6 results
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14ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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A-Series BiPAP A 40, A-Series BiPAP A30 Continuous Ventilator, Non-life Supporting
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
BiPAP A40 Ventilators: BiPAP A40, Part Numbers 1111169 (US and OUS) and (OUS ONLY)1111170 1111171 1111173 1111174 1111175 1111177 1116156 1111170S BR1111169 CN1111169 IT1111169 R1111169 R1111177 R1116156 ; BiPAP A40 Pro, Part Numbers (OUS Only): ARX3100S19 AUX3100S19 BLX3100S19 BRX3100S18 CAX3100S12 CAX3100T12 DEX3100S13 EEX3100S19 ESX3100S19 FRX3100S14 GBX3100H19 GBX3100S19 IAX3100S19 INX3100H19 INX3100S19 ITX3100S21 SPX3100S19 ; BiPAP A40 EFL, Part Numbers (OUS Only): AUX3000S19 DEX2900S13 DEX3000S13 EEX3000S19 ESX3000S19 FRX3000S14 GBX3000S19 INX3000H19 ITX3000S21
FDA Enforcement
Class I
·Ongoing·Philips Respironics, Inc.·May 29, 2024
Philips BiPAP A40, 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
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