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

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    S.O.F.T. PADDLE (SPECIAL OPTIMIZED FULL COMPRESSION TRAY), MODEL SFT-PDLE

    FDA 510(k)
    FDA Class 2 ·Radiology

    LIFERAY FW MAMMO CASSETTE, LIFERAY KW MAMMO CASETTE

    FDA 510(k)
    FDA Class 2 ·Radiology

    BIOPATCH ANTIMICROBIAL DRESSING

    FDA 510(k)
    FDA Unclassified ·Unknown

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·January 27, 2025

    TRILOGY 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC.·Product code CBK·February 27, 2013

    ENDOPATH** ETS FLEX45

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·March 18, 2011

    VIASYS

    FDA Adverse Event
    Death ·CARDINAL HEALTH 207, INC·Product code CBK·March 28, 2008

    SMR SHOULDER SYSTEM

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code PHX·May 26, 2026

    PIPELINE FLEX EMBOLIZATION DEVICE

    FDA Adverse Event
    Injury ·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·October 20, 2025

    PHENOM CATHETER

    FDA Adverse Event
    Injury ·MICRO THERAPEUTICS, INC. DBA EV3·Product code QJP·October 20, 2025

    PIPELINE FLEX W/SHIELD TECHNOLOGY

    FDA Adverse Event
    Injury ·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·October 20, 2025

    MARKSMAN

    FDA Adverse Event
    Injury ·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRA·October 20, 2025

    PIPELINE FLEX W/SHIELD TECHNOLOGY

    FDA Adverse Event
    Malfunction ·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·October 20, 2025

    PIPELINE FLEX EMBOLIZATION DEVICE

    FDA Adverse Event
    Malfunction ·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·October 20, 2025

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018