BEUDAMED
    11 results · 26ms · Sources: EU EUDAMED, US FDA

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    GESTATE SLIDE EIKEN KIT AGG. METHOD HUM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    VITROS

    FDA UDI
    ORTHO CLINICAL DIAGNOSTICS·10758750002764·VITROS Immunodiagnostic Products HBsAg Reagent ...

    IDR

    FDA 510(k)
    FDA Class 2 ·Radiology

    GENUA MENOPAUSE MONITOR TEST KIT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    CONSERVE(R) TOTAL HEAD W/BFH

    FDA Adverse Event
    Injury ·MICROPORT ORTHOPEDICS INC.·Product code KWA·May 9, 2014

    VASOVIEW HEMOPRO 2

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code GEI·October 18, 2012

    BV300

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code IZL·August 9, 2010

    DuraLife Autoclavable Double Swivel Elbow, REF 60-0010 (UltraSet Product Code 66-1991); Swivel Elbow with Suction Port for use with breathing circuits

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·May 24, 2023

    VITROS Immunodiagnostics Products HBsAg Reagent Pack, Catalog # 6801322: 1 Reagent Pack box per sales unit (100 tests per box), and Catalog # 6802450: 5 Reagent Pack boxes per sales unit (100 tests per box), IVD. Ortho-Clinical Diagnostics Amersham UK.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics Forest Farm Estate, Whitechurch Cardiff United Kingdom·Product code LOM·February 1, 2007

    ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022

    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