93 results · 19ms · Sources: EU EUDAMED, 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