85 results
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15ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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Trilogy Evo; Model No./Model Description -- AU2110X15B Trilogy Evo, Australia BL2110X15B Trilogy Evo, Benelux BR2110X18B Trilogy Evo, Brazil CA2110X12B Trilogy Evo, Canada DE2100X13B Trilogy Evo O2, Germany DE2110X13B Trilogy Evo, Germany DS2100X11B Trilogy Evo, O2, USA DS2110X11B Trilogy Evo, USA DS2110X11B Trilogy Evo, USA EE2100X15B Trilogy Evo O2, Eastern Europe EE2110X15B Trilogy Evo, Eastern Europe ES2100X15B Trilogy Evo O2, Iberia ES2110X15B Trilogy Evo, Iberia EU2100X15B Trilogy Evo, O2, EU EU2100X19 Trilogy Evo, O2, EU (Non-BT) EU2110X15B Trilogy Evo, EU EU2110X19 Trilogy Evo, EU (Non-BT) FR2100X14B Trilogy Evo O2, France FR2110X14B Trilogy Evo, France FX2100X15B Trilogy Evo, O2, INT GB2110X15B Trilogy Evo, Great Britain IA2100X15B Trilogy Evo O2, India IA2110X15B Trilogy Evo, India IN2100X15B Trilogy Evo, O2, International IN2100X19 Trilogy Evo, O2, International (Non-BT) IN2110X15B Trilogy Evo, International IT2100X21B Trilogy Evo O2, Italy IT2110X21B Trilogy Evo, Italy JP2100X16B Trilogy Evo, O2, Japan JP2110X16B Trilogy Evo, Japan KR2110X15B Trilogy Evo, Korea LA2100X15B Trilogy Evo, O2, Latin America LA2110X15B Trilogy Evo, Latin America LD2110X23B Garbin Evo, Linde ND2100X15B Trilogy Evo O2, Nordics ND2110X15B Trilogy Evo, Nordics RDS2110X11B Trilogy Evo, USA-Rental SP2100X26B LifeVentEVO2 TR2110X15B Trilogy Evo, Turkey UDS2110X11B Trilogy Evo, USA-RECERT VT2110X24B Aeris EVO
FDA Enforcement
Class I
·Ongoing·Philips Respironics, Inc.·September 11, 2024
Trilogy Evo EV300 -- Model Number/ Model Description: BL2200X15B Trilogy Evo, O2, Benelux EV300; BR2200X18B Trilogy Evo, O2, Brazil EV300; CA2200X12B Trilogy Evo, O2, Canada EV300; DE2200X13B Trilogy Evo, O2, Germany EV300; DS2200X11B Trilogy Evo, O2, USA EV300; DS2200X11B Trilogy Evo, O2, USA EV300; EE2200X15B Trilogy Evo, O2, Eastern Europe EV300; ES2200X15B Trilogy Evo, O2, Spain EV300; EU2200X15B Trilogy Evo, O2, EU EV300; FR2200X14B Trilogy Evo, O2, France EV300; FX2200X15B Trilogy Evo, O2, INT EV300; GB2200X15B Trilogy Evo, O2, Great Britain EV300; IN2200X15B Trilogy Evo, O2, INTL EV300; IT2200X21B Trilogy Evo, O2, Italy EV300; KR2200X15B Trilogy Evo, O2, Korea EV300; ND2200X15B Trilogy Evo, O2, Nordics EV300; TR2200X15B Trilogy Evo, O2, Turkey EV300;
FDA Enforcement
Class I
·Ongoing·Philips Respironics, Inc.·September 11, 2024
Trilogy Evo, Evo Clinical Korean (1137823) and Evo Caregiver Korean (1137853) Instructions for Use
FDA Enforcement
Class II
·Ongoing·Philips Respironics, Inc.·July 12, 2023
Trilogy Evo Repair Kit, RP-Trilogy Evo Muffler Assembly, Material Number 1135257 The Trilogy Evo ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg.
FDA Enforcement
Class I
·Ongoing·Philips Respironics, Inc.·February 2, 2022
Trilogy Evo, Garbin Evo, and Aeris EVO, Model Numbers DS2110X11B, IN2110X15B, JP2110X16B, AU2110X15B, LA2110X15B, CA2110X12B, BR2110X18B, KR2110X15B, IA2110X15B, FP2110X10, FR2110X14B, ND2110X15B, IT2110X21B, ES2110X15B, DE2110X13B, BL2110X15B, GB2110X15B, EU2110X15B, EE2110X15B, LD2110X23B, and VT2110X24B
FDA Enforcement
Class I
·Ongoing·Philips Respironics, Inc.·June 14, 2023
Revolution EVO, Optima CT660, Optima CT680 CT Systems.
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·July 7, 2021
Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device.
FDA Enforcement
Class I
·Ongoing·Philips Respironics, Inc.·April 1, 2026
Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device.
FDA Enforcement
Class I
·Ongoing·Philips Respironics, Inc.·April 1, 2026
Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device.
FDA Enforcement
Class I
·Ongoing·Philips Respironics, Inc.·April 1, 2026
Trilogy Evo, Material Numbers DS2110X11B (USA) and KR2110X15B (Korea) The Trilogy Evo ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg.
FDA Enforcement
Class I
·Ongoing·Philips Respironics, Inc.·February 2, 2022
CareFusion Alaris PCA Module, Model 8120
FDA Enforcement
Class I
·Ongoing·CareFusion 303, Inc.·March 11, 2020
CareFusion Alaris Syringe Module, Model 8110
FDA Enforcement
Class I
·Ongoing·CareFusion 303, Inc.·March 11, 2020
CareFusion Alaris Pump Module, Model 8100
FDA Enforcement
Class I
·Ongoing·CareFusion 303, Inc.·March 11, 2020
CareFusion Alaris System, Alaris PC unit models 8000 and 8015 (UDI: 10885403801518)
FDA Enforcement
Class I
·Ongoing·CareFusion 303, Inc.·March 11, 2020
GE SIGNA Artist Evo, Nuclear Magnetic Resonance Imaging System
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·August 20, 2025
Trilogy Evo Universal, Product number DS2000X11B
FDA Enforcement
Class II
·Ongoing·Philips Respironics, Inc.·August 25, 2021
Trilogy Evo Universal Ventilator, Model No. DS2000X11B
FDA Enforcement
Class I
·Ongoing·Philips Respironics, Inc.·September 11, 2024
Trilogy Evo Universal Ventilator, Model Number DS2000X11B
FDA Enforcement
Class I
·Ongoing·Philips Respironics, Inc.·June 14, 2023
Trilogy Evo and Trilogy Evo O2 Material Numbers BL2110X15B BR2110X18B CA2110X12B DE2100X13B DE2110X13B DS2100X11B DS2110X11B EE2100X15B EE2110X15B ES2100X15B ES2110X15B EU2100X15B EU2100X19 EU2110X15B FR2100X14B FR2110X14B FX2100X15B GB2110X15B IA2100X15B IA2110X15B IN2100X15B IN2100X19 IN2110X15B IT2100X21B IT2110X21B JP2100X16B JP2110X16B KR2110X15B LA2100X15B LA2110X15B ND2110X15B RDE2100X13B RDE2110X13B RDS2110X11B RIN2100X15B RIN2110X15B RJP2100X16B RJP2110X16B UDS2110X11B
FDA Enforcement
Class II
·Ongoing·Philips Respironics, Inc.·January 10, 2024
EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5
FDA Enforcement
Class II
·Ongoing·Staar Surgical AG·March 11, 2026