BEUDAMED
    9 results · 20ms · Sources: EU EUDAMED, US FDA

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    MODIFICATION TO BODYSTAT 1500MDD BODY COMPOSITION MONITORING UNIT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VBR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    COOK PRESSURE MONITORING CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    T25 STARDRIVE SHAFT F/MATRIX STANDARD

    FDA Adverse Event
    Injury ·SYNTHES MONUMENT·Product code HXX·April 29, 2013

    ECHELON*FLEX60 COMPACT ARTICULATING ENDOSCOPIC LINEAR CUTTER, 60 MM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·May 9, 2011

    CYPHER SIROLIMUS - ELUTING CORONARY STENT

    FDA Adverse Event
    Injury ·CORDIS DE MEXICO·Product code NIQ·July 24, 2008

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

    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

    Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018