BEUDAMED
    11 results · 26ms · Sources: EU EUDAMED, US FDA

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    RTM SYSTEM (REMOTE TEMPERATURE MONITOR)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    NAR

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209123674·KIT, K9 RUF w' CELOX ADVANCED - BLK

    KAWASUMI LABORATORIES IV ADMINISTRATION SET, PRIMARY

    FDA 510(k)
    FDA Class 2 ·General Hospital

    OPTIBOND XTR

    FDA 510(k)
    FDA Class 2 ·Dental

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 8, 2014

    14V POWER MODULE PATIENT CABLE

    FDA Adverse Event
    Malfunction ·THORATEC CORP.·Product code DSQ·October 18, 2012

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 25, 2007

    ARCHITECT C8000 SYSTEM

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

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021

    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