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

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    3DVH

    FDA 510(k)
    FDA Class 2 ·Radiology

    Oticon

    FDA UDI
    Oticon A/S·05707131259240·NERA PRO, KIT 10 OMNI 85 BE

    VIEWRAY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    SPINERX-LDM

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    INTELLIVUE MX500 PATIENT MONITOR

    FDA Adverse Event
    Death ·PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH·Product code MHX·December 4, 2023

    10FR X 55" ENTRIFLEX W/STYLET

    FDA Adverse Event
    Injury ·COVIDIEN·Product code FPD·October 1, 2014

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 29, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 16, 2011

    ENDOWRIST

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC·Product code NAY·July 16, 2020

    Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·November 29, 2017

    cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015