12 results
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8ms
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Sources: EU EUDAMED, US FDA
MAVIG Portegra or Portegra2 Overhead Counterpoise System (OCS) used in conjunction with the Medrad Stellant CT Injection System (Certegra Workstation), Medrad Mark 7 Arterion" Injection System, or Medrad Mark V ProVis Injection System, Catalog Numbers: Catalog numbers: OCS CEIL (58-S, 58-P, 85-S, 85-P, 100-S, 100-P, 70Si, 97Si), OCS TRACK (58-S, 58-P, 80-S, 80-P), OCS WALL (S, P), OCS (115A, 115CT, 125CT, 125A, 135A, 135CT, 145, 155A, 165A, 115AS, 115CTS), EOC (700, 700S), EOW 700, EOA 700
FDA Enforcement
Class II
·Terminated·Bayer Medical Care, Inc.·January 23, 2019
Medtronic Implantable Insulin Pump System, REF: MMT-2007D, Sterile EO, CE 0459 UDI: 00763000043001
FDA Enforcement
Class II
·Terminated·Medtronic Inc.·June 10, 2020
REF 7812400, Replacement Connector For 4F Groshong NXT clearVue PICC with Extension Leg, Rx Only, Sterile EO, CE 2797, UDI: (01)10801741075268 - Product Usage: is designed for use when central venous catheterization is prescribed.
FDA Enforcement
Class II
·Terminated·Bard Access Systems Inc.·May 26, 2021
Perfusion Pack, Rx only, Sterile EO
FDA Enforcement
Class II
·Terminated·LivaNova USA·January 30, 2019
Cobra x5 1-Ch EMG ET Tube, 7.0mm, REF LTE700M-5, Rx Only, Sterile EO CE UDI: B006LTE700M52/$$7061418C - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature as well as providing an open airway for patient ventilation during surgical or parasurgical care using any compatible nerve monitoring system.
FDA Enforcement
Class II
·Terminated·Neurovision Medical Products Inc·September 2, 2020
steroEOS Workstation with software versions: 1.3, 1.4 and 1.5 used in processing 3D X-ray images Product Usage: The sterEOS Workstation is a general system for acceptance , transfer, display and digital processing of two 3D x-ray images.
FDA Enforcement
Class II
·Terminated·EOS Imaging·January 1, 2014
ROTH MOBELI Grab Handles used with EOS System: MOBELI Stabi Vario Grab Handle, ROTH Catalogue Number 14002 96 S, EOS Imaging Catalogue Number 9000111773; and MOBELI Dual Grip Grab Handle, ROTH Catalogue Number 14002 25 S, EOS Imaging Catalogue Number 9000111774.
FDA Enforcement
Class II
·Terminated·EOS Imaging·July 5, 2017
EOS System X- ray beam Digital radiography system used in general radiographic examinations.
FDA Enforcement
Class II
·Terminated·EOS Imaging·January 15, 2014
sterEOS workstation
FDA Enforcement
Class II
·Terminated·EOS Imaging·September 26, 2018
The EOSedge system may acquire two simultaneous orthogonal planar images for a standing or seated patient at low dose. The scan length is defined by the user and may cover the whole body or a specific area (spine, lower limbs, etc.). EOSedge consists of a gantry and an acquisition workstation. ¿ The gantry contains two orthogonal acquisition units, each of which comprises an X-ray source (high frequency generator + X-ray tube + collimator) and an X-ray detection system (detector + electronics). ¿ The acquisition workstation and its software control the generators and detectors. It is also used to enter patient data, via RIS/HIS or manually, to define acquisition parameters, process images and record images in DICOM 3.0 format. The intended use/indications for use, technological characteristics, and principles of operation of the EOSedge system are described below.
FDA Enforcement
Class II
·Terminated·EOS Imaging·April 21, 2021
EOS X-ray Medical Diagnostic , X-ray Equipment System Digital Radiography used in general radiographic examination.
FDA Enforcement
Class II
·Terminated·Eos Imaging Inc·October 10, 2012
EOS, Digital radiography system used in general radiographic examinations.
FDA Enforcement
Class II
·Terminated·Eos Imaging Inc·May 13, 2015