BEUDAMED
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    MODIFICATION TO HENSCHKE HDR CERVIX APPLICATOR AND HILARIS/NORI HDR CERVIX APPLICATOR

    FDA 510(k)
    FDA Class 2 ·Radiology

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707065692·INTRAORAL ELASTICS 4,5 oz 3/16" green

    LOCATOR R-Tx

    FDA UDI
    Zest Anchors, LLC·00840481123757·LOCATOR R-Tx Attachment System, Straumann Tissu...

    LOCATOR F-Tx

    FDA UDI
    Zest Anchors, LLC·00840481123528·LOCATOR F-Tx Abutment for Wide Neck (WN) Connec...

    LOCATOR R-Tx

    FDA UDI
    Zest Anchors, LLC·00840481128554·LOCATOR R-Tx Abutment, Straumann Tissue Level, ...

    DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS)

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    DORNIR LC-1 CPAP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SYNCARDIA COMPANION 2 DRIVER

    FDA Adverse Event
    Malfunction ·SYNCARDIA SYSTEMS, INC.·Product code LOZ·March 11, 2013

    9611369-2008-00323

    FDA Adverse Event
    Malfunction ·Product code KDI·April 28, 2008

    CONTAK RENEWAL

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·April 6, 2011

    Philips and Laerdal brands of HeartStart HS1 Defibrillator Family Model number M5066A, M5067A, and M5068A Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA. The HS1 Defibrillator is intended to treat ventricular fibrillation, the most common cause of sudden cardiac arrest. Using voice prompts, light emitting diodes (LEDs) and buttons, the user is guided through the response. The HS1 uses a SMART biphasic, impedance compensating exponential waveform to deliver a nominal 150 J to adults and nominal 50 J to infants/children.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems North America Co. Phillips·January 16, 2013

    Depuy brand ACE trochanteric nail; sterile, long, right hip, 390 x 9 x 130; Product 926209360.

    FDA Recall
    Terminated ·Depuy Orthopaedics, Inc.·Product code HSB·December 11, 2003

    Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD Inc.·December 18, 2019