BEUDAMED
    12 results · 26ms · Sources: EU EUDAMED, US FDA

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    MONOJECT PLASTIC HUB SPINAL NEEDLE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Tranquil-C™

    FDA UDI
    NEXUS SPINE, L.L.C.·B6788226300·Cervical Trial, Thin Shaft, 9x14x12, 6 deg

    Legacy

    FDA UDI
    Gc Orthodontics America Inc.·E53582263000001·LEGACY 1. MOLAR UPR LFT SZ 30

    IN:C2 SPINAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MODIFICATION TO FOCUS

    FDA 510(k)
    FDA Class 2 ·Dental

    INTELLIS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·February 19, 2026

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 21, 2014

    RIA DRIVESHAFT L360

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code KTT·November 7, 2012

    HS HAND CONTROLLED CURVED SHEA

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code GEI·November 27, 2007

    EV3 Pipeline Flex Embolization Device with Flex Shield Technology

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

    Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

    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