BEUDAMED
    15 results · 32ms · Sources: EU EUDAMED, US FDA

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    Electronic stimulator

    FDA 510(k)
    FDA Class 2 ·Neurology

    StarDental Instrument Solutions

    FDA UDI
    DENTALEZ, INC.·D7022003540·CLASSIQUE DIA INSTRUMENTS 702-8P

    N/A

    FDA UDI
    STRYKER SUSTAINABILITY SOLUTIONS, INC.·00885825003159·Diagnostic EP Catheter, Cournand curve, 8 elect...

    Sonoma™

    FDA UDI
    Seaspine Orthopedics Corporation·10889981050900·Sonoma Anterior Cervical Plate 3 Level Plate, 54mm

    Manta Ray™

    FDA UDI
    Seaspine Orthopedics Corporation·10889981057183·Plate - 3 Level - 54 mm

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·July 5, 2022

    C.T.M. MOBILITY SCOOTERS HS-666, HS-730, HS-570

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    BAYLIS PAIN MANAGEMENT GENERATOR (PMG), MODELS PMG-115 (DOMESTIC), PMG-230 (INTERNATIONAL)

    FDA 510(k)
    FDA Class 2 ·Neurology

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 17, 2014

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·Product code NBW·August 11, 2011

    MECHANICAL WALKER, ROLLATOR

    FDA Adverse Event
    KENSTONE METAL·Product code ITJ·July 1, 2013

    TRUE METRIX

    FDA Adverse Event
    Malfunction ·TRIVIDIA HEALTH INC·Product code NBW·March 27, 2024

    StarDental Classique(TM) Diamond Dental Bur. Used for specific applications in dental procedures.

    FDA Enforcement
    Class II ·Terminated·Dental EZ Stardental Division·June 19, 2013

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

    FDA Enforcement
    Class II ·Terminated·Bayer Corp·June 11, 2014