69 results · 28ms · Sources: EU EUDAMED, US FDA

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GEODESICEEG SYSTEM 400 SERIES (GES 400)

FDA 510(k)
FDA Class 2 ·Neurology

Oticon

FDA UDI
Oticon A/S·05707131259295·NERA, KIT 312 DIR R H BE

K131982

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

ENDOSCOPIC APPLICATOR

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

PRONTOSAN ANTIMICROBIAL WOUND GEL

FDA 510(k)
FDA Unclassified ·Unknown

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

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