65 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NEW ENGLAND MEDICAL GROUNDING PAD
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
K131982
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·February 23, 2024
BIRDSONG LEVERHALER, MODEL LH-1000
FDA 510(k)
FDA Class 2
·Anesthesiology
REMSTAR AUTO A-FLEX HT
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
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
DREAMSTATION AUTO CPAP
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·April 10, 2025