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

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    HYDRAGAMMA 16

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    MGB Alert® JCV Primer Mix ASR - 48 Reactions

    FDA UDI
    Elitechgroup Mdx LLC·03661540950346·"MGB Alert® JC Virus Primer Mix contains chemic...

    AcQMap

    FDA UDI
    ACUTUS MEDICAL, INC.·00857042007333·Power Cord, Console 2.0

    ACUMED

    FDA UDI
    Acumed LLC·10806378043321·3.0mm Easyout, QR

    Cortera

    FDA UDI
    Xtant Medical Holdings, Inc.·00840311232543·Driver, NAV, Poly, Shaft, Solid

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756016131·STRAP ARM SLING

    Life Instruments

    FDA UDI
    Life Instrument Corporation·M930780060100·Jacobson Forceps, 6 1/4, bayonet, 1mm, jaw 0.4m...

    LumiCare Caries Diagnostic Rinse

    FDA 510(k)
    FDA Class 2 ·Dental

    ERGO++ VERSION 1.7

    FDA 510(k)
    FDA Class 2 ·Radiology

    PYRAMESH® IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code EZX·July 17, 2014

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE CANADA KIRKLAND·Product code IOR·May 8, 2014

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

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

    KINETRA

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code MHY·August 12, 2010

    PYRAMESH IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code EZX·December 9, 2016

    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

    PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017