BEUDAMED
    11 results · 20ms · Sources: EU EUDAMED, US FDA

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    TEMPORARY C&B COMPOSITE

    FDA 510(k)
    FDA Class 2 ·Dental

    MODIFICATION TO E-SCAN

    FDA 510(k)
    FDA Class 2 ·Radiology

    G-MM, MODEL 10038

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    BD ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH LUER ADAPTER

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code FMI·December 4, 2017

    SPECTRA WAVEWRITER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 20, 2023

    21 G X 1.25 IN BD ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH LUER ADAPTER

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code FMI·November 27, 2017

    PASSPORT 2 MONITOR

    FDA Adverse Event
    Malfunction ·MINDRAY DS USA, INC.·Product code DSI·April 30, 2013

    PULSE GE MODEL 102

    FDA Adverse Event
    Death ·CYBERONICS, INC.·Product code LYJ·August 20, 2014

    FLEXTEND

    FDA Adverse Event
    Death ·CPI - DEL CARIBE·Product code NVN·May 17, 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