BEUDAMED
    13 results · 39ms · Sources: EU EUDAMED, US FDA

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    HD-550 Video Endoscope System

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

    SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    LAMINAR FLOW PHACO TIPS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    BEBACK CROSSING CATHETER

    FDA Adverse Event
    Malfunction ·BENTLEY INNOMED GMBH·Product code PDU·December 23, 2025

    BEBACK CROSSING CATHETER

    FDA Adverse Event
    Malfunction ·BENTLEY INNOMED GMBH·Product code PDU·November 21, 2025

    BEBACK CROSSING CATHETER

    FDA Adverse Event
    Malfunction ·BENTLEY INNOMED GMBH·Product code PDU·April 30, 2025

    BEBACK CROSSING CATHETER

    FDA Adverse Event
    Malfunction ·BENTLEY INNOMED GMBH·Product code PDU·March 6, 2025

    OPTISTAR LE, INJ SYS, PRGM SALE

    FDA Adverse Event
    Malfunction ·LIEBEL-FLARSHEIM CO.·Product code DXT·October 23, 2008

    SYNERGY

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·August 10, 2011

    MEGA SUTURECUT NEEDLE DRIVERINSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·July 8, 2013

    Model Number L211 PROPONENT DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·January 22, 2025

    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