51 results · 37ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

K131982

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code BZD·February 23, 2024

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

DREAMSTATION AUTO CPAP

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code BZD·April 10, 2025

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 10, 2014

7700

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·June 3, 2013

REMSTAR AUTOA-FLEX

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code BZD·March 2, 2026

REMSTAR PLUS

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code BZD·January 7, 2026

REMSTAR AUTO A-FLEX

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code BZD·May 23, 2022