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

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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NUJ 2016-05-02

Medline ReNewal Reprocessed LigaSure Impact Open Sealer/Divider

Applicant Surgical Instrument Service and Savings Inc.(Dba Medline Ren

K-Number K153745

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LEJ 2016-05-02

HEX tanning booth

Applicant J & B Products Ltd Dba Hex Tanning

K-Number K152336

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FFX 2016-05-01

EndoFLIP

Applicant Crospon, Ltd.

K-Number K160725

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ODE 2016-05-01

EsophyX® Z Device with SerosaFuse Fasteners and Accessories

Applicant Endogastric Solutions, Inc.

K-Number K160960

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OLO 2016-04-29

Alphatec Navigation Instruments

Applicant Alphatec Spine, Inc.

K-Number K153603

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BYE 2016-04-29

Besmed PEEP Valve

Applicant Besmed Health Business Corp

K-Number K160112

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DZE 2016-04-29

Blue Sky Bio Zygomatic Implant System

Applicant Blue Sky Bio, LLC

K-Number K153064

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KGI 2016-04-29

TBS iNsight

Applicant Medimaps Group SA

K-Number K152299

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HWC 2016-04-29

OsteoBullet Compression Screw

Applicant Phalanx Innovations

K-Number K160304

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