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

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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LYC 2016-09-14

OSTEON III

Applicant Genoss Co., Ltd.

K-Number K153676

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OLO 2016-09-14

TSolution One Cup1 Surgical System

Applicant THINK Surgical, Inc.

K-Number K162195

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MOS 2016-09-14

dS FootAnkle I6CH 1.5T Coil

Applicant Invivo Corporation

K-Number K162177

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FRO 2016-09-14

Anexa Wound Flush, Sterile Water & Sterile Normal Saline

Applicant Anexa Biomedical, Inc.

K-Number K161658

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IYN 2016-09-14

CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System

Applicant Philips Health Care

K-Number K162329

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HAW 2016-09-14

StealthStation System with Cranial Software

Applicant Medtronic Navigation, Inc.

K-Number K153660

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DYB 2016-09-13

TXM Guiding Sheath

Applicant Texasmedical Technologies, Inc.

K-Number K153771

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