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

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    COBE ICU CONVERSION KIT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MANTIS REDUX SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ELECTROENCEPHALOGRAPH SOFTWARE EEMAGINE EEG

    FDA 510(k)
    FDA Class 2 ·Neurology

    CS300

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP·Product code DSP·May 9, 2014

    RIATA ACTIVE FIXATION

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·January 8, 2013

    CONCERTO CRT-D DR

    FDA Adverse Event
    Death ·MEDTRONIC MED REL, INC.·Product code NIK·November 18, 2010

    MANTIS REDUX BLOCKER

    FDA Adverse Event
    Malfunction ·STRYKER SPINE-US·Product code NKB·November 27, 2019

    UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·August 13, 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