BEUDAMED
    11 results · 21ms · Sources: EU EUDAMED, US FDA

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    COSENSE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    NOVO Health Services, LLC

    FDA UDI
    NOVO HEALTH SERVICES, LLC·00812564032409·Set Up Pack, CMC Large

    CALYPSO SYSTEMS WITH DYNAMIC EDGE GATING

    FDA 510(k)
    FDA Class 2 ·Radiology

    MIE SCINTRON GAMMA CAMERA SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Radiology

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code LXH·February 10, 2020

    STAR TOTAL ANKLE REPLACEMENT

    FDA Adverse Event
    Injury ·SMALL BONE INNOVATIONS, INC.·Product code HSN·May 10, 2013

    ANIMAS INSULIN CARTRIDGE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·September 26, 2014

    ACCESS 2 IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·May 20, 2011

    LUCAS 3 CHEST COMPRESSION SYSTEM

    FDA Adverse Event
    Death ·JOLIFE AB - 3005445717·Product code DRM·February 6, 2024

    LUCAS 3 CHEST COMPRESSION SYSTEM

    FDA Adverse Event
    Death ·JOLIFE AB - 3005445717·Product code DRM·February 6, 2024

    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty

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