BEUDAMED
    7 results · 25ms · Sources: EU EUDAMED, US FDA

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    ENCOR BIPOLAR ACT/FIXA LEAD W/POR SUR ELE #329-201

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    SURGICAL INSTRUMENTS & ACCESSORIES

    FDA 510(k)
    FDA Class 1 ·Dental

    CARDIOTOMY RESERVOIR BCR-2000

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 16, 2014

    HEARTSTART MRX - EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE·Product code MKJ·October 11, 2010

    INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·December 14, 2012

    Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024