BEUDAMED
    8 results · 18ms · Sources: EU EUDAMED, US FDA

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    ANTIMICROBIAL SUSCEPT-CULTURE MEDIA

    FDA 510(k)
    FDA Class 2 ·Microbiology

    AMERIWATER OZONE DISINFECTION SYSTEM

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

    3DSCOPE

    FDA 510(k)
    FDA Class 2 ·Radiology

    CLINITRON RITEHITE

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code INX·February 27, 2014

    SCREW

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code NKB·November 21, 2012

    ISOLINE

    FDA Adverse Event
    Injury ·SORIN BIOMEDICA CRM·Product code MRM·September 10, 2010

    5.0mm Unit Rod 270mm, 5.0mm Unit Rod 290mm, 5.0mm Unit Rod 310mm, 5.0mm Unit Rod 330mm, 5.0mm Unit Rod 350mm, 5.0mm Unit Rod 370mm, 5.0mm Unit Rod 390mm, 5.0mm Unit Rod 410mm, 5.0mm Unit Rod 430mm, 5.0mm Unit Rod 450mm; Orthosis, Spinal, Pedicle fixation Intended to provide immobilization and stabilization of spinal segments in skeletally mature patients.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·October 28, 2015

    5.0mm Unit Rod 270mm 5.0mm Unit Rod 290mm 5.0mm Unit Rod 310mm 5.0mm Unit Rod 330mm 5.0mm Unit Rod 350mm 5.0mm Unit Rod 370mm 5.0mm Unit Rod 390mm 5.0mm Unit Rod 410mm 5.0mm Unit Rod 430mm 5.0mm Unit Rod 450mm pedicle screw spinal system; Intended to provide immobilization and stabilization of spinal segments in skeletally mature patients.

    FDA Enforcement
    Class II ·Terminated·Synthes USA HQ, Inc.·August 21, 2013