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

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    DIAZYME LIQUID STABLE ENZYMATIC SODIUM ASSAY, MODEL DZ114B

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SORIN BIOMEDICA SMART BCD VANGUARD,SURFACE MODIFIED BLOOD CARDIOPLEGIA SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    REMREST

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    RADIFOCUS OPTITORQUE

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DQX·June 13, 2022

    ACUITY

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code OJX·April 29, 2013

    LUMAX 340 VR-T

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code MRM·April 29, 2011

    4 MOTOR ADVANCE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·July 23, 2008

    HEARTMATE 3 TUNNELING LANCE AND HANDLE

    FDA Adverse Event
    Malfunction ·THORATEC CORPORATION·Product code DSQ·December 13, 2024

    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