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

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    CARTO™ 3 EP Navigation System V8.4

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    APEX Revision Knee

    FDA UDI
    Omni Life Science, Inc.·00841690124719·Modular Offset Stem 9mm x 75mm x 2mm

    Amendia Stand-Alone Cervical System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DATEX-OHMEDA NETWORK AND ICENTRAL '05, SALES REVISION 4.3

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ACCESS 2 IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code MMI·September 9, 2011

    UPHOLD

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OTP·October 28, 2014

    ALTRX +4 NEUT 36IDX52OD

    FDA Adverse Event
    Injury ·DEPUY-RAYNHAM, A DIV. OF DEPUY ¿ REG. # 1219655·Product code LPH·July 29, 2013

    Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

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