BEUDAMED
    10 results · 21ms · Sources: EU EUDAMED, US FDA

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    45L CORE INSUFFLATOR, MODEL F114

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    ORION PLATINUM

    FDA 510(k)
    FDA Class 2 ·Neurology

    CARDIOCOLLECT PORTABLE ELECTROCARDIOGRAPH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ISA CO2

    FDA Adverse Event
    Malfunction ·MASIMO - 15750 ALTON PKWY·Product code MWI·December 30, 2022

    HS III PROXIMAL SEAL SYTEM 4.3MM

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code DXC·April 11, 2013

    DIMENSION® CLINICAL CHEMISTRY SYSTEM

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC - BROOKFIELD·Product code JJE·April 19, 2011

    GORE VIABAHN ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES·Product code NIP·June 19, 2008

    BD Connecta Stopcock Without Extension Tube Catalog No. 394602 (OUS)

    FDA Enforcement
    Class II ·Ongoing·Becton Dickinson & Company·July 27, 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

    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