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

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    Dental Handpiece, Model CA160, CA160L, and CA500L

    FDA 510(k)
    FDA Class 1 ·Dental

    ambiT® "PreSet" Ambulatory Infusion Pump

    FDA UDI
    Avanos Medical, Inc.·00193494001483·ambIT* PreSet* v1.5 System w/Spike Filter Cass

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180121102·5 MM DIA., 33 CM INSULATED CONE ELECTRODE, W/ R...

    MEDIKRO SPIROSTAR, M929 Medikro Spirostar USB and M921 Medikro SpiroStar DX

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    APPLIED URETERAL CATHETER

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

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 13, 2025

    11X10MM THRD SHIELDED TROCAR W/UNIVERSAL SEAL

    FDA Adverse Event
    Other ·APPLIED MEDICAL RESOURCES·Product code GCJ·October 30, 2008

    FOLFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·August 23, 2011

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 11, 2013

    Syngo.via and Syngo.x ; a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·June 10, 2015

    Syngo.via picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·September 28, 2016

    Syngo.x picture archiving and communication system Syngo.x is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·September 28, 2016

    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