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

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    iRestore

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Masel

    FDA UDI
    Ortho Organizers, Inc.·00190707041113·Choice™ Crown and Band Crimpling Pliers

    ProLift

    FDA UDI
    Life Spine, Inc.·00190837106270·Static Expandable Cage Trial, 10mm x 28mm x 13m...

    SYNAPSE 3D BASIC TOOLS

    FDA 510(k)
    FDA Class 2 ·Radiology

    VINYL NITRILE CO-POLYMER POWDER FREE EXAM GLOVES (BLUE COLOR)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    ENTERRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LNQ·July 5, 2016

    ANSPACH® XMAX

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code ERL·October 8, 2014

    DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE

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

    ACCU-CHEK SPIRIT COMBO

    FDA Adverse Event
    Injury ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·June 28, 2011

    OPEN-END FLEXI-TIP URETERAL CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KOD·February 6, 2020

    OPEN-END URETERAL CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KOD·February 7, 2020

    OPEN-END URETERAL CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KOD·December 5, 2019

    DUROM ACETABULAR COMPONENT 52/46 CODE L

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·April 28, 2017

    Philips Azurion 7M20 systems with FlexArm ceiling-mounted system, Interventional Fluoroscopic X-Ray System, Model Numbers 722079 and 722224

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·September 11, 2024

    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 Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025

    Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025