BEUDAMED
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    CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MODIFICATION TO:PHILIPS M3000A/M3046A COMPACT PORTABLE PATIENT MONITOR, MODELS PHILIPS M3000A/M3046A

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ZINC PHOSPHATE CEMENT

    FDA 510(k)
    FDA Class 2 ·Dental

    ALIGN TO URETHRAL SUPPORT SYSTEM

    FDA Adverse Event
    Injury ·BARD SHANNON LTD·Product code FTL·January 31, 2012

    TOTAL ASR FEM IMP SIZE 45

    FDA Adverse Event
    Injury ·DEPUY FRANCE SAS 3003895575·Product code KXA·March 27, 2013

    LEAD MODEL 302

    FDA Adverse Event
    Malfunction ·CYBERONICS INC·Product code LYJ·March 8, 2011

    GUIDANT 4.3 MM AORTIC CUTTER

    FDA Adverse Event
    Injury ·GUIDANT CARDIAC SURGERY·Product code DXC·April 2, 2008

    HEARTMATE 3 LVAS IMPLANT KIT

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·April 22, 2021

    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