99 results
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10ms
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Sources: EU EUDAMED, US FDA
iLED 7 surgical lights, Model Numbers: a) 4068110 (Ceiling Single Surgical Light); b) 4068120 (Mobile Surgical Light); c) 4068140 (Pendant Surgical Light); d) 4068210 (Ceiling Duo Surgical Lights); e) 4068310 (Ceiling Trio Surgical Lights); f) 4068410 (Ceiling Quad Surgical Lights)
FDA Enforcement
Class II
·Ongoing·Baxter Healthcare Corporation·July 17, 2024
VidiaPort carrying arm, mount for auxiliary products, model numbers: a) 4028110 (Ceiling Single Surgical Light); b) 4028210 (Ceiling Duo Surgical Lights); c) 4028310 (Ceiling Trio Surgical Lights)
FDA Enforcement
Class II
·Ongoing·Baxter Healthcare Corporation·July 17, 2024
System Material # Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee multi-purpose 10094139 Artis zee biplane 10094141 Artis zeego 10280959 Artis Q floor 10848280 Artis Q ceiling 10848281 Artis Q biplane 10848282 Artis Q.zeego 10848283 Artis Q.zen floor 10848353 Artis Q.zen ceiling 10848354 Artis Q.zen biplane 10848355 Fluoroscopic X-Ray System
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·February 8, 2023
ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ARTIS icono ceiling Model 11328100. ARTIS icono floor Model 11327700. interventional fluoroscopic x-ray system
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·June 10, 2026
Siemens Artis Models: Interventional Fluoroscopic X-Ray Systems-Models: Artis zee floor- 10094135 Artis zee ceiling- 10094137 Artis zee multi-purpose- 10094139 Artis zee biplane- 10094141 Artis zeego- 10280959 Artis Q floor- 10848280 Artis Q ceiling- 10848281 Artis Q biplane- 10848282 Artis Q zeego- 10848283 Artis Q.zen floor- 10848353 Artis Q.zen ceiling- 10848354 Artis Q.zen biplane- 10848355 Artis zee floor MN- 10094142 Artis zee biplane MN- 10094143
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·April 24, 2024
Artis zee ceiling, Model Number 10094137
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022
Artis Q.zen ceiling, Model Number 10848354
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022
Artis Q ceiling, Model Number 10848281
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022
Artis Q floor- Model No. 10848280 Artis Q ceiling- Model No. 10848281 Artis Q biplane- Model No. 10848282 Artis Q zeego- Model No. 10848283 Artis Q.zen floor- Model No. 10848353 Artis Q.zen ceiling- Model No. 10848354 Artis Q.zen biplane- Model No. 10848355
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·September 7, 2022
Alphenix INFX-8000H, interventional fluoroscopic x-ray system
FDA Enforcement
Class II
·Ongoing·Canon Medical System, USA, INC.·February 4, 2026
Artis zee/ zeego & Artis Q/ Q.zen Artis Pheno
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·January 20, 2021
Artis zee ceiling-interventional Fluoroscopic X-Ray System Model Number: 10094137
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·May 5, 2021
ARTIS icono (ceiling configuration), Fluoroscopic x-ray system; Model no. 11328100
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·December 20, 2023
Philips Azurion 7M20 systems with FlexArm ceiling-mounted system. Model Number: 722234;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·December 3, 2025
Alphenix INFX-8000F, interventional fluoroscopic x-ray system
FDA Enforcement
Class II
·Ongoing·Canon Medical System, USA, INC.·February 4, 2026
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728333 - Spectral CT:
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·July 7, 2021
ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700.
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·April 15, 2026
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882446 - Vereos PET/CT
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·July 7, 2021
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882442/882456 - Ingenuity TF PET/CT
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·July 7, 2021
Bransist Safire, Digital Angiography System containing a MS-200 Ceiling Suspended C-arm Support - Product Usage: designed to provide fluoroscopic images of the patient during diagnostic surgical and interventional angiography and cardiology procedures.
FDA Enforcement
Class II
·Ongoing·Shimadzu Medical Systems·December 16, 2020