BEUDAMED
    10,000 results · 100ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    GE OEC Medical Systems, Inc.

    Manufacturer
    🇺🇸 United States

    GE OEC MEDICAL SYSTEMS, INC

    FDA registration
    GE OEC MEDICAL SYSTEMS, INC·4 products·🇺🇸 United States

    InstaTrak¿ 3500 Plus, ENTrakTM Plus, InstaTrak¿ 3500, ENTrakTM Computer-Assisted Navigation Systems (USA),

    FDA Enforcement
    Class II ·Terminated·GE OEC Medical Systems, Inc·December 25, 2013

    GE OEC 9900 Elite Fluoroscopy System with Integrated Navigation,GE OEC Medical Systems Inc.

    FDA Recall
    Terminated ·GE OEC Medical Systems, Inc·Product code JAA·September 13, 2006

    GE OEC 9800 Fluoro C-Arm X-ray System, GE OEC Medical Systems Inc.

    FDA Recall
    Terminated ·GE OEC Medical Systems, Inc·Product code JAA·August 16, 2006

    GE OEC 9900 Elite Digital Mobile C-Arm X-ray system, GE OEC Medical Systems Inc.

    FDA Recall
    Terminated ·GE OEC Medical Systems, Inc·Product code JAA·August 16, 2006

    OEC 9900 Elite Fluoroscopy System, Catalog No. 887208 and 887210, GE OEC Medical Systems, Inc.

    FDA Recall
    Terminated ·GE OEC Medical Systems, Inc·Product code JAA·September 30, 2006

    InstaTrak 3500 Plus, ENTrakTM Plus, InstaTrak 3500, ENTrakTM Computer-Assisted Navigation Systems (USA),

    FDA Recall
    Terminated ·GE OEC Medical Systems, Inc·Product code LLZ·November 26, 2013

    Transmitter Sensor Cables, Part Numbers: 1002008, 1004587, 1007914-NAV, GE Healthcare Surgery, Salt Lake City, UT 84116. Cables are used with InstraTrak Navigation Systems, Models IT3000, IT2500, IT2500+, IT3500, IT3500+. InstaTrak System is intended as an aid to the surgeon for precisely locating anatomical structures anywhere on the human body during either open or percutaneous procedures. It is indicated for any medical condition that may benefit from the use of stereotactic surgery and which provides a reference to rigid anatomical structures such as sinus, skull, long bone, or vertebra, visible on medical images such as CT, MR, or X-ray.

    FDA Recall
    Terminated ·GE OEC Medical Systems, Inc·Product code LLZ·February 24, 2011

    Receiver Sensor Cables, Part Numbers: 1001989, 1001990, 1004069, 1007907-NAV, GE Healthcare Surgery, Salt Lake City, UT 84116. Cables are used with InstraTrak Navigation Systems, Models IT3000, IT2500, IT2500+, IT3500, IT3500+. InstaTrak System is intended as an aid to the surgeon for precisely locating anatomical structures anywhere on the human body during either open or percutaneous procedures. It is indicated for any medical condition that may benefit from the use of stereotactic surgery and which provides a reference to rigid anatomical structures such as sinus, skull, long bone, or vertebra, visible on medical images such as CT, MR, or X-ray.

    FDA Recall
    Terminated ·GE OEC Medical Systems, Inc·Product code LLZ·February 24, 2011

    GE Medical Systems SCS

    Authorized representative
    🇫🇷 France·27 Manufacturers·564 Devices

    GE OEC, InstaTrak 3500 Plus FluoroTrak and Fluoro CAT Spinal Applications used with Regular and Super 9800 and 9600 Arm Systems. GE Health Medical Systems, Inc, Salt Lake City, UT 84116-2862

    FDA Recall
    Terminated ·GE OEC Medical Systems, Inc·Product code LLZ·March 23, 2007

    GE Medical Systems, OEC, Vascular Drape, 00-902776-01, Sterile. 150" long x 87" wide. Distributed by GE OEC Medical Systems, Salt Lake City, UT 84116 USA.

    FDA Recall
    Terminated ·GE Medical Systems, LLC·Product code MMP·August 15, 2008

    GE Healthcare, Drapes and Sterile Covers PART NUMBER DESCRIPTION 00-900352-01 DRAIN BAG W/HOSE (2000/2500) 2.0 PE MATERIAL 00-900352-01-OEC STRL, BAG, DRAIN WITH PLASTIC CLIPS AND HOSE 2000,2500 00-900352-02 STRL, BAG, DRAIN WITH METAL TABS 00-900493-03 COVER DISPOSABLE X-RAY TUBE 00-900605-01 UROFAST DRAIN BAG (UROFAST ONLY) 00-900605-01-OEC STRL, BAG, DRAIN, WITH HOSE, UROFAST 00-900885-01 URO2600 DRAIN BAG 2.0 PE MATERIAL 00-900885-01-OEC STRL, BAG, DRAIN, URO2600 00-900943-01 STRL, COVER, CARM, HALF BAG, 36X80, 90,94,76 00-900974-01 STRL, DRAPING, MINI-CARM, KYBRD, BLK FTSW, 6600 00-901072-01 URO 2600 DISPOSABLES PACK 2.0 PE MATERIAL 00-901072-01-OEC STRL, PACK, DISPOSABLES, UROVIEW 2600 00-901169-01 12 TUBE DRAPE (36X36) 2.0 PE MATERIAL 00-901169-01-OEC STRL, COVER, DISPOSABLE, 12 INCH TUBE 9600 00-901268-01 DRAPE,STERIQUIK, STANDARD&SUPER- C,9600/7700 00-901390-01 STRL, DRAPING, KEYBOARD, FOOTSWITCH, 20PACK, 6600 00-901391-01 STRL, DRAPE, C-ARM ONLY, 6600 00-901392-01 STRL, COVER, KEYBOARD, 66,68 00-901501-01 9600/9800/SUPER C DISPOSABLES PACK 2.0 PE MATERIAL 00-901501-01-OEC STRL, PACK, DISPOSABLES, MODEL 9800, 20 PACK 00-901581-01-OEC STRL, COVER, DISPOSABLE, IR REMOTE, 9600, 9800 00901588-01 12 C ARM DISPOSABLES PACK 2.0 PE MATERIAL 00-901588-01-OEC STRL, PACK, DISPOSABLES, 12 INCH, 20 PACK SCD 9600 00-901761-01 STRL, DISPOSABLES PACK, UROVIEW 2800 00-901831-02 STRL, COVER, FLUOROTRAK MONITOR, DISPOSABLE BOX 10 PER PKG 00-901832-01 STRL, APIX, COVER, DISPOSABLE CONTROLPANEL COVERS, REPLACEMENT PART CASE OF 25 00-901917-01 STRL, DRAPE, C-ARM, 6800 00-901918-01 MINIVIEW 6800 C-ARM CONSUMABLES PACK GRAY FOOTSWITCH 00-901918-01-OEC STRL, DRAPE, 20 PACK, 6800 00-902752-01 STRL, RUI COVERS 25 COVERS 00-902753-01 STRL, PACK, DISPOSABLE, 9800MD, 9 INCH 20 PACKS 00-902754-01 STRL, PACK, DISPOSABLE, 9800MD, 12 INCH 20 PACKS 00-902776-01 STRL, DRAPE, VASCULAR 00-902864-01 STRL, DRAPE, HALF, C ARM, 9800 9600 00-902934-01 STRL, DRAPE, WORKSTATION, 20 PER BOX, 9900 1003135 STRL, BAG, FLAT PANEL E7009AE STRL, DRAPE, AFM/CFM PEDESTAL, 25 PER BOX E7009AF STRL, DRAPE, AFM/CFM JOYSTICK, 50 PER BOX E7009AG STRL, DRAPE, LARGE DOME BAG, 20 PER BOX E7009AH STRL, DRAPE, MEDIUM DOME BAG, 20 PER BOX E7009AJ STRL, DRAPE, SMALL DOME BAG, 20 PER BOX Sterile EO, Distributed by GE Medical Systems, Milwaukee, WI 53201, Manufactured by Contour Fabricators, Inc. Fenton, MI 48430. The disposable sterile product provide a sterile barrier between the imaging device and sterile surgical field.

    FDA Recall
    Terminated ·GE Medical Systems, LLC·Product code MMP·August 29, 2008

    OEC 9800MD Motorized C-arm System, Fluoroscopic X-ray System,

    FDA Recall
    Terminated ·GE OEC Medical Systems, Inc·Product code JAA·February 9, 2007

    OEC 9800 Fluoroscopic X-ray System, Model Number A349855, GE Healthcare, Surgery.

    FDA Recall
    Terminated ·GE OEC Medical Systems, Inc·Product code JAA·February 9, 2007

    ENTrak Plus Navigation and Visualization System

    FDA Recall
    Terminated ·GE OEC Medical Systems, Inc·Product code LLZ·July 12, 2004

    GEHC OEC 9900 ESP-15 Elite C-Arm fluoroscopic X-ray system, GE Healthcare, Salt Lake City, UT.

    FDA Recall
    Terminated ·GE OEC Medical Systems, Inc·Product code JAA·July 6, 2007

    GE OEC 6800 Fluoroscopic X-ray System, GE Healthcare, Salt Lake City, Utah.

    FDA Recall
    Terminated ·GE OEC Medical Systems, Inc·Product code JAA·June 12, 2007

    OEC 9900 Elite (NAV) Image-intensified fluoroscopic x-ray system, GE Healthcare, Salt Lake City, UT.

    FDA Recall
    Terminated ·GE OEC Medical Systems, Inc·Product code JAA·March 1, 2007