BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    INOMAX DS (DELIVERY SYSTEM), MODEL 10003

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    GLUCOBALANCE DATA MANAGEMENT SOFTWARE, MODEL 555020

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ARAMIS DERMATLOGIC LASER

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·May 3, 2013

    MATTRESS COVER FOR MEDICAL PURPOSES

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code FMW·September 16, 2014

    OMNISPAN MENISCAL FASTENER

    FDA Adverse Event
    Injury ·DEPUY MITEK·Product code MBI·May 3, 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

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015