BEUDAMED
    9 results · 26ms · Sources: EU EUDAMED, US FDA

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    FDA 510(k)
    FDA Class 2 ·Radiology

    Thermo Scientific Oxoid Lefamulin Disc (20µg) LMU20

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Medtronic Model 53401 External Pulse Generator (EPG)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CUP: MPACT 3DMETAL ACETABULAR SHELL 48 TWO-HOLE

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·July 28, 2020

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP.·Product code FRN·January 9, 2014

    FREESTYLE

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code NBW·October 2, 2007

    REVO MRI SURESCAN

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code LWP·October 31, 2012

    BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray. The Invuity Brite Field Illuminated Suction Device is intended to aspirate from the surgical site and to provide illumination from a high intensity light source.

    FDA Enforcement
    Class II ·Terminated·Invuity, Inc.·October 10, 2012

    Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·September 30, 2015