BEUDAMED
    11 results · 28ms · Sources: EU EUDAMED, US FDA

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    DIMENSION I REFRACTION SYSTEM

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    VITROS

    FDA UDI
    ORTHO-CLINICAL DIAGNOSTICS, INC.·10758750001354·VITROS Chemistry Products TRFRN Reagent

    ACUMED

    FDA UDI
    Acumed LLC·10806378089947·Distal Humeral Broach, Small

    DIAMEDIX IS-CMV IGM CAPTURE TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    AMNISURE FETAL MEMBRANES RUPTURE TEST, MODEL FMRT-1

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    COBAS C 303 ANALYTICAL UNIT

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·January 28, 2025

    COBAS C 503 ANALYTICAL UNIT

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·March 20, 2025

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 8, 2014

    EON MINI

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL NEUROMODULATION·Product code LGW·October 17, 2012

    RENAL - DISPOSABLE

    FDA Adverse Event
    Injury ·Product code FKX·August 16, 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