BEUDAMED
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    VASCU-PICC AND MIDLINE CATHETERS, SINGLE, DOUBLE AND TRIPLE LUMEN

    FDA 510(k)
    FDA Class 2 ·General Hospital

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707065777·INTRAORAL ELASTICS 6,5 oz 1/8" brown

    IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGE

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

    SECURE RELINE/PICKUP MATERIAL

    FDA 510(k)
    FDA Class 2 ·Dental

    PROMOTE RE CRT-D

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL INC., CRMD·Product code NIK·January 13, 2014

    PANORAMA CENTRAL STATION/TELEPACK

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

    SILVERHAWK® PLAQUE EXCISION SYSTEM

    FDA Adverse Event
    Injury ·EV3 INC·Product code MCW·May 17, 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

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012