BEUDAMED
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    ULTHERA SYSTEM

    FDA Adverse Event
    Injury ·ULTHERA, INC., MERZ DEVICE INNOVATION CENTER·Product code OHV·October 3, 2017

    Aquilion Lightning CT System iStation cover, SID: 70000246, Item Code: TSX-0354A/2D.03 Product Usage: Aquilion Lightning is a multislice helical CT system that supports whole-body imaging. The system employs Toshibas innovative dose-reduction technologies and a fast reconstruction unit designed to minimize the patient exposure dose and improve the workflow. The wide range of advanced applications is designed for operators of all levels of experience, maximizing performance. This device is indicated to acquire and display cross-sectional volumes of the whole body, to include the head. The Aquilion Lightning has the capability to provide volume sets. These volume sets can be used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician.

    FDA Enforcement
    Class II ·Terminated·Toshiba American Medical Systems Inc·May 4, 2016

    X-PAC

    FDA Adverse Event
    Injury ·EXPANDING INNOVATIONS, INC.·Product code MAX·December 22, 2021

    FC 500 WITH CXP SOFTWARE

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code LXG·November 21, 2007

    GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES·Product code NIO·August 5, 2019

    TALAR COMP,SINGLE COATED US VERS SMALL, LEFT

    FDA Adverse Event
    Injury ·STRYKER GMBH·Product code NTG·October 1, 2015

    TIBIAL COMP,SINGLECOATED US VERSION, LARGE

    FDA Adverse Event
    Injury ·STRYKER GMBH·Product code NTG·October 1, 2015

    DAVINCI XI

    FDA Adverse Event
    Injury ·INTUITIVE SURGICAL, INC·Product code NAY·June 3, 2022

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES, INC.·Product code MIH·March 11, 2026

    Biograph 40 TruePoint, Biograph PET/CT Scanner, Catalog No. 10097303, Manufactured by Siemens Medical Solutions USA, Inc., 810 Innovation Drive, Knoxville, TN 37932 USA, TEL: 865-218-2534

    FDA Recall
    Terminated ·Siemens Medical Solutions USA Inc·Product code KPS·July 23, 2007

    Biograph 16, Biograph PET/CT Scanner, Catalog No. 872858, Manufactured by Siemens Medical Solutions USA, Inc., 810 Innovation Drive, Knoxville, TN 37932 USA, TEL: 865-218-2534

    FDA Recall
    Terminated ·Siemens Medical Solutions USA Inc·Product code KPS·July 23, 2007

    Biograph DUO LSO, Biograph PET/CT Scanner, Catalog No. 8728813, Manufactured by Siemens Medical Solutions USA, Inc., 810 Innovation Drive, Knoxville, TN 37932 USA, TEL: 865-218-2534

    FDA Recall
    Terminated ·Siemens Medical Solutions USA Inc·Product code KPS·July 23, 2007

    Biograph 40 - 3 Ring, Biograph PET/CT Scanner, Catalog No. 10097233, Manufactured by Siemens Medical Solutions USA, Inc., 810 Innovation Drive, Knoxville, TN 37932 USA, TEL: 865-218-2534

    FDA Recall
    Terminated ·Siemens Medical Solutions USA Inc·Product code KPS·July 23, 2007

    Biograph 64-3 Ring, Biograph PET/CT Scanner, Catalog No. 8727450, Manufactured by Siemens Medical Solutions USA, Inc., 810 Innovation Drive, Knoxville, TN 37932 USA, TEL: 865-218-2534

    FDA Recall
    Terminated ·Siemens Medical Solutions USA Inc·Product code KPS·July 23, 2007

    Biograph 6, Biograph PET/CT Scanner, Catalog No. 8728854, Manufactured by Siemens Medical Solutions USA, Inc., 810 Innovation Drive, Knoxville, TN 37932 USA, TEL: 865-218-2534

    FDA Recall
    Terminated ·Siemens Medical Solutions USA Inc·Product code KPS·July 23, 2007

    Biograph 6, Biograph PET/CT Scanner, Catalog No. 8728573, Manufactured by Siemens Medical Solutions USA, Inc., 810 Innovation Drive, Knoxville, TN 37932 USA, TEL: 865-218-2534

    FDA Recall
    Terminated ·Siemens Medical Solutions USA Inc·Product code KPS·July 23, 2007

    Aquilion Lightning CT System iStation cover, SID: 70000246, Item Code: TSX-0354A/2D.03 Product Usage: Aquilion Lightning is a multislice helical CT system that supports whole-body imaging. The system employs Toshibas innovative dose-reduction technologies and a fast reconstruction unit designed to minimize the patient exposure dose and improve the workflow. The wide range of advanced applications is designed for operators of all levels of experience, maximizing performance. This device is indicated to acquire and display cross-sectional volumes of the whole body, to include the head. The Aquilion Lightning has the capability to provide volume sets. These volume sets can be used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician.

    FDA Recall
    Terminated ·Toshiba American Medical Systems Inc·Product code JAK·April 12, 2016

    IMRIS ORT100 (Part Number 110470-000) and ORT200 (Part Number 112216-00), are tables used in both the Neuro II-SE and Neuro III-SV Magnetic Resonance Imaging Systems.

    FDA Recall
    Terminated ·Innovative Magnetic Resonance Imaging Systems Inc.·Product code LNH·October 19, 2012

    IMRIS ORT100 (Part Number 110470-000) and ORT200 (Part Number 112216-00), are tables used in both the Neuro II-SE and Neuro III-SV Magnetic Resonance Imaging Systems.

    FDA Enforcement
    Class II ·Terminated·Innovative Magnetic Resonance Imaging Systems Inc.·November 28, 2012

    Acorn Regulatory Consultancy Services Ltd

    Authorized representative
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