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

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    8ch Flex Suite

    FDA 510(k)
    FDA Class 2 ·Radiology

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814190·GENUMEDI PT SILVER L II

    AirLife

    FDA UDI
    Carefusion Corporation·70885403276561·AirLife&#8482 Connector 22 mm ID x 22 mm ID

    General Instruments

    FDA UDI
    ALPHATEC SPINE, INC.·00840180533796·DECOMPRESSION TUBE, 22mm x 70mm - DUAL NOTCH

    General Instruments

    FDA UDI
    ALPHATEC SPINE, INC.·00840180533802·DECOMPRESSION TUBE, 22mm x 90mm - DUAL NOTCH

    ONE TOUCH BASIC ENHANCED

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·April 12, 2002

    ULTIMATE VIT ENHAMCER (UVE)

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    SPY FLUORESCENT IMAGING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    ZIMMER AIR DERMATOME II HANDPIECE

    FDA Adverse Event
    Malfunction ·ZIMMER SURGICAL·Product code GFD·October 9, 2014

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 5, 2013

    7900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·June 15, 2011

    RESTORE SENSOR

    FDA Adverse Event
    Death ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·September 27, 2012

    PRIMEADVANCED

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·September 18, 2013

    Achieva 1.5T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·November 29, 2023

    LapSac Surgical Tissue Pouch. The current intended use for the LapSac Surgical Tissue Pouch is for isolating tissue during, or prior to, surgical removal and/or morcellation. The device is a reinforced pouch with an inner liner and drawstring closure. The device may be used to isolate tissue and/or act as a containment system during surgery. It is provided in a variety of sizes and has applications in the Urology, Surgery, and Reproductive Health business units.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·July 1, 2015