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

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    HUMAN IGD KIT FOR USE ON SPAPLUS

    FDA 510(k)
    FDA Class 2 ·Immunology

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B16740924500·

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B1674092450060·

    GENUA MENOPAUSE MONITOR TEST KIT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    DIAMEDIX IS-ANTI-CARDIOLIPIN IGA TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Immunology

    SOL-MILLENNIUM

    FDA Adverse Event
    Malfunction ·SOL-MILLENNIUM MEDICAL INC·Product code FMF·May 16, 2025

    FR MARSEILLE

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DTZ·December 22, 2010

    FREESTYLE AORTIC ROOT BIOPROSTHESIS

    FDA Adverse Event
    Injury ·HEART VALVES SANTA ANA·Product code LWR·May 3, 2013

    R SERIES DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·September 5, 2014

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 2, 2011

    UNK

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DTZ·July 22, 2011

    FR VILLEURBANNE

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DTZ·December 22, 2010

    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

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015