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

EHD 2017-01-24

EzRay Air W

Applicant VATECH Co., Ltd.

K-Number K163705

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HSB 2017-01-24

ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System

Applicant Orthofix Srl

K-Number K161466

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ODP 2017-01-24

nvc

Applicant Nvision Biomedical Technologies, LLC

K-Number K170074

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LON 2017-01-24

VITEK 2 AST-GN Tigecycline (<0.5->8 ug/mL)

Applicant bioMerieux, Inc.

K-Number K163006

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LZA 2017-01-24

Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (White); Dark Violet Blue (DVBU); Dark Blue (DKBU)

Applicant Hartalega Sdb. Bhd.

K-Number K162924

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GEX 2017-01-24

eLyx-PRO

Applicant Intelligent Sensory Concept SA

K-Number K162851

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BZD 2017-01-24

F&P InfoSmart

Applicant Fisher & Paykel Healthcare, Ltd.

K-Number K161686

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HSB 2017-01-24

AOS Small Bone Nailing System

Applicant Advanced Orthopaedic Solutions, Inc. (Aos)

K-Number K163014

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JLW 2017-01-23

Elecsys TSH assay, cobas e 801 Immunoassay analyzer

Applicant Roche Diagnostics

K-Number K162606

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NKB 2017-01-23

Facilis™ Spinal System

Applicant Baui Biotech Co., Ltd.

K-Number K161231

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OLO 2017-01-23

OrthAlign Plus System

Applicant Orthalign, Inc.

K-Number K162962

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NDN 2017-01-23

CONCORD Plus Radiopaque Bone Cement

Applicant Globus Medical, Inc.

K-Number K162618

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