BEUDAMED
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    ALBAAD PLASTIC APPLICATOR TAMPONS UNSCENTED

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Merit® Kit

    FDA UDI
    Merit Medical Systems, Inc.·00884450328606·

    IMMUNICON CELLTRACKS AUTOPREP SYSTEM

    FDA 510(k)
    FDA Class 1 ·Hematology

    NELLCOR COMPATIBLE REUSABLE SPO2 SOFT-FINGER SENSOR, MODEL T100A-090103

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DORMA 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·March 16, 2022

    Widex

    FDA UDI
    Widex A/S·05706069972245·WIDEX MOMENT MBB2 440 (Shocking pink)

    Widex

    FDA UDI
    Widex A/S·05706069884531·WIDEX MOMENT MRR2D (Shocking pink ) 440, RC coi...

    Widex

    FDA UDI
    Widex A/S·05706069923445·WIDEX MOMENT MBB3D 440 (Shocking pink)

    Widex

    FDA UDI
    Widex A/S·05706069556551·Widex D-FA P (Shocking pink ) Dream 440, Teleco...

    Widex

    FDA UDI
    Widex A/S·05706069553864·Widex UNIQUE U-FA (Shocking pink ) 440, Telecoi...

    Widex

    FDA UDI
    Widex A/S·05706069671780·Widex EVOKE E-FA (Shocking pink ) 440, Telecoil...

    TRILOGY 100

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

    SYNCHRON LX® RHEUMATOID FACTOR REAGENT

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

    MATRIX2 SOFT 360 SR COIL

    FDA Adverse Event
    Death ·NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORPORATION·Product code HCG·August 30, 2008

    CABLE TENSIONER

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code LXH·August 27, 2013

    Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 25, 2019

    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