 2018-03-30

G-scan Brio

Applicant Esaote, S.p.A.

K-Number K180592

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NHA 2018-03-30

Straumann Variobase for Crown AS

Applicant Institut Straumann AG

K-Number K173379

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MSB 2018-03-30

SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System

Applicant Paragonix Technologies, Inc.

K-Number K180194

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FGB 2018-03-30

OLYMPUS URF-V2/V2R

Applicant Olympus Medical Systems Corp.

K-Number K172246

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DQY 2018-03-30

Merit Pursue Microcatheter

Applicant Merit Medical Systems, Inc.

K-Number K173548

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DZE 2018-03-30

UF(II) Implant System

Applicant Dio Corporation

K-Number K170608

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PKR 2018-03-30

gammaCore Sapphire

Applicant Electrocore, LLC

K-Number K180538

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JAK 2018-03-30

syngo.CT Coronary Analysis; syngo.CT Vascular Analysis

Applicant Siemens Medical Solutions USA, Inc.

K-Number K173637

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DQX 2018-03-30

Mandril Wire Guide

Applicant Cook Incorporated

K-Number K171997

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KWS 2018-03-29

Arthrex Shoulder System

Applicant Arthrex, Inc.

K-Number K171841

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OVD 2018-03-29

Arco™-SA Lumbar Cage System

Applicant Neurostructures, Inc.

K-Number K173082

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