BEUDAMED
    8 results · 28ms · Sources: EU EUDAMED, US FDA

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    STEREOTACTIC TARGET POSITIONER, TARGET POSITIONER FOR LEKSELL HEADRING, STEREOTACTIC COUNTERWEIGHT

    FDA 510(k)
    FDA Class 2 ·Radiology

    TITAN TIBIAL NAIL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTITIVE TEST KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    DONJOY OA NANO, MEDIAL, RT, S

    FDA Adverse Event
    Injury ·DJO, LLC·Product code ITQ·June 26, 2019

    ELECTRI-COOL II

    FDA Adverse Event
    Malfunction ·CINCINNATI SUB ZERO·Product code ILO·April 18, 2013

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 9, 2014

    ACCU-CHEK D-TRONPLUS

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·April 21, 2011

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012