93 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CLEARFIL DC CORE PLUS
FDA 510(k)
FDA Class 2
·Dental
Relief Pak 6 pack heating Unit
FDA UDI
KARIS Co.,Ltd·08809520550222·It is a device intended for medical purposes th...
Relief Pak 6 pack heating Unit stationary
FDA UDI
KARIS Co.,Ltd·08809520550543·It is a device intended for medical purposes th...
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
0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
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
UNSPECIFIED 10ML FILL IN 10ML BD¿ PRE-FILLED NORMAL SALINE FILLED FLUSH
FDA Adverse Event
Death
·BECTON DICKINSON·Product code FOZ·April 1, 2016
DREAMSTATION BIPAP AUTOSV
FDA Adverse Event
Malfunction
·RESPIRONICS, INC·Product code MNS·March 30, 2022