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

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    Sydney IVF Cryopreservation Kit, Sydney IVF Thawing Kit

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    STAXX(R) XD SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ALIGNRT

    FDA 510(k)
    FDA Class 2 ·Radiology

    CAPSURE SP

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·June 7, 2013

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 8, 2014

    PLUM A+ 3 MEDNET SW

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·June 24, 2011

    BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE

    FDA Adverse Event
    Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FPA·July 3, 2018

    BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE

    FDA Adverse Event
    Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FPA·May 22, 2018

    Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·April 9, 2014

    ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023

    Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020. Additional kits produced through February 19, 2020 were included.

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·February 26, 2020