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

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    LUNA-VUE DENTAL OPERATING LIGHT

    FDA 510(k)
    FDA Class 1 ·Dental

    NAR

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209131235·

    Symmetry Rhoton®

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00887482031414·Rhoton® Elevator, General Purpose, Blunt, Small...

    ACUMED

    FDA UDI
    Acumed LLC·10806378051005·Half-Size Instrument Tray

    MILLENNIUM

    FDA UDI
    Avalign Technologies, Inc.·00190776354985·R-Type Elevator, Curved

    LOCI CARDIAC TROPONIN I CALIBRATOR, MODEL RC621

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SYSMEX R-500

    FDA 510(k)
    FDA Class 2 ·Hematology

    ARCHITECT C8000 SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING INC·Product code JGS·August 23, 2011

    GYNECARE GYNEMESH* PS

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTO·October 23, 2012

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 27, 2007

    840 VENTILATOR

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY NELLCOR·Product code CBK·April 25, 2014

    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