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    Access BR Monitor, Part No. 387620

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code MOI·April 13, 2017

    ExacTrac Dynamic software, Model 20910-01B ETD Positioning and Monitoring Installer 1.0.2 - Product Usage: intended to position patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, to monitor the patient position, and to provide a beam hold signal in case of a deviations in order to treat lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.

    FDA Recall
    Terminated ·Brainlab AG Olof-palme-str. 9 Munich Germany·Product code IYE·May 14, 2021

    Elastic Traction Device, 11mm Lower. UPN: ER56041 Reference Number: ETD-D-26-235-C-N - Product Usage: indicated for use in flexible Endoscopy to provide retraction to assist in tissue resection, exposure, and removal of tissue within the gastrointestinal tract.

    FDA Recall
    Terminated ·Micro-Tech Usa·Product code MND·October 5, 2020

    PARPARELLA-TYPE VENT TUBE, 1.02 MM, SILICONE, REF 240044, QTY 6, Rx Only, STERILE EO, GYRUS ACMI INC., Tympanostomy tube

    FDA Recall
    Terminated ·Gyrus Acmi, Incorporated·Product code ETD·October 17, 2012

    Armstrong Grommet with wire Otological Ventilation Tube Catalog #: VT-0507-01, Sterilized by Ethylene Oxide, Rx Only. Intended to provide ventilation to the middle ear space through the tympanic membrane.

    FDA Recall
    Terminated ·Summit Medical, Inc.·Product code ETD·May 12, 2014

    MICRON BOBBIN VENT TUBE, 1.27 MM I.D., TITANIUM, REF 145281-ENT, QTY 1, STERILE EO, GYRUS ACMI INC., 136 TURNPIKE ROAD, SOUTHBOROUGH, MA 01772 USA. Intended to be implanted for ventilation or drainage of the middle ear.

    FDA Recall
    Terminated ·Gyrus ACMI Corporation·Product code ETD·January 8, 2010

    VT-0101-50 Otological Ventilation Tubes, Catalog Number VT-0101-50, Donaldson, with tab, 1.14 mm Lumen, Silicone, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc., St Paul, MN 55121-1385 USA. VT-0204-01 Otological Ventilation Tubes, Catalog Number VT-0204-01, Shepard, 1.0 mm Lumen, Fluoroplastic, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc., St Paul, MN 55121-1385 USA. VT-0406-01 Otological Ventilation Tubes, Catalog Number VT-0406-01, T-Tube, 5mm x 4mm x 1.14mm Lumen, SI, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc., St Paul, MN 55121-1385 USA. VT-0503-01 Otological Ventilation Tubes, Catalog Number VT-0503-01, Armstrong Grommet, 1.14mm Lumen, Fluoroplastic, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc., St Paul, MN 55121-1385 USA. VT-0503-50 Otological Ventilation Tubes, Catalog Number VT-0503-50, Armstrong Grommet, 1.14mm Lumen, Fluoroplastic, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc., St Paul, MN 55121-1385 USA. VT-0507-01 Otological Ventilation Tubes, Catalog Number VT-0507-01, Armstrong Grommet w/wire, 1.14mm Lumen, FL, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc., St Paul, MN 55121-1385 USA. VT0508-50 Otological Ventilation Tubes, Catalog Number VT-0508-50, Modified Armstrong Grommet 1.14mm Lumen, Fluoroplastic, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc., St Paul, MN 55121-1385 USA. VT-1002-50 Otological Ventilation Tubes, Catalog Number VT-1002-50, Collar Button, 1.27mm Lumen, Silicone, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc., St Paul, MN 55121-1385 USA. VT-1035-01 Otological Ventilation Tubes, Catalog Number VT-1035-01, Collar Button, 1.5mm Lumen, Titanium, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc., St Paul, MN 55121-1385 USA. VT1204-01 Otological Ventilation Tubes, Catalog Number VT-1204-01, Reuter Bobbin 1.14mm , Lumen, FL Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc., St Paul, MN 55121-1385 USA. VT-1421-01 Otological Ventilation Tubes, Catalog Number VT-1421-01, Angled Tab Bobbin 1.27mm Lumen, TI, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc., St Paul, MN 55121-1385 USA. ET-ABGDT-45 Distributed By API Anthony products, Inc., ET-ABGDT-45 Armstrong Grommet, 1.14mm Lumen, FP Sterilized by Ethylene Oxide, Rx Only, Micromedics, St Paul, MN 55121-1385 USA, Otological Ventilation Tubes. ET-GTST-45-12, Distributed By API Anthony products, Inc., ET-GTST-45-12, T-tube 12 x 10, 1.14mm Lumen, SI , Sterilized by Ethylene Oxide, Rx Only, Micromedics, St Paul, MN 55121-1385 USA, Otological Ventilation Tubes. ET-SPDT-40T, Distributed By API Anthony products, Inc., ET-SPDT-40T Shea Parasol w/Tab, 1.0mm Lumen, SI, Sterilized by Ethylene Oxide, Rx Only, Micromedics, St Paul, MN 55121-1385 USA, Otological Ventilation Tubes. ET-TBDT-45 Distributed By API Anthony products, Inc., ET-TBDT-45 Reuter Bobbin w/c Holes 1.14mm Lumen, FP, Sterilized by Ethylene Oxide, Rx Only, Micromedics, St Paul, MN 55121-1385 USA, Otological Ventilation Tubes.

    FDA Recall
    Terminated ·Micromedics, Inc.·Product code ETD·March 15, 2010

    OLA Buffer For Laboratory Use; Contents: 1 tube with buffered solution containing MgCl2 (80 M) and KCL (300 M. 10.0ml.) PN: 50003300; Store at d - 15C. Product Usage: General Purpose Reagent for laboratory use.

    FDA Recall
    Terminated ·Celera Corporation·Product code LDT·July 12, 2013

    There is a complaint regarding internal check cable guide mechanism failure for the Nucletron Flexitron brachytherapy afterloader system. Due to an obstruction during the check cable out drive, the internal guiding tube became displaced and the check cable became damaged. This issue could cause treatment interruption or in a very unlikely scenario, incorrect source positioning and radiation treatment errors.

    FDA Recall
    Terminated ·Nucletron BV Waardgelder 1 POBox 930 Veenendaal Netherlands·Product code JAQ·November 18, 2019

    Orthoralix 8500 DDE Panoramic Dental X-Ray System; Extraoral x-ray unit with timer; Gendex Dental Systems, Des Plaines, IL 60018; part number 110-0234G1 (domestic) and 110-0234G3 (international) The Orthoralix 8500 DDE Panoramic Dental X-Ray System is used as an extraoral source of x-rays for imaging of the dento-maxillofacial area.

    FDA Recall
    Terminated ·Gendex Dental Systems·Product code EHD·December 21, 2010

    Gendex Dental Systems, Gendex eXpert DC Intraoral X-Ray System; a dental x-ray system; Model 110-0205G1, catalog number EXPERTDC75NA

    FDA Recall
    Terminated ·Gendex Dental Systems·Product code EHD·December 17, 2010

    eXpertDC intraoral x-ray, models: eXpert DC, NA, 75 Inch reach; eXpert DC, NA, 65 Inch reach; eXpert DC, CN, 55 Inch reach; eXpert DC, WW, 75 Inch reach; eXpert DC, WW, 65 Inch reach; eXpert DC, WW, 55 Inch reach; OEM Arm Assembly w/o cables; Assy, Articulated Arm & Tubehead, eDC; and Assy, Articulated Arm & Tubehead, 765DC Product Usage: intraoral x-ray

    FDA Recall
    Terminated ·Gendex Corp·Product code EHD·August 12, 2014

    NOMAD Pro2 Packaged X-Ray System, Part Number 08500021; NOMAD Pro2 Packaged X-Ray System Black, Part Number 08500022; NOMAD Pro2 Vet Packaged X-Ray System, Part Number 08500023; NOMAD Pro2 Vet Packaged X-Ray System Black, Part Number 08500024; NOMAD Pro2 Packaged X-Ray System, GBL, Part Number 08500025 and Part Number 08500026; NOMAD Pro2 Packaged X-Ray System, GLB, Vet, Part Number 08500027 and Part Number 08500028; NOMAD Pro2 Package X-Ray System, GLB, Black, Part Number 08500029

    FDA Recall
    Terminated ·Aribex Inc·Product code EHD·July 18, 2016

    NOMAD Pro Packaged X-Ray System, Part Number 08500009; NOMAD Pro Vet Packaged X-Ray System, Part Number 08500011; NOMAD Pro Packaged X-Ray System - Europe, Part Number 08500013; NOMAD Pro X-Ray System, Remote Config., Part Number 08500017; NOMAD Pro Packaged X-Ray System JP, Part Number 08500019

    FDA Recall
    Terminated ·Aribex Inc·Product code EHD·July 18, 2016

    Panoramic X-ray Model PC-1000, Laser-1000 packed in a crate Product Usage: The PC-1000 will enable the user to take panoramic x-ray images. The PC-1000/Laser1000 will enable the user to take panoramic x-ray images as well as cephalometric x-ray images.

    FDA Recall
    Terminated ·Panoramic Rental Corp.·Product code EHD·August 19, 2016

    Orthoralix 9200 DDE Panoramic and Cephalometric Dental X-Ray System; Extraoral x-ray unit with timer; Gendex Dental Systems, Des Plaines, IL 60018; Part numbers 110-0199G2, 110-0199G4, 110-0234G1 and 110-0234G3. The intended use of the device is to be used as an extraoral source of x-rays for imaging of the dento-maxillo-facial area.

    FDA Recall
    Terminated ·Gendex Dental Systems·Product code EHD·February 4, 2011

    Panoramic X-ray Model PC-1000 The PC-1000 will enable the user to take panoramic x-ray images. The PC-1000/Laser 1000 will enable the user to take panoramic x-ray images as well as cephalometric x-ray images.

    FDA Recall
    Terminated ·Panoramic Rental Corp.·Product code EHD·June 4, 2015

    Clea Stand Ceiling used with the Integris X-Ray System H5000, Allura 12/15, Allura 9C

    FDA Recall
    Terminated ·Philips Medical Systems Sales & Service Region No. America·Product code EHD·October 10, 2003

    NanoTips 30g 20pk, 100pk PN 1240, 1426 Description: NanoTips are injection molded royal blue tips that contain stainless steel 30-gauge cannula to aid in the delivery of chemicals. The NanoTip base is made from a polypropylene copolymer. The stainless steel cannula is made from 304 SS, and is 30-gauge in diameter and 0.488 in length. The cannula is secured in the base with an epoxy adhesive. Indications: Tips, when used in conjunction with the range of available syringes and products, provide a technique that is designed to provide a faster, easier, and more precise delivery. They are designed and created in such a way to generate less product waste and provide optimum control/leverage. Tips are also used for moisture removal and for directing laser light beam. Each of the tips is part of delivery systems designed for dentist-supervised, intra-oral procedures. The NanoTIp is designed for use with dental products manufactured by Ultradent Products, Inc. such as: UltraSeal XT plus, UltraSeal XT hydro, Ultra-Etch, PermaFloIdeal for microscopic restorative dentistry

    FDA Recall
    Terminated ·Ultradent Products, Inc.·Product code EID·December 14, 2016

    The FOCUS is a microprocessor controlled intra-oral x-ray unit with a Load Matching Frequency (LMF) DC generator, which produces dental images on digital and film media. For the digital images the FOCUS is connected to the Sigma USB terminal which is connected to a PC, which reads the image data from a sensor and displays the image on the PC monitor. In order to make installation and service faster and easier the electronics is integrated into the horizontal arm. FOCUS is intended to be used for producing diagnostic x-ray radiographs of dentition, jaws and other oral structures.

    FDA Recall
    Terminated ·Instrumentarium Dental, PaloDEx Group Oy Nahkelantie 160 Tuusula Finland·Product code EHD·January 14, 2014