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

DYG 2016-05-03

Swan Ganz Catheters

Applicant Edwards Lifesciences, LLC

K-Number K160084

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GEI 2016-05-03

SERFAS 90-S Electrosurgical Probe

Applicant Stryker Corporation

K-Number K160050

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MBI 2016-05-03

STROPP (Single Tunnel Repair of Plantar Plate)

Applicant Crossroads Extremity Systems, LLC

K-Number K160118

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MXZ 2016-05-03

FLEX Monoclonal Rabbitt Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (Link); FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, Ready-to-Use (Link)

Applicant Dako North America, Inc.

K-Number K160922

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HQF 2016-05-02

Green Laser Photocoagulator GYC-500

Applicant Nidek Co., Ltd.

K-Number K152603

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GDJ 2016-05-02

Standard Clamp

Applicant Standard Bariatrics

K-Number K153358

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BZD 2016-05-02

AirFit N20

Applicant Resmed, Ltd.

K-Number K153673

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IYN 2016-05-02

TRINITY

Applicant Koelis

K-Number K160357

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PGY 2016-05-02

MX50T(MX50TQS)

Applicant Wide Corporation

K-Number K160354

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DZE 2016-05-02

BTI Dental Implant System UnicCa

Applicant B.T.I. Biotechnology Institute, Sl.

K-Number K151391

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LPL 2016-05-02

AIR OPTIX plus HydraGlyde, AIR OPTIX plus HydraGlyde for Astigmatism, AIR OPTIX plus HydraGlyde Multifocal, AIR OPTIX plus HydraGlyde Multifocal Toric

Applicant Alcon Laboratories, Inc.

K-Number K160609

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LZC 2016-05-02

Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs

Applicant Maxter Glove Manufacturing Sdn Bhd

K-Number K151390

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