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    DIGIMATCH ORTHODOC ROBODOC ENCORE SURGICAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    Oticon

    FDA UDI
    Oticon A/S·05707131268679·ALTA PRO, DESIGNRITE 10 WL TC

    GEN4 INTERACTIVE

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828149013·GEN4 INTERACTIVE

    GEN4 INTERACTIVE

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828159135·GEN4 INTERACTIVE

    Easytech Anatomical Shoulder System

    FDA UDI
    FX SOLUTIONS·03701037301487·EASYTECH ANCHOR BASE TA6V Ø38 mm CEMENTLESS Ti/HA

    GEN4 INTERACTIVE

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828161275·GEN4 INTERACTIVE

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319704431·Kelly Hemostatic Forceps 5-1/2" (13.8cm), curved

    HEMOSTAT ROCHESTER-PEAN 6 1/4 STRAIGHT

    FDA UDI
    W.H. Holden, Inc.·D9281400380·

    HEMOSTAT ROCHESTER-PEAN 6 1/4 CURVED

    FDA UDI
    W.H. Holden, Inc.·D92814003810·

    CONTOUR CURVED CUTTER STAPLER CS

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code GDW·June 13, 2006

    DISPOSABLE REFLECTIVE MARKER SPHERES

    FDA 510(k)
    FDA Class 2 ·Neurology

    CURVED CUTTER STAPLER, MODELS CS40B, CS40G; RELOAD FOR CURVED STAPLER, MODELS CR40B, CR40G

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    FLEXTEND

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code DTB·October 3, 2014

    ONE TOUCH LANCING DEVICE

    FDA Adverse Event
    Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 31, 2013

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·June 25, 2011

    UNID ROD

    FDA Adverse Event
    Malfunction ·MEDICREA INTERNATIONAL SA·Product code MNI·July 29, 2024

    UNID ROD

    FDA Adverse Event
    Malfunction ·MEDICREA INTERNATIONAL SA·Product code MNI·July 29, 2024

    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