BEUDAMED
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    SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    EPD 60000 RPM

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HWE·June 27, 2017

    DRILL BIT Ø1.8 F/MATMAND L125 2FLUTE F/0

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code DZI·September 3, 2013

    CABLE 3M TO CONSOLE

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HWE·October 16, 2014

    Bard® Dimension® Stone Basket

    FDA UDI
    C. R. Bard, Inc.·00801741066832·Bard® Dimension® Stone Basket

    REMEEX SYSTEM FOR URINARY INCONTINENCE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    PVS BASIC 2; EPIC 2

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    VITALITY 2

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 9, 2013

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORP.·Product code LZG·March 15, 2011

    INSIGNIA PLUS

    FDA Adverse Event
    Injury ·CARDIAC PACEMAKERS, INC·Product code DXY·May 8, 2008

    CIVCO lnfiniti Needle Guide Bracket. used for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers. Product Usage: The bracket and disposable guide provide physicians with a tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers.

    FDA Enforcement
    Class II ·Terminated·Civco Medical Instruments Co. Inc.·August 29, 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