16 results
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12ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Continuous Ventilator/Continuous Ventilator with Respiratory Mechanics, Model No. V1000
FDA Enforcement
Class II
·Terminated·Respironics California Inc·September 4, 2013
Philips V60 Ventilator with Version 2.20 Software, Description: V 60 Ventilator,Intl Opt: CFLEX,AVAPS,PPV V60 Ventilator,Intl Opt: CFLEX,AVAPS V60 Ventilator,Intl Opt: None V60 Ventilator,English Opt: None V60 Ventilator,Engl Opt: CFLEX,AVAPS V60 Us Demo Unit V60 USED ENGL OPT:CFLEX, AVAPS,PPV,AT+cl V60 VENT, JAPAN OPT: CFLEX, AVAPS, AT+ V60 VENT, JAPAN OPT: CFLEX, AVAPS, AT+ Catalog/REF No. 1053613, 1053614, 1053615, 1053616, 1053617, DU1053617, U1053617, 1076709, R1076709
FDA Enforcement
Class II
·Terminated·Respironics California Inc·April 5, 2017
Esprit V1000 Ventilator and Esprit/V200 Conversion Ventilator The Esprit V1000 and Esprit/V200 Conversion Ventilators are microprocessor-controlled, electrically powered mechanical ventilators. Intended for use by medical personnel to provide continuous or intermittent ventilator support for adult, pediatric and neonatal patients.
FDA Enforcement
Class II
·Terminated·Respironics California Inc·December 3, 2014
BiPAP A40 System Silver, JP: Continuous ventilator, non-life-supporting. Material Number: R1111177
FDA Enforcement
Class II
·Terminated·Philips Respironics, Inc.·June 2, 2021
BiPAP A40, Brazil: Continuous ventilator, non-life-supporting. Material Number: BR1111169
FDA Enforcement
Class II
·Terminated·Philips Respironics, Inc.·June 2, 2021
BiPAP V30 Auto, US market: Continuous ventilator, non-life-supporting. Material Number: 1111178
FDA Enforcement
Class II
·Terminated·Philips Respironics, Inc.·June 2, 2021
BiPAP A40, China: Continuous ventilator, non-life-supporting. Material Number - CN1111169
FDA Enforcement
Class II
·Terminated·Philips Respironics, Inc.·June 2, 2021
BiPAP A40 System Silver, JP: Continuous ventilator, non-life-supporting. Material Number: 1111177
FDA Enforcement
Class II
·Terminated·Philips Respironics, Inc.·June 2, 2021
Trilogy Evo, Product numbers BL2110X15B, CA2110X12B, DE2110X13B, DS2110X11B, EE2110X15B, ES2110X15B, EU2110X15B, EU2110X19, FR2110X14B, GB2110X15B, IA2110X15B, IN2110X15B, IN2110X19, IT2110X21B, KR2110X15B, LA2110X15B, LD2110X23B, ND2110X15B, RDE2110X13B, UDS2110X11B
FDA Enforcement
Class II
·Ongoing·Philips Respironics, Inc.·August 25, 2021
Trilogy EV300, Product numbers CA2200X12B, DS2200X11B, FX2200X15B, IN2200X15B
FDA Enforcement
Class II
·Ongoing·Philips Respironics, Inc.·August 25, 2021
Trilogy Evo Universal, Product number DS2000X11B
FDA Enforcement
Class II
·Ongoing·Philips Respironics, Inc.·August 25, 2021
Trilogy Evo O2, Product numbers DE2100X13B, DS2100X11B, EE2100X15B, ES2100X15B, EU2100X15B, FR2100X14B, FX2100X15B, IA2100X15B, IN2100X15B, IN2100X19, IT2100X21B, JP2100X16B, LA2100X15B, ND2100X15B, RDE2100X13B, SP2100X26B
FDA Enforcement
Class II
·Ongoing·Philips Respironics, Inc.·August 25, 2021
BiPAP A30, Brazil: Continuous ventilator, non-life-supporting. Material Number: BR1111143
FDA Enforcement
Class II
·Terminated·Philips Respironics, Inc.·June 2, 2021
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 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
SimplyGo Mini, Standard Battery Kit; Product code: 1116816; The affected battery kits are sold as accessories for the SimplyGo Mini: SimplyGo Mini Portable Oxygen Concentrator Product code: 1113600
FDA Enforcement
Class II
·Ongoing·Philips Respironics, Inc.·November 19, 2025