BEUDAMED
    8 results · 34ms · Sources: EU EUDAMED, US FDA

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    THERMA-SHIELD

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BD DIRECTIGEN EX FLU A+B

    FDA 510(k)
    FDA Class 2 ·Microbiology

    TPN NUTRITION BAG (EVA), EMPTYING TUBE, BAG SYRINGE FILL SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ASR ACETABULAR IMPLANT 60

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·May 9, 2014

    GORE VIABAHN ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES·Product code NIP·October 10, 2012

    OT ULTRA2 METER

    FDA Adverse Event
    Injury ·LIFESCAN, INC.·Product code NBW·August 16, 2010

    PROPONENT DR SL (Model L201)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    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