BEUDAMED
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    MAGNETOM Viato.Mobile

    FDA 510(k)
    FDA Class 2 ·Radiology

    RIGIDLOOP

    FDA UDI
    S.B.M·03760304680199·The RIGIDLOOP device consists of a titanium but...

    BARRICADE EMBOLIZATION COIL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Hematology

    PEN NEEDLE 31GX5MM 14 PACK

    FDA Adverse Event
    Malfunction ·EMBECTA MEDICAL DEVICES (SUZHOU) CO., LTD., CHINA·Product code FMI·August 28, 2024

    MESH - VENTRALEX

    FDA Adverse Event
    Injury ·DAVOL INC·Product code FTL·August 25, 2011

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL MANUFACTURING CORPORATION·Product code MVK·September 17, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 18, 2013

    Volcano Pioneer Plus Re-Entry Catheter; Product Code PPLUS20, Catheter for Crossing Total Occlusions. Cardiovascular: The Volcano Pioneer Plus Intravascular Ultrasound Re-Entry Catheter (Pioneer Plus) is intended to facilitate the placement and positioning of catheters within the peripheral vasculature.

    FDA Recall
    Terminated ·Volcano Corporation·Product code PDU·July 22, 2015

    HRIS ACET CUP CUT TIP 32X140 Part Number: 6210-5-200rker. single-use, sterile surgical instruments used during hip arthroplasty

    FDA Recall
    Open, Classified ·Howmedica Osteonics Corp.·Product code LXH·December 22, 2023

    HRIS ACET CUP CUT TIP 26X140 Part Number: 6210-5-100. single-use, sterile surgical instruments used during hip arthroplasty

    FDA Recall
    Open, Classified ·Howmedica Osteonics Corp.·Product code LXH·December 22, 2023

    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