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

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    BARD PCA II PUMP WITH PROGRAM CARTRIDGES

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ALLthread Titanium

    FDA UDI
    Biomet Orthopedics, LLC·00880304465466·

    MODIFICATION TO STAT PROFILE PHOX PLUS ANALYZER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    COLOR LCD MONITOR, MODEL RADIFORCE RS210

    FDA 510(k)
    FDA Class 2 ·Radiology

    HS III PROXIMAL SEAL

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code DXC·May 9, 2014

    RIATA ACTIVE FIXATION

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

    ASKU

    FDA Adverse Event
    Death ·MEDTRONIC MILACA INC.·Product code DTE·November 18, 2010

    IPC® HANDPIECE - XPS® STRAIGHTSHOT® M4

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED INC.·Product code ERL·February 13, 2017

    UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·August 13, 2025

    PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017

    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