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

DYB 2016-06-03

Halo One Thin-Walled Guiding Sheath

Applicant C.R. Bard, Inc.

K-Number K161183

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LZO 2016-06-03

Corin Optimized Positioning System (OPS)

Applicant Corin USA

K-Number K152893

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HWC 2016-06-03

dynaMX(TM) Nitinol Compression Screw

Applicant Mx Orthopedics, Corp.

K-Number K160427

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BZH 2016-06-03

Wing Smart FEVI and Peak Flow Meter

Applicant Sparo, Inc.

K-Number K152276

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PNB 2016-06-03

WallFlex Biliary RX Fully Covered Stent System RMV

Applicant Boston Scientific

K-Number DEN150040

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OMA 2016-06-03

Background Pattern Classification [BPc(TM)]

Applicant Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)

K-Number K152301

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CBP 2016-06-03

Seal Rite Non-Rebreathing Valve

Applicant The Lifeguard Store, Inc.

K-Number K152521

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IKT 2016-06-03

Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes

Applicant Bio Protech, Inc.

K-Number K152984

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GEI 2016-06-02

ABC D-FLEX PROBE

Applicant Conmed Corporation

K-Number K151229

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DZE 2016-06-02

Anker II Dental Implant System

Applicant Alliance Global Technology Co., Ltd.

K-Number K152576

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DZE 2016-06-02

NobelSpeedy Groovy

Applicant Nobel Biocare AB

K-Number K160119

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EIH 2016-06-02

CEREC SpeedGlaze

Applicant Sirona Dental Systems GmbH

K-Number K160099

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