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

EBW 2017-02-10

XSmart iQ

Applicant Dentsply Sirona

K-Number K161213

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DXN 2017-02-10

Blood Pressure Monitor

Applicant Beijing Choice Electronic Technology Co., Ltd.

K-Number K162089

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DTR 2017-02-10

MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface (Bridge System)

Applicant Medtronic, Inc.

K-Number K162774

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IYN 2017-02-10

LOGIQ P9 and LOGIQ P7

Applicant GE Healthcare

K-Number K163596

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LZO 2017-02-10

Revision Femoral Stem

Applicant Lima Corporate S.P.A.

K-Number K161226

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FMF 2017-02-10

Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH

Applicant Terumo Europe N.V.

K-Number K161606

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FRG 2017-02-10

SteriTite Containers System & MediTray Products

Applicant Case Medical, Inc.

K-Number K161415

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OXF 2017-02-10

GORE BIO-A Tissue Reinforcement

Applicant W. L. Gore & Associates, Inc.

K-Number K163217

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JDR 2017-02-10

EasyClip Xpress

Applicant Restore Surgical, LLC Dba Instratek

K-Number K162321

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KWS 2017-02-10

Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative Plan, SmartBase for Arthrex Glenoid IRIS, ArthrexVIP Web Portal

Applicant Custom Orthopaedic Solutions, Inc.

K-Number K162697

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NUC 2017-02-10

Astroglide Diamond Silicone Gel Personal Lubricant

Applicant Biofilm, Inc.

K-Number K163395

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JJW 2017-02-09

UA-Cellular Complete

Applicant Streck

K-Number K170091

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