BEUDAMED
    9 results · 17ms · Sources: EU EUDAMED, US FDA

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    DISPOSABLE CATHETER PRESSURE TRANSDUCER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GC Initial™

    FDA UDI
    Gc America Inc.·J0228741651·GC Initial™ Ti Correction Powder COR, 20g

    GC Initial™

    FDA UDI
    Gc America Inc.·15400556703912·GC Initial™ Ti Correction Powder COR, 20g

    MBK SURGEONS'(STERILE & NON-STERILE) SURG GLOVES

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

    SYRINGE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES·Product code LZG·April 23, 2014

    ACCU-CHEK ® AVIVA TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·October 19, 2010

    VERTEBRAL BODY STENT ACCESS KIT

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code ODP·December 14, 2012

    Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty

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