BEUDAMED
    9 results · 20ms · Sources: EU EUDAMED, US FDA

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    Anker II Dental Implant System

    FDA 510(k)
    FDA Class 2 ·Dental

    SBI AUTOFIX

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ENDOCHOICE WATER BOTTLE CAP SYSTEM

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

    SYMBIQ SINGLE CHANNE

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·October 6, 2014

    SPECTRAFLEX

    FDA Adverse Event
    Injury ·MEDTRONIC, B.V.·Product code DTB·June 7, 2013

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 22, 2011

    SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·January 28, 2026

    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

    Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·July 22, 2015