BEUDAMED
    9 results · 18ms · Sources: EU EUDAMED, US FDA

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    AXYA MODEL 6500 AXYALOOP SELF-TAPPING BONE ANCHOR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BEAVER

    FDA Adverse Event
    Malfunction ·BEAVER-VISITEC INTERNATIONAL, INC.·Product code HNN·March 31, 2023

    COMBISON 301 PW ULTRASOUND SYSTEM AND TRANSDUCERS

    FDA 510(k)
    FDA Class 2 ·Radiology

    MACHNET CAROTIDS COIL ARRAY ASSEMBLY

    FDA 510(k)
    FDA Class 2 ·Radiology

    TALENT THORACIC

    FDA Adverse Event
    Death ·MEDTRONIC IRELAND·Product code MIH·April 11, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 2, 2014

    SELOX ST 60

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code NVZ·March 15, 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