BEUDAMED
    8 results · 18ms · Sources: EU EUDAMED, US FDA

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    P.F.C. MODULAR KNEE SYSTEM, TIBIAL TRAY-POROUS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Hi-Fatigue Bone Cement

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SIRCAM 106

    FDA 510(k)
    FDA Class 2 ·Radiology

    PWRD ECH FLEX 60MM 34CM SHAFT

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·June 24, 2014

    HEARTSINE SAMARITAN 300P AND PAD PAK

    FDA Adverse Event
    Malfunction ·HEARTSINE TECHNOLOGIES, LTD·Product code MKJ·November 30, 2012

    MESH - COMPOSIX KUGEL

    FDA Adverse Event
    Death ·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·November 3, 2010

    Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty

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

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015