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

GCJ 2016-02-12

Arthrex Synergy UHD4 System

Applicant Arthrex, Inc.

K-Number K153218

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JOH 2016-02-12

ProTrach Dualcare

Applicant Atos Medical AB

K-Number K151404

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DQX 2016-02-12

Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 Guidewire

Applicant Boston Scientific Corporation

K-Number K152231

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LLL 2016-02-12

QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 Ciontrols

Applicant Inova Diagnostics, Inc.

K-Number K151429

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GAT 2016-02-12

HS SutureTape

Applicant Riverpoint Medical

K-Number K153307

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LZA 2016-02-12

Powder Free Nitrile Patient Examination Gloves, Blue Color

Applicant Suqian Xingye Glove Co,Ltd

K-Number K151680

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GEX 2016-02-12

Tranberg CLS Laser Fiber

Applicant Clinical Laserthermia Systems, AB

K-Number K151569

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FGE 2016-02-12

X-Suit NIR Biliary Metallic Stent

Applicant Medinol, Ltd.

K-Number K150487

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LRC 2016-02-12

Relieva Scout Multi-Sinus Dilation System

Applicant Acclarent, Inc.

K-Number K153341

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LLZ 2016-02-12

TraumaCad Mobile Release 2.0

Applicant Voyant Health, Ltd.

K-Number K160001

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HWC 2016-02-12

MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws, Merete Cannulated HCS, DuoThread Scarf Screws and TwistCut Snap-Off Screws

Applicant Merete Medical GmbH

K-Number K152187

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DPS 2016-02-12

Digital Electrocardiograph

Applicant Shenzhen Biocare Bio-Medical Equipment Co., Ltd.

K-Number K160092

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