BEUDAMED
    16 results · 26ms · Sources: EU EUDAMED, US FDA

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    TDX SP2 POWER WHEECHAIR

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Biomet® Knee System

    FDA UDI
    Biomet Orthopedics, LLC·00880304232938·

    POLAR WAND

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    COOLTOUCH MODEL CT3PZ, COOLTOUCH CT3 PLUS COOLBREEZE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.·Product code FOZ·December 28, 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·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

    CS100

    FDA Adverse Event
    Death ·DATASCOPE CORP.·Product code DSP·May 30, 2013

    NC QUANTUM APEX PTCA DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·June 27, 2011

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·September 3, 2008

    UNSPECIFIED PRIMARY PLUM SET

    FDA Adverse Event
    Malfunction ·ICU MEDICAL COSTA RICA LTD.·Product code FPA·October 3, 2024

    UNSPECIFIED PRIMARY PLUM SET CLAVE PORT, CLAVE Y-SITE, SECURE LOCK

    FDA Adverse Event
    Malfunction ·ICU MEDICAL COSTA RICA LTD.·Product code FPA·November 24, 2024

    PKG, 5MM X 45CM, INSERT, KELLY FORCEPS, P/N 0250080753 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    Philips Allura (Model Numbers 722010, 722012, 722026, 722027, 722028, 722029, 722035) and Philips Azurion (Model Numbers 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228) running StentBoost Live (Model Number 459801781661) Software Version Number: R2.0

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·April 13, 2022