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

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    1.5T AND 3.0T GENERAL PURPOSE FLEX COILS

    FDA 510(k)
    FDA Class 2 ·Radiology

    NA

    FDA UDI
    FORTEC FIBERS, INC.·00816901020081·

    WAVEWRITER ALPHA

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 9, 2024

    PRESCOTT'S SURGICAL SPEAR

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    IMMUNO-TROL LOW CELLS

    FDA 510(k)
    FDA Class 2 ·Hematology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·February 18, 2026

    HEARTMATE II SYSTEM CONTROLLER

    FDA Adverse Event
    Injury ·THORATEC CORP.·Product code DSQ·April 30, 2013

    INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code FRN·September 16, 2014

    ASR UNI FEMORAL UMPL SIZE 43

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·May 12, 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