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

NKG 2016-09-06

Xenco Medical Posterior Cervical System

Applicant Xenco Medical, LLC

K-Number K161478

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MAX 2016-09-06

Nanovis Intervertebral Body Fusion System and Forticore(R)

Applicant Nanovis, LLC

K-Number K161485

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NUC 2016-09-06

Mano and Mano Personal Lubricant

Applicant Mano and Mano Proprietary Limited

K-Number K161585

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OWB 2016-09-05

SyncVision System

Applicant Volcano Corporation

K-Number K161756

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DQK 2016-09-03

CardioConfirm

Applicant Mortara Instrument, Inc.

K-Number K161465

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MMX 2016-09-02

Indy OTW Vascular Retriever

Applicant Cook Incorporated

K-Number K160593

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KWQ 2016-09-02

Tangis Anterior Cervical Plate

Applicant Nvision Biomedical Technologies, LLC

K-Number K161524

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OWI 2016-09-02

LigaPASS

Applicant Medicrea International SA

K-Number K160698

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IYN 2016-09-02

MyLabSix Ultrasound System

Applicant Esaote Europe B.V.

K-Number K161168

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PGN 2016-09-02

MAGEC® Spinal Bracing and Distraction System

Applicant Nuvasive Specialized Orthopedics, Inc.

K-Number K161751

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JPA 2016-09-02

Sysmex Automated Blood Coagulation Analyzer CS-5100

Applicant Siemens Healthcare Diagnostics Products GmbH

K-Number K161317

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FCG 2016-09-02

Perineologic Access Needle

Applicant Corbin Clinical Resources, LLC

K-Number K160423

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