9 results
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27ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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BiPAP V30 Auto Ventilator, Part Number 1111178
FDA Enforcement
Class I
·Ongoing·Philips Respironics, Inc.·May 29, 2024
BiPAP V30 Auto, US market: Continuous ventilator, non-life-supporting. Material Number: 1111178
FDA Enforcement
Class II
·Terminated·Philips Respironics, Inc.·June 2, 2021
A-Series BiPAP Hybrid A30 (not marketed in US), A-Series BiPAP V30 Auto Continuous Ventilator, Minimum Ventilatory Support, Facility Use
FDA Enforcement
Class I
·Ongoing·Philips Respironics, Inc.·July 21, 2021
Philips BiPAP A30, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.
FDA Enforcement
Class I
·Ongoing·Philips Respironics, Inc.·September 14, 2022
Philips BiPAP V30 Auto, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.
FDA Enforcement
Class I
·Ongoing·Philips Respironics, Inc.·September 14, 2022
dS Breast 16ch 3.0T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 4, 2024
BiPAP V30 Auto Ventilator. Intended to provide non-invasive ventilatory support for pediatric and adult patients weighing over 10 kg.
FDA Enforcement
Class I
·Ongoing·Philips Respironics, Inc.·July 9, 2025
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021