BEUDAMED
    13 results · 25ms · Sources: EU EUDAMED, US FDA

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    Vivid S60N, Vivid S70N

    FDA 510(k)
    FDA Class 2 ·Radiology

    Ratchet Handle

    FDA UDI
    Treace Medical Concepts, Inc.·00810111225519·Ratcheting Straight Handle

    STEVENS TENOTOMY SCISSORS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896055131·STEVENS TENOTOMY SCISSORS LONG CURVED BLUNT TUN...

    Trial Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964092855·Trial Procedure Kit

    H-TRONPLUS

    FDA Adverse Event
    Malfunction ·DISETRONIC MEDICAL SYSTEMS, INC.·Product code LZG·May 10, 2006

    TRIDENT ELEVATED RIM LINER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VOYAGER/VIPER WHEELCHAIR

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·TANDEM DIABETES CARE·Product code LZG·March 29, 2016

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·October 24, 2014

    UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code DHA·August 11, 2011

    PRECISION®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 1, 2013

    Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

    FDA Enforcement
    Class II ·Terminated·Bayer Corp·June 11, 2014

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021