BEUDAMED
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    LPS UNIVERSAL TIBIAL HINGE INSERTS, MODEL 198727012-198727331

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450264102·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450795934·

    TOOTH SHADE RESIN MATERIAL

    FDA 510(k)
    FDA Class 2 ·Dental

    HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL #M4735A

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    3M TEGADERM ALGINATE AG SILVER DRESSING

    FDA Adverse Event
    Injury ·3M HEALTH CARE·Product code FRO·June 21, 2016

    DUROM US ACETABULAR COMPONENT 50/44 J

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·May 4, 2011

    PANORAMA CENTRAL STATION

    FDA Adverse Event
    Malfunction ·MINDRAY DS USA, INC·Product code MHX·April 30, 2013

    GRANUFLO

    FDA Adverse Event
    Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·August 28, 2014

    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