BEUDAMED
    7 results · 19ms · Sources: EU EUDAMED, US FDA

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    MODEL KY PACEMAKER LEAD - VARIOUS

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    ST AIA-PACK CA 125 ENZYME IMMUNOASSAY

    FDA 510(k)
    FDA Class 2 ·Immunology

    SPARTAN RX CYP2C19 TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    PRECISION SPECTRA

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 21, 2014

    HARMONIC ACE 36 CM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC (CINCINNATI)·Product code LFL·November 30, 2007

    IMPLANT PDS3000M 6PK PILLAR PALATAL

    FDA Adverse Event
    Injury ·XOMED MFG JACKSONVILLE·Product code LRK·October 29, 2012

    Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

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