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

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    BLACKSTONE SPINAL FIXATION SYSTEM SPACER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Reicodent

    FDA UDI
    devemed GmbH·04061644048304·Mouth mirror handle | M 2.5 Hollow handle

    MODIFICATION TO CD HORIZON SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MODIFICATION TO ELECSYS FSH II CALSET

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    EON MINI

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 22, 2013

    TOTALCARE

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·February 16, 2011

    BIOLOGIC

    FDA Adverse Event
    Malfunction ·BIO-LOGIC SYSTEMS CORPORATION·Product code GWQ·March 12, 2008

    Exactech Equinoxe REVERSE SHOULDER,36mm Constrained Humeral Liner: a) +0mm, Item Number 320-36-10, b) +2.5mm, Item Number 320-36-13; Shoulder Arthroplasty

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

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014

    The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018