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

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    DN ACUPUNTURE NEEDLES

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SCEPTOR GRAM-NEGATIVE BREAKPOINT/ID PANEL

    FDA 510(k)
    FDA Class 2 ·Microbiology

    SEQUEL (CASTING ALLOY FOR PORCELAIN-FUSED-METAL)

    FDA 510(k)
    FDA Class 2 ·Dental

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·June 20, 2014

    DUAL CHAMBER TEMPORARY PACEMAKER

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·February 28, 2013

    PT GRAPHIX GUIDEWIRE

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - COSTA RICA·Product code DQX·February 10, 2011

    TI LOW PROFILE SCREW 6.5X20MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·August 7, 2018

    TI LOW PROFILE SCREW 6.5X25MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·August 7, 2018

    TI LOW PROFILE SCREW 6.5X30MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·August 7, 2018

    E1 RINGLOC ACETABULAR LINER

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDI·August 7, 2018

    BIOLOX DELTA CERAMIC HEAD

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LZO·August 7, 2018

    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