BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    MIC-KEY GLOW PROFILE GASTROSTOMY REPLACEMENT KIT

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

    HM70A Diagnostic Ultrasound System

    FDA 510(k)
    FDA Class 2 ·Radiology

    S-FILE, S-FINDER, S-ENGINE FILE

    FDA 510(k)
    FDA Class 1 ·Dental

    ORTHOLOCK EX-PIN 3X110

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code HAW·February 28, 2013

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·February 9, 2011

    TRILOGY 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC.·Product code CBK·July 2, 2014

    INFLATOR KIT 18INFKIT BALLOON

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED INC.·Product code LRC·August 15, 2014

    Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024