BEUDAMED
    10 results · 36ms · Sources: EU EUDAMED, US FDA

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    FITBONE(R) TAA

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SONOSITE HAND-CARRIED ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    EBI XFIX DFS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PRECISION

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·January 2, 2022

    BINAXNOW COVID-19 ANTIGEN SELF-TEST

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·September 28, 2022

    ACCLAIM ENCORE

    FDA Adverse Event
    Malfunction ·HOSPIRA, INC.·Product code FRN·October 15, 2008

    INSYNC SENTRY

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code NIK·August 11, 2011

    HEARTMATE II LVAS

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·July 2, 2013

    Spacelabs Healthcare elance Vital Signs Monitor, Model 93300, with Option S. It is a patient monitor with arrhythmia detection or alarms.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare, Llc·November 20, 2013

    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