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

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    Magnetic Reasonance Imaging System

    FDA 510(k)
    FDA Class 2 ·Radiology

    AGC TRADITION KNEE SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304240902·

    AGXO

    FDA UDI
    Oticon A/S·05707131284341·H110V2 TI, BTE 13 WL 85 CBE AGXO

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·June 10, 2020

    MODIFICATION TO: CD HORIZON(R) SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MAS IMMUNOSUPPRESSANT CONTROLS

    FDA 510(k)
    FDA Class 1 ·Clinical Toxicology

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·January 5, 2018

    E1 ACTIVE ARTICULATION HEAD 28MM ID X 38MM OD

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code LPH·July 6, 2011

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MALTA·Product code FPA·June 6, 2013

    NATRELLE

    FDA Adverse Event
    Malfunction ·ALLERGAN·Product code FWM·September 19, 2014

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code NKB·April 19, 2019

    Precise Digital Accelerator Delivery of radiation to defined target volumes

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·September 26, 2012

    Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1 Used as part of radiation therapy treatment process.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·March 20, 2013

    Precise Treatment Table. To be used as part of radiation therapy treatment process.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·April 17, 2013

    All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·March 12, 2014

    Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020