BEUDAMED
    10 results · 19ms · Sources: EU EUDAMED, US FDA

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    PLATELET COUNTING KIT

    FDA 510(k)
    FDA Class 2 ·Hematology

    SIEMENS 1.5T TXRX 15 CH KNEE

    FDA Adverse Event
    Other ·QUALITY ELECTRODYNAMICS·Product code MOS·October 5, 2011

    ZENITH PEDICLE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TXRX 15CH KNEE COIL (1.5T AND 3T), TXRX CP EXTREMITY COIL 3T

    FDA 510(k)
    FDA Class 2 ·Radiology

    FUSION¿ ENT NAVIGATION SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·October 17, 2019

    INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·May 9, 2014

    SCREW

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·October 24, 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