BEUDAMED
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    SYNGO.MR NEUROLOGY, SYNGO.MMR GENERAL

    FDA 510(k)
    FDA Class 2 ·Radiology

    Gyrus ACMI

    FDA UDI
    Gyrus ACMI, LLC·00821925015364·MCGEE 0FF-CENTERED TORP 7 MM LENGTH, 0.8MM DIAM...

    INFINION 16

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 30, 2019

    DOVER ROB-NEL CATHETER

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

    LEGION POROUS + HA TIBIAL BASEPLATES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BDRV CANN SCW SS P/T DIA4.5X60 MM

    FDA Adverse Event
    Injury ·BIOMET SPAIN, S.L.·Product code HWC·March 7, 2017

    BDRV CANN SCW SS P/T DIA4.5X52 MM

    FDA Adverse Event
    Injury ·BIOMET SPAIN, S.L.·Product code HWC·March 7, 2017

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL·Product code MGB·May 24, 2013

    TOTALCARE

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·May 31, 2011

    BRAVO

    FDA Adverse Event
    Malfunction ·ARIZONA DEVICE MANUFACTURING·Product code FFT·August 28, 2008

    PROXIMAL TIBIA JTS (DISTAL FEMORAL COMPONENT)

    FDA Adverse Event
    Injury ·STANMORE IMPLANTS WORLDWIDE·Product code KRO·November 28, 2018

    DISTAL FEMUR JTS

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

    DISTAL FEMUR JTS / PROXIMAL TIBIA MIG

    FDA Adverse Event
    Injury ·STANMORE IMPLANTS WORLDWIDE LTD.·Product code KRO·April 7, 2015

    Varian brand Clinac, Trilogy, Novalis Tx, Unique, linear accelerators; Model Number: H14, H18, H29, Reference/FSCA Identifier: CP-08881; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA. 1) The Varian Low Energy Linear Accelerator is indicated for precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment i is indicated. (2) The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc. Oncology Systems·September 26, 2012

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012

    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

    Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment System, Model Numbers: H14, H27, H29, HCX. Product Usage: The Varian High Energy Accelerator is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc. Oncology Systems·May 22, 2013