BEUDAMED
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    DIMENSION TNI FLEX REAGENT CARTRIDGE, AND CTNI SAMPLE DILUENT WITH MODELS, RF621, KD692

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Harvard Temp C&B Pro A3

    FDA UDI
    Harvard Dental International GmbH·EHAR70816431·Temporary crown and bridge material 4:1

    VARIS 1.4G

    FDA 510(k)
    FDA Class 2 ·Radiology

    SCORPIO CR SUPERFLEX TIBIAL INSERT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PRECICE® INTRAMEDULLARY LIMB LENGTHENING ROD

    FDA Adverse Event
    Injury ·ELLIPSE TECHNOLOGIES, INCORPORATED·Product code HSB·April 29, 2013

    HEARTSTART MRX-EMS DEFIBRILLATOR

    FDA Adverse Event
    Death ·PHILIPS HEALTHCARE·Product code MKJ·April 28, 2011

    NEUROFORM 3 STENT SYSTEM

    FDA Adverse Event
    Injury ·NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP·Product code NJE·July 23, 2008

    Femoral Nail, A/R T2 Femur ¿10x320 mm, Product Number 18251032S

    FDA Enforcement
    Class II ·Terminated·Stryker GmbH·July 18, 2018

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018