80 results · 25ms · Sources: EU EUDAMED, US FDA

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ITRAC CERVICAL TRACTION SYSTEM

FDA 510(k)
FDA Class 2 ·Physical Medicine

K131982

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code BZD·February 23, 2024

CRITICAL CARE ASSESSMENT

FDA 510(k)
FDA Class 2 ·Cardiovascular

INOVO, INC, ECONOMIZER CONSERVING REGULATOR

FDA 510(k)
FDA Class 2 ·Anesthesiology

BIPAP PRO BIFLEX

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code BZD·March 2, 2026

DREAMSTATION BIPAP AUTOSV

FDA Adverse Event
Malfunction ·RESPIRONICS, INC·Product code MNS·March 30, 2022

REMSTAR SYSTEM ONE 60 SERIES

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code BZD·October 31, 2024

REMSTAR SYSTEM ONE 60 SERIES

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code BZD·January 19, 2026

PROPHECY INFINITY

FDA Adverse Event
Malfunction ·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code HSN·March 29, 2021

REMSTAR AUTO

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code BZD·August 20, 2021

REMSTAR PRO

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code BZD·August 20, 2021

DREAMSTATION BIPAP AUTOSV

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code MNS·March 30, 2022

OMNILAB ADVANCED PLUS

FDA Adverse Event
Malfunction ·RESPIRONICS, INC·Product code MNS·March 31, 2022

REMSTAR PLUS

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code BZD·January 5, 2026

REMSTAR AUTOA-FLEX

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code BZD·May 20, 2022

REMSTAR AUTO A-FLEX W/HUMID

FDA Adverse Event
Malfunction ·RESPIRONICS, INC·Product code BZD·August 10, 2021

REMSTAR PLUS C-FLEX

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code BZD·January 5, 2026

DREAMSTATION BIPAP AUTOSV

FDA Adverse Event
Malfunction ·RESPIRONICS, INC·Product code MNS·March 30, 2022

PHILIPS CPAP DEVICE

FDA Adverse Event
Injury ·RESPIRONICS, INC.·Product code BZD·May 8, 2024

REMSTAR AUTO A-FLEX, SYS ONE, 60 SRS,GER

FDA Adverse Event
Injury ·RESPIRONICS INC·Product code BZD·August 30, 2021