BEUDAMED
    16 results · 23ms · Sources: EU EUDAMED, US FDA

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    GE LIGHTSPEED 7.2 CT SCANNER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    PRIME-DENT VISIBLE LIGHT CURE PIT & FISSURE SEALANT

    FDA 510(k)
    FDA Class 2 ·Dental

    FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code NIQ·April 30, 2009

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code NIQ·July 2, 2010

    VANGUARD BEARING COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·August 20, 2018

    VANGUARD TIBIAL TRAY COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·August 20, 2018

    VANGUARD FEMORAL COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·August 20, 2018

    ASR ACETABULAR IMPLANT 54

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·April 29, 2013

    LINOX SD 65/16

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

    AFFINITY 4

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

    OPTIFLUX 180NR DIALYZER FINISHED ASSMBLY

    FDA Adverse Event
    Malfunction ·OGDEN MANUFACTURING PLANT·Product code KDI·July 21, 2018

    OPTIFLUX 180NRE DIALYZER FINISHED ASSMBLY

    FDA Adverse Event
    Malfunction ·OGDEN MANUFACTURING PLANT·Product code KDI·August 13, 2018

    OPTIFLUX 180NR DIALYZER FINISHED ASSMBLY

    FDA Adverse Event
    Malfunction ·OGDEN MANUFACTURING PLANT·Product code KDI·July 27, 2018

    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