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

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    ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR (NON-STERILE),ESOPHAGEAL STETHOSCOPE TEMPERATURE WITH ATTACHED EAR PIECE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·00636257125144·20-30 MV FOR MEN CLSC CALF STD TAN IV

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·00636257127278·20-30 MV FOR MEN SEL CALF STD TAN IV

    Fuji Cervical Plate System

    FDA UDI
    Altus Spine, LLC·B41711401341·34mm Level 1 Cervical Plate System - Fuji

    NC TREK RX CORONARY DILATATION CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    THERILINK BONE VOID FILLER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BD LOGIC BLOOD GLUCOSE METER

    FDA Adverse Event
    Other ·BECTON DICKINSON·Product code NBW·August 5, 2004

    COBAS 6000 CORE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·July 16, 2008

    COBAS INTEGRA 400 PLUS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JGS·April 7, 2010

    MICRONY I ISR+

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, CRMD·Product code LWP·January 13, 2014

    UNKNOWN CUSA EXCEL

    FDA Adverse Event
    Malfunction ·INTEGRA LIFESCIENCES IRELAND LIMITED·Product code LFL·May 29, 2013

    SYNCHRON® SYSTEMS RHEUMATOID FACTOR (RF) REAGENT

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code DHR·June 25, 2011

    OT ULTRA2 METER

    FDA Adverse Event
    Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 11, 2013

    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

    C-Series: Clinac, Trilogy, Trilogy Tx. , Novalis high energy linear accelerators and UNIQUE single energy linear accelerator; Versions 7, 8 and 9. The UNIQUE is not sold in the US. Product Usage: 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. The UNIQUE is a single energy medical linear accelerator. UNIQUE is indicated for precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·December 11, 2013

    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