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

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    AIM (N/A)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·00636257142677·30-40 MFW VITALITY CALF CT CHOC VII

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·00636257126127·30-40 MV FOR MEN CLSC CALF STD BRN VII

    OSSEOFLEX SB

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TEM 3000 HEAD COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·October 27, 2023

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code IOR·November 10, 2014

    FLEXOR SHUTTLE TIBIAL GUIDING SHEATH

    FDA Adverse Event
    Malfunction ·COOK, INC.·Product code DYB·August 9, 2011

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·July 17, 2013

    UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. Product Usage: Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.

    FDA Enforcement
    Class II ·Terminated·Zimmer Surgical Inc·November 12, 2014