15 results · 23ms · Sources: EU EUDAMED, US FDA

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Philips CT systems labeled as the following: 1. Brilliance iCT, Model Number: 728306.

FDA Enforcement
Class II ·Ongoing·Philips North America Llc·October 1, 2025

HA FlexTrak II-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710008732

FDA Enforcement
Class II ·Ongoing·Philips North America Llc·June 12, 2024

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

Altrua 2 pacemaker, Models: a) S701 b) S702 c) S722

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·July 14, 2021

INTUA CRT-P, Model Numbers: a) V272 b) V273 c) W273

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

Model Number U128, VALITUDE CRT-P EL MRI

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

Model Number L210 PROPONENT SR SL Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

Model Number S701 ALTRUA 2 SR SL Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

VALITUDE CRT-P pacemaker, Models: a) U125 b) U128

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·July 14, 2021

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

Proponent pacemaker, Models: a) L200 b) L201 c) L209 d) L210 e) L211 f) L221 g) L231

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·July 14, 2021

Model Number L121 ESSENTIO DR EL Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly

FDA Enforcement
Class II ·Ongoing·Covidien·August 28, 2024