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

GAW 2016-09-15

Pledgeted COR-SUTURE QUICK LOAD

Applicant Lsi Soultions

K-Number K160529

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QSZ 2016-09-15

Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen Advanced Wound Matrix, 1x6”

Applicant Engineered Tissue Solutions, LLC

K-Number K161067

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NUH 2016-09-15

HBOTC Muscle and Nerve Stimulator

Applicant Hb Medical, Inc.

K-Number K160255

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GEH 2016-09-15

Compound W Wart Removal System Dual Power

Applicant Medtech Products, Inc.

K-Number K161294

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CGA 2016-09-14

GEM Premier 3000

Applicant Instrumentation Laboratory CO

K-Number K161818

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PPS 2016-09-14

Flexitouch System

Applicant Tactile Systems Technology, Inc. (Dba Tactile Medical)

K-Number K153311

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NHA 2016-09-14

CAM Titanium Blanks

Applicant Altatec GmbH

K-Number K160784

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OVE 2016-09-14

SeaSpine Shoreline ACS - Anterior Cervical Standalone System

Applicant SeaSpine Orthopedics Corporation

K-Number K161081

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IYN 2016-09-14

EBit Series Diagnostic Ultrasound System

Applicant Chison Medical Imaging Co., Ltd.

K-Number K162172

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HEX 2016-09-14

Colposcope System

Applicant Xuzhou Kernel Medical Equipment Co., Ltd.

K-Number K160341

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PPN 2016-09-14

Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector Cable, Lithoplasty Connector Cable

Applicant Shockwave Medical, Inc.

K-Number K161384

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FRO 2016-09-14

ACTICOAT Surgical Dressing

Applicant Smith & Nephew Medical Limited

K-Number K153723

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