BEUDAMED
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    H-FLOW VALVE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Baltic Denture System BDLoad

    FDA UDI
    Merz Dental GmbH·D7091034043·Baltic Denture System BDLoad BDLoad ↓ Ln6 PLSEu...

    TRANSDUCER, S8-3T MICRO TEE

    FDA Adverse Event
    Malfunction ·PHILIPS ULTRASOUND, INC.·Product code IYO·August 8, 2014

    MAMMARY ASPIRATION SPECIMEN CYTOLOGY TEST

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    METAL TRANSCEND ARTICULATION SYSTEM

    FDA 510(k)
    FDA Class 3 ·Orthopedic

    TRANSDUCER, S8-3T MICRO TEE

    FDA Adverse Event
    Malfunction ·PHILIPS ULTRASOUND, INC.·Product code IYO·March 28, 2014

    TRANSDUCER, S8 3T MICRO TEE

    FDA Adverse Event
    Malfunction ·PHILIPS ULTRASOUND, INC·Product code IYO·June 27, 2014

    TRANSDUCER S8-3T MICRO TEE

    FDA Adverse Event
    Malfunction ·PHILIPS ULTRASOUND, INC.·Product code IYO·January 24, 2014

    HDI 5000 ULTRASOUND STANDARD SYSTEM

    FDA Adverse Event
    Malfunction ·PHILIPS ULTRASOUND, INC.·Product code IYO·March 30, 2012

    PRECISION®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·March 30, 2011

    ARTICUL/EZE BALL 28 +5 BR

    FDA Adverse Event
    Injury ·JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD. 3006356043·Product code JDI·August 25, 2014

    VOYAGER RX CORONARY DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code LOX·April 24, 2008

    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

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013