68 results
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32ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230, KTR-2220, KTR-2210, KTR-2231, KTR-2221, KTR-2211, KTR-2232, KTR-2222, KTR-2212)
FDA 510(k)
FDA Class 2
·Neurology
Bernafon
FDA UDI
Bernafon AG·05711584087022·ZR3, KIT 10 NFM 75 BE ZERENA 3
K131982
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·February 23, 2024
MERLIN PSA PATIENT CABLE EX 3150, CABLE ADAPTER EX3170, M ADAPTER EX3180
FDA 510(k)
FDA Class 2
·Cardiovascular
CLEARFIL DC CORE PLUS
FDA 510(k)
FDA Class 2
·Dental
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
DISCARDIT II 5ML WITH 24X1
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMF·June 18, 2020
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