6 results
·
13ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Completed
×
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
Ceiling Mounted Surgical Light System TruLight 3000/5000 and Ceiling Mounted Surgical Light System iLED3/iLED5
FDA Enforcement
Class II
·Completed·Trumpf Medical Systems, Inc.·January 6, 2016
ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model 10849000
FDA Enforcement
Class II
·Completed·Siemens Medical Solutions USA, Inc·July 4, 2018
MIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical surgical system, Catalog Number MIRA-CAP-110, Software Version 4.0.3
FDA Enforcement
Class II
·Completed·VIRTUAL INCISION CORPORATION·June 11, 2025
EPIQ Ultrasound Systems, Model: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPIQ CVx, EPIQ CVxi
FDA Enforcement
Class II
·Completed·Philips Ultrasound Inc·August 25, 2021
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