BEUDAMED
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    ACS HI-TORQUE EXTRA S'PORT(TM) GUIDE WIRE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Firefly

    FDA UDI
    INTUITIVE SURGICAL, INC.·00886874112779·FLUORESCENCE IMAGING PROCEDURE KIT

    Sierra

    FDA UDI
    Seaspine Orthopedics Corporation·10889981094676·Rod Pusher

    Elite®

    FDA UDI
    Ortho Organizers, Inc.·00190707052379·.022 SAA L7L -12T MINI TUBE

    WHS-1000 WOUND HEALING SYSTEM

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

    Ranfac Fat Aspiration Transfer Syringe (FATS) Procedure Pack, Ranfac Fat Aspiration Transfer Syringe (FATS) Containment Vessel

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

    Fluorescence Imaging Procedure Kits used with the da Vinci Si and Xi Surgical Systems; Model numbers: 950156-01, 950156-02, 950156-03. Product Usage: General and plastic surgery: The da Vinci Firefly Imaging system is intended to provide real-time endoscopic visible and near-infrared fluorescence imaging.

    FDA Recall
    Terminated ·Intuitive Surgical, Inc.·Product code NAY·September 9, 2015

    Fluorescence Imaging Procedure Kits used with the da Vinci Si and Xi Surgical Systems; Model numbers: 950156-01, 950156-02, 950156-03. Product Usage: General and plastic surgery: The da Vinci Firefly Imaging system is intended to provide real-time endoscopic visible and near-infrared fluorescence imaging.

    FDA Enforcement
    Class II ·Terminated·Intuitive Surgical, Inc.·September 23, 2015

    GRANUFLO

    FDA Adverse Event
    Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·June 27, 2014

    RIATA ST ACTIVE FIXATION

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·February 8, 2013

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·January 6, 2011

    Fluorescence Imaging Procedure Kit, designed for use with Firefly Fluorescence Imaging for the da Vinci Xi 4000 Surgical Systems. The Intuitive Surgical Endoscopic Instrument Control System (Intuitive Surgical da Vinci Surgical System Model IS3000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.

    FDA Enforcement
    Class II ·Terminated·Intuitive Surgical, Inc.·December 31, 2014

    Fluorescence Imaging Procedure Kit, designed for use with Firefly Fluorescence Imaging for the da Vinci Si 3000 Surgical Systems. The Intuitive Surgical Endoscopic Instrument Control System (Intuitive Surgical da Vinci Surgical System Model IS3000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.

    FDA Enforcement
    Class II ·Terminated·Intuitive Surgical, Inc.·December 31, 2014

    IntelliSpace Portal (ISP) DX/HX/EX, IntelliSpace Portal (ISP) IX, and IntelliSpace Portal (ISP) LX SPECT IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. IntelliSpace Portal (ISP) is a medical software system that allows multiple users to remotely access IntelliSpace Workspace Portal (ISP) from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·August 20, 2014