696 results · 7ms · Sources: EU EUDAMED, US FDA

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Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882476 - Gemini TF Big Bore 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 Bracket Assembly for use with CT and MX16 Models: 728131

FDA Enforcement
Class II ·Ongoing·Philips North America Llc·July 7, 2021

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 728333 - Spectral 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

Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems: Model - MX8000 Models: 728120/728125/728201

FDA Enforcement
Class II ·Ongoing·Philips North America Llc·July 7, 2021

Medfusion Model 3500 and 4000 Syringe Infusion Pumps and Medfusion 3010 and 3010A Syringe Infusion Pumps serviced during the same time period in which a main board was replaced using replacement main board part numbers G6000361, G6000435, G6001260, G6001560, G6001562 and G6002728.

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD Inc.·February 23, 2022

Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems. Brilliance 16 Power, Brilliance 16/10/6 Water/Air 728240/728245/728246 - Brilliance 16 728255/728256/728266 - Brilliance 6 728250/728251 - Brilliance 10 728260 - Extended Brilliance Workspace

FDA Enforcement
Class II ·Ongoing·Philips North America Llc·July 7, 2021

Hamilton-C6

FDA Enforcement
Class II ·Ongoing·Hamilton Medical AG·November 30, 2022

Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728332 - IQon Spectral CT : IQon Spectral CT

FDA Enforcement
Class II ·Ongoing·Philips North America Llc·July 7, 2021

Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems. BB (Big Bore) Oncology, BB (Big Bore) Radiology: 728242/728243/728244/728272 - Brilliance Big Bore

FDA Enforcement
Class II ·Ongoing·Philips North America Llc·July 7, 2021

Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems. Brilliance 64, Brilliance 40, Ingenuity Flex 728235 - Brilliance 40 728231/728232 - Brilliance 64 728317/728318 - Ingenuity Flex

FDA Enforcement
Class II ·Ongoing·Philips North America Llc·July 7, 2021

Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728306 - Brilliance iCT 728311 - Brilliance iCT SP

FDA Enforcement
Class II ·Ongoing·Philips North America Llc·July 7, 2021

Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Ingenuity Core, Ingenuity Core 128, Ingenuity CT 728321 - Ingenuity Core 728323 - Ingenuity Core 128 728326/728327 - Ingenuity CT

FDA Enforcement
Class II ·Ongoing·Philips North America Llc·July 7, 2021

Lazervida 10W diode laser cutter and engraver with Lazervida shield.

FDA Enforcement
Class II ·Ongoing·Flux Technology Inc.·June 11, 2025

RayStation/RayPlan. Model/Catalog Number: 10.1. Software Version: RayStation/RayPlan 10B. Radiation Therapy Treatment Planning System

FDA Enforcement
Class II ·Ongoing·RAYSEARCH LABORATORIES AB·January 28, 2026

Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 16.0.0 Software Version: RayStation 2024B Product Description: Radiation Therapy Treatment Planning System Component: No

FDA Enforcement
Class II ·Ongoing·RAYSEARCH LABORATORIES AB·January 28, 2026

Single Use Repositionable Clip QUICKCLIP PRO 165 CM 10/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202LR.A

FDA Enforcement
Class II ·Ongoing·Olympus Corporation of the Americas·June 28, 2023

Single Use Repositionable Clip QUICKCLIP PRO 165CM 5/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202LR.B

FDA Enforcement
Class II ·Ongoing·Olympus Corporation of the Americas·June 28, 2023

Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 10.1.1 Software Version: RayStation 10B SP1 Product Description: Radiation Therapy Treatment Planning System Component: No

FDA Enforcement
Class II ·Ongoing·RAYSEARCH LABORATORIES AB·January 28, 2026