BEUDAMED
    12 results · 18ms · Sources: EU EUDAMED, US FDA

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    SureAx-Guide™

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776384111·Smith-Petersen Osteotome, 8", straight, 5/8"

    Bradshaw Medical Inc.

    FDA UDI
    Bradshaw Medical, Inc.·00810019930973·BIT, HEX FEMALE 7.0MM 1/4 SQ

    Vilex Guidewire

    FDA UDI
    VILEX IN TENNESSEE, INC.·00841731120731·Guidewire 2.0x250mm Drill Tip

    Vilex Guidewire

    FDA UDI
    VILEX IN TENNESSEE, INC.·00841731120748·Guidewire 2.0x250mm Sgl Trocar

    ALLUX

    FDA 510(k)
    FDA Class 2 ·Dental

    Medentika CAD/CAM Abutments

    FDA 510(k)
    FDA Class 2 ·Dental

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 15, 2011

    SAVI APPLICATOR

    FDA Adverse Event
    Malfunction ·CIANNA MEDICAL·Product code MIJ·September 4, 2008

    OBTRYX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 26, 2013

    BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 51 MM, Silicone, Sterile, Item 431209.

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

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013