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

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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KGO 2017-01-23

Powder Free Nitrile Surgical Glove, Sterile, Tested for use with Chemotherapy Drugs

Applicant Wrp Asia Pacific Sdn. Bhd.

K-Number K161823

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MQH 2017-01-23

EZ-Tip Singles, EZ-Tip Vial of 20, EZ-Grip

Applicant Research Instruments Limited

K-Number K161275

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HRN 2017-01-23

D.O.R.C. Disposable Cryo Probe

Applicant Dutch Ophthalmic Research Center International BV

K-Number K160591

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HIS 2017-01-23

Lifestyles Zero Lubricated Latex Male Condom

Applicant Ansell Healthcare Products, LLC

K-Number K163107

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NBW 2017-01-19

UniStrip1 Generic Blood Glucose Test Strips

Applicant Ok Biotech Co., Ltd.

K-Number K162430

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