BEUDAMED
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    STRAUMANN DENTAL IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    n/a

    FDA UDI
    Ortho Development Corporation·00822409075508·12/14 Press-Fit Broach 14x19

    SOLAR SHOULDER OFFSET HUMERAL HEAD

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CAVEX COLORCHANGE

    FDA 510(k)
    FDA Class 2 ·Dental

    Thermage Face Tip 3.0, REF/UDI: TTNS3,00C3-400/UDI (01)000850608002377; REF TTNS3.00C3-600/UDI (01)000850608002384; REF TTNS3.00C3-900; UDI (01)000850608002391 Used in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

    FDA Enforcement
    Class II ·Terminated·Solta Medical Inc·April 15, 2020

    NDEHP PRIMARY PLUM PREPIERCED Y

    FDA Adverse Event
    Malfunction ·HOSPIRA HOLDINGS DE COSTA RICA LTD.·Product code FRN·April 25, 2013

    PERMANENT CAUTERY HOOK INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·April 26, 2013

    DEXTRUS 4136

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code NVZ·April 29, 2011

    MULTIPLE VENDORS

    FDA Adverse Event
    Injury ·Product code HSD·July 24, 2008

    HOSP SS FLEXX METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·February 22, 2011

    HOSP SS FLEXX METER W/O LASER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·May 17, 2011

    HOSP SS FLEXX METER

    FDA Adverse Event
    Death ·LIFESCAN INC.·Product code NBW·April 1, 2011

    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