BEUDAMED
    16 results · 22ms · Sources: EU EUDAMED, US FDA

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    LOCATOR F-Tx Attachment System

    FDA 510(k)
    FDA Class 2 ·Dental

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100240·SILICONE TUBING FOR ASPIRATING SPECULUM

    REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VISANTE OCT

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    UNSPECIFIED PRIMARY PLUM SET

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

    PROGRAMMING SOFTWARE

    FDA Adverse Event
    Malfunction ·CYBERONICS INC·Product code LYJ·October 8, 2014

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE·Product code KDJ·June 7, 2013

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE·Product code KDJ·July 6, 2011

    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

    LOTUS VALVE SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code NPT·May 13, 2021

    COREVALVE TRANSCATHETER AORTIC VALVE

    FDA Adverse Event
    Death ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·August 24, 2020

    MEDTRONIC TRANSCATHETER VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·August 24, 2020

    Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1 Used as part of radiation therapy treatment process.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·March 20, 2013

    SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy treatments of malignant neoplastics diseases.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·March 26, 2014

    Precise Treatment Table. To be used as part of radiation therapy treatment process.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·April 17, 2013

    All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·March 12, 2014