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

LZC 2017-11-28

Orange Non Sterile Powder Free Nitrile Examination Gloves

Applicant Central Medicare Sdn Bhd

K-Number K172642

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KLE 2017-11-28

TOKUYAMA UNIVERSAL BOND

Applicant Tokuyama Dental Corporation

K-Number K171226

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LRK 2017-11-28

Meridian PM

Applicant The Center For Craniofacial & Dental Sleep Medicine

K-Number K170053

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HQF 2017-11-27

PSLT for PASCAL Streamline

Applicant Topcon Medical Laser Systems, Inc.

K-Number K171488

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JOW 2017-11-27

Devon 51

Applicant Devon Medical Products (Jiangsu), Ltd.

K-Number K172030

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MRC 2017-11-27

Bausch + Lomb Boston Original Cleaner, Bausch + Lomb Boston Original Conditioning Solutions

Applicant Bausch & Lomb, Incorporated

K-Number K173089

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LQR 2017-11-27

Single Use Retrieval Nitinol Basket V

Applicant Olympus Medical Systems Corp.

K-Number K170811

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GXQ 2017-11-27

Cerafix Dura Substitute

Applicant Acera Surgical, Inc.

K-Number K172603

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HRS 2017-11-27

CoLink View Plating System

Applicant In2bones USA, LLC

K-Number K172300

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MAI 2017-11-27

HEALIX ADVANCE KNOTLESS Anchor

Applicant Medos International SARL

K-Number K171114

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MCW 2017-11-27

Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters

Applicant Spectranetics, Inc.

K-Number K172687

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HWC 2017-11-27

VariAx 2 System

Applicant Stryker GmbH

K-Number K173135

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