BEUDAMED
    13 results · 23ms · Sources: EU EUDAMED, US FDA

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    Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NEO IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    I-STAT 1 WIRELESS ANALYZER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 6, 2025

    PS FEMORAL COMPONENT CLOSED BOX LGE RIGHT 74 MM CEMENTED

    FDA Adverse Event
    Malfunction ·BIOMET SPAIN, S.L.·Product code JWH·June 3, 2020

    ZEPHYR XL DR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC. CRMD·Product code DXY·January 13, 2014

    ENDURANCE FOLDING WALKER

    FDA Adverse Event
    Malfunction ·COM-BRIDGE INTERNATIONAL CO., LTD·Product code ITJ·May 30, 2013

    DAILY ACTIVITY ASSIST DEVICES

    FDA Adverse Event
    Malfunction ·INVACARE·Product code IKX·June 28, 2011

    PERF CON TIB BRG LRG 22X60

    FDA Adverse Event
    Injury ·BIOMET SPAIN, S.L.·Product code KRR·August 13, 2020

    NON-POROUS PERF TIB TRAY-LGE

    FDA Adverse Event
    Injury ·BIOMET SPAIN, S.L.·Product code KRR·August 13, 2020

    PERF ANAT TIBIAL STEM 120X14X5

    FDA Adverse Event
    Injury ·BIOMET SPAIN, S.L.·Product code KRR·August 13, 2020

    I-STAT TROPONIN (CTNI) CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code MMI·February 8, 2023

    UNKNOWN JOINT REPAIR DEVICE

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code MBI·July 18, 2023