BEUDAMED
    21 results · 31ms · Sources: EU EUDAMED, US FDA

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    GE DATEX-OHMEDA AVANCE ANESTHESIA SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ODYSSEY®

    FDA UDI
    Microport Orthopedics Inc.·M684K00711421·

    NA

    FDA UDI
    STERILMED, INC.·10888551020435·SAW BLADE OSCILLATING LARGE BONE

    ME-92

    FDA UDI
    Conmed Corporation·10845854004142·OSCILLATOR BLADE, ME-92 COATED, 25.4 X 90 X 1.2...

    AUDIO TECHNOLOGIES S:R.1

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    AQUARIUS WORKSTATION

    FDA 510(k)
    FDA Class 2 ·Radiology

    SPECTRA WAVEWRITER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 5, 2024

    HEARTSTART MRX-EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·April 8, 2013

    ENTRUST AT

    FDA Adverse Event
    Death ·MEDTRONIC MED REL, INC.·Product code LWS·April 27, 2011

    6600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·July 10, 2008

    PERCLOSE¿ PROSTYLE¿

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR INC.·Product code MGB·October 14, 2024

    TOSOH HLC-723G8 ANALYZER

    FDA Adverse Event
    Malfunction ·TOSOH CORPORATION·Product code LCP·December 20, 2017

    TOSOH HLC-723G8 ANALYZER

    FDA Adverse Event
    Malfunction ·TOSOH CORPORATION·Product code LCP·December 15, 2017

    TOSOH HLC-723G8 ANALYZER

    FDA Adverse Event
    Malfunction ·TOSOH CORPORATION·Product code LCP·December 20, 2017

    TOSOH HLC-723G8 ANALYZER

    FDA Adverse Event
    Malfunction ·TOSOH CORPORATION·Product code LCP·December 11, 2017

    TOSOH HLC-723G8 ANALYZER G8

    FDA Adverse Event
    Injury ·TOSOH CORPORATION·Product code LCP·January 5, 2016

    TOSOH HLC-723G8 ANALYZER G8

    FDA Adverse Event
    Injury ·TOSOH CORPORATION·Product code LCP·January 3, 2017

    TOSOH HLC-723G8 ANALYZER G8

    FDA Adverse Event
    Malfunction ·TOSOH CORPORATION·Product code LCP·April 16, 2018

    Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·February 28, 2018

    cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014