BEUDAMED
    9 results · 20ms · Sources: EU EUDAMED, US FDA

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    J-FX BIPOLAR HEAD

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ISOZYME - ID CPK MARKER

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Actreen Hi-Lite Cath, Actreen Hi-Lite Set

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ENDOPATH ENDOSCOPIC MULTIFEED STAPLER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC.·Product code GAG·February 25, 1998

    IMPELLA CP

    FDA Adverse Event
    Injury ·ABIOMED, INC. - 1220648·Product code OZD·January 8, 2026

    FUSION NAVIGATION SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·February 27, 2013

    LINEAGE(R) TRANSCEND(R) CERAMIC FEMORAL HEAD

    FDA Adverse Event
    Injury ·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code MRA·February 7, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·August 5, 2014

    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