BEUDAMED
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    SILEX SACROILIAC JOINT FUSION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Merit® Kit

    FDA UDI
    Merit Medical Systems, Inc.·00884450328620·

    DIGITAL ULTRASOUND SCANNER

    FDA 510(k)
    FDA Class 2 ·Radiology

    M.L. PRIMER

    FDA 510(k)
    FDA Class 2 ·Dental

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 12, 2024

    PRECISION

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 7, 2024

    RHEUMATOID FACTOR TEST SYSTEM

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

    TRILOGY 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC·Product code CBK·May 29, 2013

    EASY LOAD INSERTER

    FDA Adverse Event
    Injury ·BAUSCH & LOMB·Product code KYB·August 28, 2008

    CERENOVUS ENTERPRISE

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code NJE·August 26, 2025

    Custom Dialysis Kit CF-4235 Without Gel, which includes Flex-Neck Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog # K14-00079

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code OJV·September 20, 2017

    Custom Dialysis Kit CF-4235 Without Gel, which includes Flex-Neck¿ Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog # K14-00079

    FDA Enforcement
    Class II ·Terminated·Merit Medical Systems, Inc.·March 28, 2018

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 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

    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