BEUDAMED
    18 results · 21ms · Sources: EU EUDAMED, US FDA

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    FINN CHAMBER (R)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    neoWave LS

    FDA UDI
    XENIX MEDICAL LLC·00818345023871·BAYONETTED STRAIGHT RING CURETTE

    EZ2C

    FDA UDI
    FGX INTERNATIONAL INC.·00193033521175·

    EZ2C

    FDA UDI
    FGX INTERNATIONAL INC.·00193033521199·

    MATIRA ANTERIOR CERVICAL SYSTEM

    FDA UDI
    Kalitec Direct LLC·B07307K0130201·PLATE CALIPER

    EZ2C

    FDA UDI
    FGX INTERNATIONAL INC.·00193033521113·

    EZ2C

    FDA UDI
    FGX INTERNATIONAL INC.·00193033521182·

    DISPOSABLE CB-PE MICROKERATOME BLADES

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    DENTORIUM CONVERTIBLE ACRYLIC

    FDA 510(k)
    FDA Class 2 ·Dental

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·March 20, 2013

    MERIT CUSTOM KIT

    FDA Adverse Event
    Malfunction ·MERIT MEDICAL SYSTEMS, INC.·Product code DQO·February 4, 2011

    CUSTOM PAK

    FDA Adverse Event
    Injury ·ALCON - HOUSTON·Product code KYG·March 14, 2008

    AXIOM ARISTOS VX PLUS

    FDA Adverse Event
    Injury ·SIEMENS SHANGHAI MEDICAL EQUIPMENT LTD·Product code MQB·April 7, 2021

    SAF-T-INTIMA IV CATHETER SAFETY SYSTEM WITH PRN ADAPTER

    FDA Adverse Event
    Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·April 2, 2019

    BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM

    FDA Adverse Event
    Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·May 2, 2019

    SOLITAIRE FR4

    FDA Adverse Event
    Malfunction ·MICRO THERAPEUTICS, INC. DBA EV3·Product code NRY·January 11, 2021

    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

    Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·June 29, 2022