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

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    BOUGIE A BOULE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Preat

    FDA UDI
    Preat Corporation·00842092110867·Sphero Flex/Block Driver

    RIVA BOND

    FDA UDI
    SDI LIMITED·DO3688006111·

    ACUMED

    FDA UDI
    Acumed LLC·10806378043420·Removal Tip Wrench

    iNSitu™ Hip System

    FDA UDI
    NEXTSTEP ARTHROPEDIX, LLC·00816127026751·Shortened Dual Taper Broach, Size 11

    MESA SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    STELLER CD61 ASSAY FOR USE ON THE IMAGN 2000 MICROVOLUME FLUORIMETER

    FDA 510(k)
    FDA Class 2 ·Hematology

    TRULIANT TIB IMP PS INSERT SZ 4 12MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·June 10, 2024

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMLERY NELLCO·Product code CBK·February 11, 2014

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 22, 2012

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC., USA·Product code LFR·September 7, 2007

    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

    ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022