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

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    O&P BIVALVE CRANIAL MOLDING HELMET

    FDA 510(k)
    FDA Class 2 ·Neurology

    LIFEJET VIDEO LINK

    FDA 510(k)
    FDA Class 2 ·Radiology

    GEN-PROBE APTIMA COMBO 2 ASSAY

    FDA 510(k)
    FDA Class 2 ·Microbiology

    DIMENSION VISTA® CLINICAL CHEMISTRY SYSTEM

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC-BROOKFIELD·Product code CGA·April 17, 2013

    MESH - COMPOSIX KUGEL

    FDA Adverse Event
    Injury ·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·June 19, 2008

    VOYAGER RX CORONARY DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code LOX·April 19, 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

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015