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

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    Cellvizio 100 series system with confocal Miniprobes

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

    ambIT

    FDA UDI
    SUMMIT MEDICAL PRODUCTS, INC.·00857595005350·RA PreSet Pain Control System

    ambiT® "PreSet" Ambulatory Infusion Pump

    FDA UDI
    Avanos Medical, Inc.·00193494000646·ambIT* Pain Control System - RA PreSet*

    ISOMEDIX OPERATIONS INC.

    FDA registration
    ISOMEDIX OPERATIONS INC.·281 products·🇺🇸 United States

    Flex Body Speeder

    FDA 510(k)
    FDA Class 2 ·Radiology

    AEROSYNC FOR AERODR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    SPECTRUM IQ INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·March 23, 2022

    SPECTRUM IQ INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·June 13, 2022

    SPECTRUM IQ INFUSION PUMP

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE CORPORATION·Product code FRN·May 25, 2022

    PULSE GEN MODEL 101

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·November 4, 2008

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM INC.·Product code FNL·July 18, 2011

    OT PING METER

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

    SPECTRUM IQ INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·June 16, 2022

    TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021