BEUDAMED
    19 results · 17ms · Sources: EU EUDAMED, US FDA

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    PHOTOMETRIC METHOD, IRON (NON-HEME) (75JIY)

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Halo Buttress Plate

    FDA UDI
    Nuvasive, Inc.·00887517727947·ALIF Buttress Plate Bender

    ReLine

    FDA UDI
    Nuvasive, Inc.·00195377035264·RELINE-C Counter Torque, Cross Connect

    Elite Orthopaedics

    FDA UDI
    Elite Orthopaedics, Inc.·00816591013400·Adjustable Elbow Brace, Right

    Elite Orthopaedics

    FDA UDI
    Elite Orthopaedics, Inc.·00816591013394·Adjustable Elbow Brace, Left

    Ventilator, High Frequency

    FDA Pre-Market Approval
    FDA Class 3 ·MODEL APT 1010 ULTRAHIGH FREQUENCY VENTILATOR

    REMY Medical Therapy Laser System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    EASY ON-PC SPIROMETER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Ventilator, High Frequency

    FDA Pre-Market Approval
    FDA Class 3 ·MODEL APT 1010 ULTRAHIGH FREQUENCY VENTILATOR

    Ventilator, High Frequency

    FDA Pre-Market Approval
    FDA Class 3 ·MODEL 1010 ULTRAHIGH FREQUENCY VENTILATOR

    Ventilator, High Frequency

    FDA Pre-Market Approval
    FDA Class 3 ·MODEL APT 1010 ULTRAHIGH FREQUENCY VENTILATOR

    Ventilator, High Frequency

    FDA Pre-Market Approval
    FDA Class 3 ·MODEL APT 1010 ULTRAHIGH FREQUENCY VENTILATOR

    Ventilator, High Frequency

    FDA Pre-Market Approval
    FDA Class 3 ·MODEL 1010 ULTRAHIGH FREQUENCY VENTILATOR

    Ventilator, High Frequency

    FDA Pre-Market Approval
    FDA Class 3 ·MODEL APT 1010 ULTRAHIGH FREQUENCY VENTILATOR

    ENDOSCOPIC CURVED INTRALUMINAL

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC.·Product code GDW·June 2, 2014

    SCULPTRA

    FDA Adverse Event
    Injury ·SANOFIAVENTIS U.S. LLC·Product code LMH·November 2, 2010

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 28, 2012

    Pipeline Flex Embolization Device

    FDA Enforcement
    Class I ·Ongoing·Micro Therapeutics Inc,·September 15, 2021

    OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012