6 results
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9ms
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Sources: EU EUDAMED, US FDA
TIBIAL TRAY , SIZE 4, REF 90-SRK-200400, QTY: 1, STERILE R, Responsive Orthopedics, total knee replacement
FDA Enforcement
Class II
·Terminated·Medtronic Sofamor Danek USA Inc·August 31, 2016
Pilling Wecksorb Cylindrical Sponges
FDA Enforcement
Class II
·Ongoing·TELEFLEX LLC·January 4, 2023
Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Software Version#: THA 3.0 and later, PKA 3.0 and later, and TKA 1.0 - Product Usage: The MICS Handpiece is attached to the distal end of the robotic arm and is used to register the RIO (Mako robot) and to execute bone preparation during a Mako Total Knee or Mako Partial Knee procedure (PKA Software Application 3.0 or later).
FDA Enforcement
Class II
·Completed·Mako Surgical Corporation·November 25, 2020
Sedecal Soltus Battery Mobile X-Ray System REF Soltus 450 Battery Mobile X-Ray System REF Soltus 500
FDA Enforcement
Class II
·Ongoing·SEDECAL SA·November 16, 2022
GE Healthcare Revolution CT, System, X-ray, Tomography, Computed
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·March 19, 2025
Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.
FDA Enforcement
Class II
·Terminated·Bayer Corp·June 11, 2014