12 results
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9ms
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Sources: EU EUDAMED, US FDA
Universal Robot UR5 arm, PV010204 subcomponent of Aesculap Aeos Digital Microscope System, PV010
FDA Enforcement
Class II
·Completed·Aesculap Implant Systems LLC·July 27, 2022
Aeos¿ Robotic Digital Microscope with software versions 2.7 or earlier Article Number: PV010
FDA Enforcement
Class II
·Terminated·Aesculap Implant Systems LLC·August 17, 2022
Aeos Robotic Digital Microscope, Product Code: PV010
FDA Enforcement
Class II
·Ongoing·Aesculap Inc·June 19, 2024
Boston Scientific, NovaGold High Performance Guidewire, Rx only, Sterilized using ethylene oxide, UPN M00552010 and M00552000, Manufactured by NeoMetrics Inc, 2605 Fernbrook Lane Suite J, Plymouth, MN 55447. The NovaGold Guidewire is intended for use in selective cannulation of the biliary ducts including the common bile, pancreatic, cystic, right and left hepatic ducts, and to aid in the placement of diagnostic and therapeutic devices during endoscopic procedures.
FDA Enforcement
Class II
·Terminated·NEO METRICS, INC.·June 18, 2014
ACCEL ELISA COVID-19 for the detection of total antibodies to SARS-CoV-2 Catalog AE301U Kit lots: PXCOV073020, PXCOV081220 Expiration dates: January 18, 2021 and January 26, 2021
FDA Enforcement
Class II
·Terminated·VEO DIAGNOSTICS, LLC·December 9, 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