BEUDAMED
    240 results · 30ms · Sources: EU EUDAMED, US FDA

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    ORIA SPINAL CLIP SYSTEM, SACRAL CONNECTOR, MODELS CA03 AND AO03

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DANMAR PRODUCTS CRANIAL ADJUSTIVE PROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Neurology

    CAVEX STABISIL

    FDA 510(k)
    FDA Class 2 ·Dental

    1031452-2015-15732

    FDA Adverse Event
    Malfunction ·August 28, 2015

    1031452-2018-00014

    FDA Adverse Event
    Death ·December 4, 2018

    1031452-2016-03262

    FDA Adverse Event
    Malfunction ·August 10, 2016

    1031452-2015-14068

    FDA Adverse Event
    Malfunction ·June 4, 2015

    BED EXTENDER 9153650579

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code FNL·April 26, 2016

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 22, 2014

    BARIATRIC BED HEAD 9153641516

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code OSI·February 22, 2016

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 6, 2013

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·June 21, 2013

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code FNL·April 25, 2013

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 26, 2013

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code FNL·September 6, 2013

    MECHANICAL WALKER, ROLLATOR

    FDA Adverse Event
    UNKNOWN·Product code ITJ·March 5, 2013

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·June 4, 2013

    Temporary Total Artificial Heart (TAH-t) with Freedom Driver System REF 595000-001 Product Usage: Freedom Drivers are components of the SynCardia temporary Total Artificial Heart (TAH-t) System, which is indicated for use in transplant-eligible candidates at risk of imminent death from biventricular failure. Freedom Drivers are intended for use in and out of the hospital.

    FDA Enforcement
    Class I ·Terminated·SynCardia Systems Inc.·September 23, 2015

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·June 19, 2013

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code FNL·April 22, 2013