BEUDAMED
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    FDA 510(k)
    FDA Class 1 ·Dental

    NXSTAGE PUREFLOW SL

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

    128 CHANNEL EEG HEADBOX, MODEL EX-NW-128

    FDA 510(k)
    FDA Class 2 ·Neurology

    COAGUCHEK ® XS SYSTEM

    FDA Adverse Event
    Injury ·ROCHE DIAGNOSTICS·Product code GJS·May 8, 2014

    BIPAP VISION

    FDA Adverse Event
    Malfunction ·PHILIPS RESPIRONICS INC.·Product code MNT·September 20, 2012

    REPLY

    FDA Adverse Event
    Injury ·SORIN BIOMEDICA C.R.M., S.R.L.·Product code NVZ·August 10, 2010

    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

    Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021