BEUDAMED
    9 results · 24ms · Sources: EU EUDAMED, US FDA

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    CD HORIZON Spinal System, IPC POWEREASE System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    POWER WHEELCHAIR

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    AIM ACCURACY IN MARKING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    SPRINT QUATTRO

    FDA Adverse Event
    Injury ·MPRI·Product code LWS·June 8, 2013

    HEARTSTREAM FR2

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS (HTST)·Product code MKJ·June 21, 2011

    LASIK

    FDA Adverse Event
    Injury ·Product code LZS·September 8, 2008

    ASAHI CONQUEST PRO 9-40

    FDA Adverse Event
    Malfunction ·ASAHI INTECC CO., LTD.·Product code DQX·April 27, 2016

    BIOMET 3i, PROVIDE PROTECTION CAP, Catalog # PPC484, PPC485, PPC654, and PPC655 BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional Abutments are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support a prosthesis in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non-occlusal loading of provisional restorations.

    FDA Enforcement
    Class II ·Terminated·Biomet 3i, LLC·January 13, 2016

    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