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

OLO 2017-03-02

Intellijoint HIP Generation 2A System

Applicant Intellijoint Surgical, Inc.

K-Number K162364

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FIP 2017-03-02

EndoPur Filter

Applicant Nephros, Inc.

K-Number K161304

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EIH 2017-03-02

n!ce Glass Ceramic Blocks for Amann Girrbach

Applicant Institut Straumann AG

K-Number K170420

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NUV 2017-03-02

Slimming Treatment Device

Applicant Beijing Honkon Technologies Co., Ltd.

K-Number K161892

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CAN 2017-03-02

MR Conditional CGA 870

Applicant Essex Industries, Inc.

K-Number K162811

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MUJ 2017-03-02

RayStation 6

Applicant RaySearch Laboratories AB (PUBL)

K-Number K170355

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GKZ 2017-03-02

Dextramer CMV Kit

Applicant Immudex Aps

K-Number K153538

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EOB 2017-03-02

TIPCAM 1S 3D System

Applicant Karl Storz Endoscopy America, Inc.

K-Number K162410

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IKT 2017-03-02

Myoject Luer Lock Needle Electrode

Applicant Natus Manufacturing Limited

K-Number K161430

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GAR 2017-03-02

REXLON, REXSIL

Applicant Sm Eng Co., Ltd.

K-Number K161633

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KWZ 2017-03-02

EXPRT™ Revision Hip System - EXPRT™ Hip Distal Stem, EXPRT™ Hip Standard Offset Proximal Body Implant, EXPRT™ Hip Lateral Offset Proximal Body Implant, EXPRT™ Hip Capture Bolt

Applicant Encore Medical L.P.

K-Number K163497

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GDW 2017-03-02

Signia Four-Bay Smart Charger (to be used with Signia Stapler)

Applicant Covidien

K-Number K170348

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