BEUDAMED
    14 results · 23ms · Sources: EU EUDAMED, US FDA

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    ENDO SMART BOTTLE, RINSE AND INSUFFLATION SYSTEM

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

    ForPro

    FDA UDI
    Tng Worldwide, Inc.·00672047001298·Black Vinyl Exam Gloves Size X-Large 100ct

    FLIGHT 60 VENTILATOR, MODEL F-60

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    R-TEST EVOLUTION 3

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ADMINISTRATION SET FOR HALO AMBULATORY INFUSION PUMP (TRADE NAME NIMBUS FLEX)

    FDA Adverse Event
    Malfunction ·INFUTRONIX, LLC·Product code FPA·November 21, 2018

    ADMINISTRATION SET FOR HALO AMBULATORY INFUSION PUMP (TRADE NAME NIMBUS FLEX)

    FDA Adverse Event
    Malfunction ·INFUTRONIX, LLC·Product code FPA·November 21, 2018

    ADMINISTRATION SET FOR HALO AMBULATORY INFUSION PUMP (TRADE NAME NIMBUS FLEX)

    FDA Adverse Event
    Malfunction ·INFUTRONIX, LLC·Product code FPA·November 21, 2018

    ADMINISTRATION SET FOR HALO AMBULATORY INFUSION PUMP (TRADE NAME NIMBUS FLEX)

    FDA Adverse Event
    Malfunction ·INFUTRONIX LLC·Product code FPA·October 30, 2017

    CORE UNIVERSAL DRIVER

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code ERL·May 31, 2013

    TEMP PUMP TEMPERATURE

    FDA Adverse Event
    Malfunction ·STRYKER CORP DBA GAYMAR·Product code ILO·June 15, 2011

    ACCU-CHEK ® FLEXLINK INFUSION SET

    FDA Adverse Event
    Injury ·ROCHE DIAGNOSTICS·Product code FPA·October 3, 2014

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

    C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100 C/D, Clinac 2300C/D, Clinac 21EX, Clinac 23EX with versions 7, 8, 9 and 6 MV configuration and maximum dose rate of at least 6000 MU/min only. Varian High Energy Linear Accelerator is intended to provide sterotactic radiosurgery and precision radio-therapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·September 24, 2014