BEUDAMED
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    PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    Gyrus ACMI

    FDA UDI
    Gyrus ACMI, LLC·00821925017382·SHEA CAP DENSE HYDROXYLAPATITE

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694046435·PrimaLIF LLIF PEEK Implant, 9mm X 26mm X 60mm, ...

    WDS X-POD AND ZEN-X DIGITAL X-RAY SENSORS

    FDA 510(k)
    FDA Class 2 ·Dental

    ROYAL IMPERIAL NITRILE EXAMINATION GLOVES TEXTURED POWDER-FREE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    NI

    FDA Adverse Event
    Injury ·ADVANCED BIONICS, LLC·Product code MCM·May 24, 2013

    SYNCHROMED

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·June 21, 2011

    BHR

    FDA Adverse Event
    Injury ·SMITH & NEPHEW ORTHOPAEDICS LTD. UK·Product code KWY·August 28, 2008

    TOTAL KNEE REPLACEMENT

    FDA Adverse Event
    Malfunction ·STANMORE IMPLANTS WORLDWIDE LTD·Product code KRO·November 10, 2016

    PATIENT SPECIFIC TOTAL FEMUR

    FDA Adverse Event
    Injury ·STANMORE IMPLANTS WORLDWIDE·Product code KRO·August 15, 2018

    VNGD CR TIB BRG 10X71/75

    FDA Adverse Event
    Malfunction ·BIOMET ORTHOPEDICS·Product code JWH·November 2, 2017

    C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100 C/D, Clinac 2300C/D, Clinac 21EX, Clinac 23EX with versions 7, 8, 9 and 6 MV configuration and maximum dose rate of at least 6000 MU/min only. Varian High Energy Linear Accelerator is intended to provide sterotactic radiosurgery and precision radio-therapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·September 24, 2014