BEUDAMED
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    SURGICAL PLANNING ASSOCIATES

    FDA registration
    SURGICAL PLANNING ASSOCIATES·2 products·🇺🇸 United States

    ShapeMatch Cutting Guides Product Usage: The ShapeMatch Cutting Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total knee arthroplasty components intraoperatively and in guiding the marking of bone before cutting.

    FDA Enforcement
    Class I ·Terminated·Stryker Howmedica Osteonics Corp.·April 24, 2013

    StealthStation S8 Application version 2.0 and 2.0.1 (Part 9735762) The StealthStation System, with StealthStation Cranial software, is intended as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures. The StealthStation FlexENT System, with StealthStation ENT software, is intended as an aid for locating anatomical structures in either open or percutaneous ENT procedures.

    FDA Enforcement
    Class I ·Ongoing·Medtronic Navigation, Inc.·November 15, 2023

    ENDOTAK DSP

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·October 6, 2011

    DA VINCI SURGICAL SYSTEM

    FDA Adverse Event
    Other ·INTUITIVE SURGICAL, INC.·Product code NAY·June 28, 2007

    DA VINCI S SURGICAL SYSTEM

    FDA Adverse Event
    Other ·INTUITIVE SURGICAL, INC.·Product code NAY·August 16, 2007

    EXCLUDER BIFURCATED ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES,INC·Product code MIH·September 24, 2004

    EXCLUDER BIFURCATED ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES, INC.·Product code MIH·July 22, 2004

    EXCLUDER BIFURCATED ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES, INC.·Product code MIH·October 13, 2004

    DA VINCI S SURGICAL SYSTEM

    FDA Adverse Event
    Other ·INTUITIVE SURGICAL, INC.·Product code KOG·November 17, 2006

    DA VINCI SURGICAL SYSTEM

    FDA Adverse Event
    Other ·INTUITIVE SURGICAL, INC.·Product code GEI·November 10, 2006

    DA VINCI S SURGICAL SYSTEM

    FDA Adverse Event
    Other ·Product code NAY·October 4, 2007

    DA VINCI SURGICAL SYSTEM

    FDA Adverse Event
    Other ·INTUITIVE SURGICAL, INC.·Product code KOG·June 29, 2006

    ILUMAVision Software, version 2.1.0 Picture Archiving and Communication system Product used as a tool for the pre-surgical planning of the placement of dental implants and pre-surgical fabrication of stents to aid in dental implant insertion. In addition, it is used for diagnostics and treatment planning in orthodontic, ENT and similar applications.

    FDA Recall
    Terminated ·IMTEC IMAGING L.L.C.·Product code LLZ·August 3, 2009

    DA VINCI S SURIGICAL SYSTEM

    FDA Adverse Event
    Other ·INTUITIVE SURGICAL, INC.·Product code KOG·October 27, 2006

    ENDOWRIST

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC·Product code NAY·November 26, 2024

    ENDOWRIST

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC·Product code NAY·May 22, 2023

    ENDOWRIST

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC·Product code NAY·April 24, 2026

    DA VINCI S SURGICAL SYSTEM

    FDA Adverse Event
    Other ·INTUITIVE SURGICAL, INC.·Product code NAY·May 18, 2007

    DA VINCI SURGICAL SYSTEM

    FDA Adverse Event
    Other ·INTUITIVE SURGICAL, INC.·Product code KOG·January 12, 2007