BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    NOVA GAUZE(R) DISPOSABLE NONWOVEN SPONGES, STERILE

    FDA 510(k)
    FDA Class 2 ·Neurology

    MEGA PLUS MIS SPINE SYSTEM

    FDA UDI
    BK MEDITECH CO.,LTD.·08809665582409·MIS Cannulated Screw, Ø5.5 x 30mm, Ø5.5mm Rod

    CARBON DIOXIDE LASER SYSTEMS W/WAVEGUIDE DELIVERY

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

    PURITAN-BENNETT COMPANION 500 LIQUID OXYGEN SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SOLETRA

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code MHY·November 5, 2010

    REPLY

    FDA Adverse Event
    Malfunction ·SORIN CRM S.R.L.·Product code NVZ·January 10, 2013

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES·Product code LZG·February 26, 2014

    BIOMET StageOne Knee Tibial Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 433175.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020