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

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    AXIOS Stent and Delivery System

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

    APEX Revision Knee

    FDA UDI
    Omni Life Science, Inc.·00841690124467·Modular Offset Stem 15mm x 75mm x 2mm

    ANSPACH KNOTLESS ANCHOR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    IYUNNI 3ID SUPRAPUBIC CYSTOSTOMY TUBE KIT

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

    BASIX COMPAK INFLATION SYRINGE KIT

    FDA Adverse Event
    Malfunction ·MERIT MEDICAL SYSTEMS, INC.·Product code DTL·March 14, 2011

    PENUMBRA SMART COIL

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code HCG·December 11, 2015

    PLMA DVC V11.51 1 R

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

    CAPSUREFIX

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

    TERUMO PERFUSION SYSTEM 8000

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEM CORP.·Product code JOR·June 27, 2011

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code MRU·October 27, 2015

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code MHY·October 29, 2015

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code MRU·October 28, 2015

    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

    Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10F (722002), Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013), Allura Xper FD20 OR Table (722015, 722023, 722035), Allura Xper FD20 Biplane OR Table (722025), Allura Xper FD20/10 (722029), Allura Xper FD20/15 (722058), Allura Xper FD20/15 OR Table (722059), Allura Xper FD20/20 (722038), Allura Xper FD20/20 OR Table (722039), Cardio Vascular-Allura (722400);

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 27, 2026