BEUDAMED
    9 results · 29ms · Sources: EU EUDAMED, US FDA

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    Unicel DxH 800 Coulter Cellular Analysis System

    FDA 510(k)
    FDA Class 2 ·Hematology

    ONE TOUCH BASIC ENHANCED

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·January 7, 2002

    PURESOM NASAL MASK-SMALL, PURESOM NASAL MASK-MEDIUM, PURESOM NASAL MASK-LARGE, MODELS 11924-01, 11924-02, 11924-03

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SERIES II X3 LARGE DIAMETER ACCETABULAR INSERTS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEPTH GAUGE FOR 2.7MM & SMALL SCREWS

    FDA Adverse Event
    Malfunction ·SYNTHES BRANDYWINE·Product code HTJ·April 10, 2017

    NAVILYST MEDICAL / VAXCEL

    FDA Adverse Event
    Malfunction ·NAVILYST MEDICAL·Product code LJS·October 7, 2008

    PROGRAMMING SOFTWARE

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·July 22, 2011

    GRAFTON DBM

    FDA Adverse Event
    OSTEOTECH, INC. (SUBSIDIARY OF MEDTRONIC)·Product code NUN·June 27, 2013

    REF 101-05-40***NOVATION MODULAR DRILL BIT LENGTH: 40mm, DIAMETER 3.2mm***Use with 40mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gainesville, FL 32653***. To assist the surgeon in the implantation of Novation Hip system components in according to a conventional technique for hemi & total hip arthroplasty. Specifically, these instruments are reusable, surgically invasive, and intended for transient use.

    FDA Enforcement
    Class II ·Terminated·Exactech, Inc.·September 19, 2012