13 results
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19ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710006412
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·June 12, 2024
Syngo.via and Syngo.x ; a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·June 10, 2015
Syngo.via picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·September 28, 2016
Syngo.x picture archiving and communication system Syngo.x is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·September 28, 2016
Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410. Model Number: WA91307C. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utilizes monopolar and bipolar high frequency current and supports ultrasonic instruments during open surgery, laparoscopic surgery, including single-site surgery, and endoscopic surgery.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·August 27, 2025
1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
Model Number L211 PROPONENT DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
VISIONIST CRT-P pacemaker, Models: a) U225 b) U226 c) U228
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·July 14, 2021
Hemodialysis Delivery System, Software Version 2.x.
FDA Enforcement
Class II
·Ongoing·Baxter Healthcare Corporation·November 17, 2021
BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators are anesthesia gas machine. In most cases, the customer ordered both a BleaseFocus anesthesia workstation and a 700/900 ventilator. In some cases, the customer may order a 700/900 stand-alone ventilator would could be used with a BleaseFocus anesthesia workstation at a later date.
FDA Enforcement
Class II
·Terminated·Del Mar Reynolds Medical, Ltd.·December 26, 2012