BEUDAMED
    9 results · 21ms · Sources: EU EUDAMED, US FDA

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    MARK3

    FDA 510(k)
    FDA Class 2 ·Dental

    ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 5000

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FAST START TENS, MODEL FS 3001

    FDA 510(k)
    FDA Class 2 ·Neurology

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·October 3, 2014

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 3, 2013

    DEXTRUS 4135

    FDA Adverse Event
    Other ·BIOTRONIK SE & CO. KG,·Product code NVZ·June 15, 2011

    CHROMID® CARBA SMART

    FDA Adverse Event
    Malfunction ·BIOMERIEUX S.A.·Product code JSO·August 23, 2018

    STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD 100NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100NX process to inactivate microorganisms on a board range of medical devices and surgical instruments.

    FDA Enforcement
    Class II ·Terminated·Advanced Sterilization Products·April 10, 2013

    Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·November 24, 2021