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

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    VITAL SIGNS MONITOR, MODEL: MD500B

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UHMWPE COMPONENTS IN THE REFLECTION ACTABULAR SYSTEM (ACETABULAR LINE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MODEL 120, OXYSOFT, INFRARED DATA CONVERTER, MODEL 120

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 9, 2024

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·GUIDANT PUERTO RICO BV·Product code NVY·April 29, 2013

    INTERSTIM II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·May 3, 2011

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC.·Product code MKJ·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