BEUDAMED
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    ALARIS PUMP MODULE

    FDA Adverse Event
    Malfunction ·CAREFUSION·Product code FRN·December 22, 2017

    ALARIS IV PUMP

    FDA Adverse Event
    Injury ·CAREFUSION 303, INC.·Product code FRN·March 8, 2024

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code MHY·July 2, 2019

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code MHY·July 2, 2019

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code MHY·July 2, 2019

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code MRU·July 2, 2019

    ALARIS SYSTEM

    FDA Adverse Event
    Injury ·CAREFUSION SD·Product code FRN·April 22, 2024

    TWIST DRILL

    FDA Adverse Event
    Injury ·KARL LEIBINGER MEDIZINTECHNIK GMBH & CO KG Q·Product code HTW·March 27, 2015

    Cream, Gloving, Surgeon'S

    FDA classification
    FDA Class 1 ·Cream, Gloving, Surgeon'S

    Trumpf Ceiling Mounted Surgical Lighting Systems,TruLight 3000/5000, User Manual #1528403. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's body with a high intensity light.

    FDA Enforcement
    Class II ·Terminated·Trumpf Medical Systems, Inc.·August 19, 2015

    Trumpf Ceiling Mounted Surgical Lighting Systems,iLED 3/5, User Manual #1558932. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's body with a high intensity light.

    FDA Enforcement
    Class II ·Terminated·Trumpf Medical Systems, Inc.·August 19, 2015

    Trumpf Ceiling Mounted Surgical Lighting Systems,Helion/Xenion S/M/L, User Manual #1441784. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's body with a high intensity light.

    FDA Enforcement
    Class II ·Terminated·Trumpf Medical Systems, Inc.·August 19, 2015

    Trumpf Ceiling Mounted Surgical Lighting Systems,TruVidia SD, User Manual #1400191. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's body with a high intensity light.

    FDA Enforcement
    Class II ·Terminated·Trumpf Medical Systems, Inc.·August 19, 2015

    Trumpf Ceiling Mounted Surgical Lighting Systems,TruVidia HD, User Manual #1513140. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's body with a high intensity light.

    FDA Enforcement
    Class II ·Terminated·Trumpf Medical Systems, Inc.·August 19, 2015

    Cala kIQ

    FDA 510(k)
    FDA Class 2 ·Neurology

    Cala kIQ

    FDA 510(k)
    FDA Class 2 ·Neurology

    Cala kIQ

    FDA 510(k)
    FDA Class 2 ·Neurology

    Kleiner KG2 System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Cala kIQ Plus

    FDA 510(k)
    FDA Class 2 ·Neurology

    KERATINOCYTE GROWTH MEDIUM (KGM)

    FDA 510(k)
    FDA Class 1 ·Hematology