BEUDAMED
    14 results · 37ms · Sources: EU EUDAMED, US FDA

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    XPRESSE INJECTION SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code HWC·January 4, 2016

    LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ROSSMAX MEDIPRO MODEL 10 AND 60, MEDICARE MODEL 10 AND 60 BLOOD PRESSURE MONITORS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LUX 1440

    FDA Adverse Event
    Malfunction ·PALOMAR MEDICAL TECHNOLOGIES, INC.·Product code GEX·May 5, 2012

    MECHANICAL WALKER, ROLLATOR

    FDA Adverse Event
    CONSMA·Product code ITJ·April 29, 2013

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·May 10, 2011

    AMPLATZ GUIDEWIRE

    FDA Adverse Event
    BOSTON SCIENTIFIC·Product code KOG·July 24, 2008

    PROGREAT

    FDA Adverse Event
    Malfunction ·TERUMO MEDICAL CORPORATION·Product code DQO·March 5, 2024

    TERUMO PROGREAT CATHETER

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DQO·February 6, 2023

    PROGREAT CATHETER

    FDA Adverse Event
    Malfunction ·TERUMO MEDICAL CORPORATION·Product code DQO·January 6, 2024

    PROGREAT

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DQO·April 15, 2025

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

    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