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

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    SELECTIVE BROTH

    FDA 510(k)
    FDA Class 1 ·Microbiology

    INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH STRAUMANN TISSUE LEVEL IMPLANTS

    FDA 510(k)
    FDA Class 2 ·Dental

    POWERED WHEELCHAIR, MODEL C-1000

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·May 30, 2014

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·November 21, 2012

    BALLOON UTERINE STENT

    FDA Adverse Event
    Injury ·COOK UROLOGICAL, INC.·Product code KNA·September 10, 2010

    GLOBAL UNITE STD STEM SZ 10 Part Number: 110010100

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·January 19, 2022

    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

    Various convenience packs

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems, Inc.·September 14, 2022