BEUDAMED
    9 results · 25ms · Sources: EU EUDAMED, US FDA

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    ECA GEL PROUDUCT REFORMULATION

    FDA 510(k)
    FDA Class 2 ·Neurology

    MARIETTA CONTACT LENS SERVICE, COLOR ENHANCED TINTED SOFT CONTACT LENS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    POWDERED VINYL PATIENT EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    SMR HUMERAL EXTENSION + 9 MM

    FDA Adverse Event
    Injury ·LIMACORPORATE SPA·Product code KWS·January 9, 2019

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 9, 2014

    OSV II LOW PRO

    FDA Adverse Event
    Malfunction ·INTEGRA NEUROSCIENCES IMPLANTS S.A.·Product code JXG·October 19, 2012

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 18, 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