69 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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