BEUDAMED
    9 results · 29ms · Sources: EU EUDAMED, US FDA

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    STRATUS CS D-DIMER CALPAK CALIBRATOR, MODEL CDDMR-C

    FDA 510(k)
    FDA Class 2 ·Hematology

    HYBRID FS & HYBRID FS TORIC (HYCOFOCON A) RGP CONTACT LENS FOR DAILY WEAR

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    VARICES INJECTION NEEDLE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    BD VACUTAINER ECLIPSE BLOOD COLLECTION NEEDLE

    FDA Adverse Event
    Injury ·BECTON, DICKINSON & CO., (BD)·Product code FMF·January 26, 2021

    PULSE GEN MODEL 105

    FDA Adverse Event
    Malfunction ·CYBERONICS INC·Product code LYJ·March 27, 2013

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·August 20, 2014

    T-LINK DATA MANAGEMENT SYSTEM

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DWA·February 24, 2011

    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

    Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024