BEUDAMED
    12 results · 21ms · Sources: EU EUDAMED, US FDA

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    KLS Martin Thoracic Plating System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Prime Medical LLC

    FDA UDI
    Prime Medical LLC·00850055249295·PrimePadPlus-K15-3422

    JOURNEY II DEEP DISHED ARTICULAR INSERTS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SUPERSTITCH GW, MODELS 06-15-04-GW, 08-15-04-GW

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

    CD HORIZON® SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO., HU·Product code KWP·October 17, 2025

    CD HORIZON BALLAST SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NKB·December 9, 2019

    CURRENT ACCEL DR

    FDA Adverse Event
    Death ·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·October 8, 2014

    ELECTRODE, PACEMAKER, PERMANENT

    FDA Adverse Event
    Malfunction ·MPRI·Product code DTB·June 8, 2013

    SOLAR 8000M MONITOR

    FDA Adverse Event
    Malfunction ·GE HEALTHCARE·Product code DSI·June 21, 2011

    ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023

    GE HC OEC 9900 Elite and GE OEC 9800 Fluoroscopes Snubber Boards are a PCB with a 70 amp fuse to provide fused protection of internal system components from the high voltage system components, such as the X-ray tube or High Voltage Transformer. System model number A349855, Snubber Board number 00-880405-03 rev 5. This product is used for image intensified fluoroscopic x-rays for interventional radiologic procedures.

    FDA Enforcement
    Class II ·Terminated·GE OEC Medical Systems, Inc·August 29, 2012

    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