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    Ziehm-Orthoscan Inc

    Manufacturer
    🇺🇸 United States·1 Importer

    ORTHOSCAN, INC.

    FDA registration
    ORTHOSCAN, INC.·6 products·🇺🇸 United States

    OrthoScan Mobile DI Mini C-arm

    FDA UDI
    Ziehm-Orthoscan, Inc.·B225100000050·Image-intensified fluoroscopic x-ray system, mo...

    OrthoScan Pulse Mini C-arm

    FDA UDI
    Ziehm-Orthoscan, Inc.·B22510000004FD0·Image-intensified fluoroscopic x-ray system, mo...

    TAU Model 1000-0016 Mini C-Arm

    FDA UDI
    Ziehm-Orthoscan, Inc.·B225100000160·Image-Intensified Fluoroscopic X-Ray System, Mo...

    TAU Model 1000-0017 Mini C-Arm

    FDA UDI
    Ziehm-Orthoscan, Inc.·B225100000170·Image-Intensified Fluoroscopic X-Ray, Mobile

    OrthoScan HD Mini C-arm

    FDA UDI
    Ziehm-Orthoscan, Inc.·B225100000040·Image-intensified fluoroscopic x-ray system, mo...

    TAU Model 1000-0015 Mini C-Arm

    FDA UDI
    Ziehm-Orthoscan, Inc.·B225100000150·Image-Intensified Fluoroscopic X-Ray System, Mo...

    MINI C-ARM

    FDA Adverse Event
    Malfunction ·ORTHOSCAN, INC.·Product code OXO·December 11, 2018

    ORTHOSCAN MINI C-ARM X-RAY SYSTEM FD-OR

    FDA Adverse Event
    Injury ·ORTHOSCAN, INC.·Product code OXO·July 14, 2020

    ORTHO SCAN MINI C-AM

    FDA Adverse Event
    Malfunction ·ORTHO SCAN INC.·Product code OXO·August 13, 2020

    TAU MODEL 1000-0017 MINI C-ARM

    FDA Adverse Event
    Malfunction ·ZIEHM-ORTHOSCAN, INC.·Product code OXO·March 8, 2024

    Mobile Mini C-arm system Part # 1000-0001. Intended to provide the physician with general fluoroscopic visualization of the patient, including, but not limited to, surgical orthopedic procedures and critical and emergency care procedures.

    FDA Recall
    Terminated ·Orthoscan, Inc.·Product code OXO·August 31, 2017

    Mobile Mini C-arm system Part # 1000-0005. Intended to provide the physician with general fluoroscopic visualization of the patient, including, but not limited to, surgical orthopedic procedures and critical and emergency care procedures.

    FDA Recall
    Terminated ·Orthoscan, Inc.·Product code OXO·August 31, 2017

    Mobile Mini C-arm system Part # 1000-0004-FD. Intended to provide the physician with general fluoroscopic visualization of the patient, including, but not limited to, surgical orthopedic procedures and critical and emergency care procedures.

    FDA Recall
    Terminated ·Orthoscan, Inc.·Product code OXO·August 31, 2017

    Mobile Mini C-arm system Part # 1000-0004. Intended to provide the physician with general fluoroscopic visualization of the patient, including, but not limited to, surgical orthopedic procedures and critical and emergency care procedures.

    FDA Recall
    Terminated ·Orthoscan, Inc.·Product code OXO·August 31, 2017

    Mobile Mini C-arm system Part # 1000-0001. Intended to provide the physician with general fluoroscopic visualization of the patient, including, but not limited to, surgical orthopedic procedures and critical and emergency care procedures.

    FDA Enforcement
    Class II ·Terminated·Orthoscan, Inc.·January 17, 2018

    Ziehm Vision RFD 3D. Interventinoal fluoroscopic x-ray system

    FDA Recall
    Open, Classified ·Orthoscan, Inc.·Product code OWB·August 8, 2024

    Ziehm Solo. Digital Mobile C-arm

    FDA Recall
    Open, Classified ·Orthoscan, Inc.·Product code OWB·August 8, 2024

    Ziehm Solo FD. Interventional fluoroscopic x-ray system

    FDA Recall
    Open, Classified ·Orthoscan, Inc.·Product code OWB·August 8, 2024