156 results · 24ms · Sources: EU EUDAMED, US FDA

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Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US)

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

HeartFlow Analysis

FDA 510(k)
FDA Class 2 ·Cardiovascular

i-STAT G3+ cartridge with the i-STAT 1 System

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

DREAMSTATION AUTO CPAP

FDA Adverse Event
Injury ·RESPIRONICS, INC.·Product code BZD·October 20, 2021

DREAMSTATION AUTO CPAP

FDA Adverse Event
Malfunction ·RESPIRONICS, INC·Product code BZD·February 14, 2022

XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

FDA Adverse Event
Malfunction ·AV-TEMECULA-CT·Product code NIQ·November 11, 2014

INRATIO

FDA Adverse Event
Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·July 29, 2011

RESERVOIR 3ML

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·July 23, 2013

DREAMSTATION BIPAP AUTOSV

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code MNS·August 9, 2023

DREAMSTATION

FDA Adverse Event
Injury ·RESPIRONICS, INC.·Product code BZD·December 11, 2024

DREAMSTATION AUTO CPAP

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code BZD·May 15, 2025

REP DREAMSTATION AUTO CPAP, JP

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code BZD·April 29, 2025

DREAMSTATION AUTO CPAP

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code BZD·February 27, 2023

DREAMSTATION AUTO CPAP

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code BZD·July 29, 2022

DREAMSTATION AUTO CPAP

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code BZD·August 11, 2022

DREAMSTATION CPAP

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code BZD·August 1, 2022

DREAMSTATION AUTO CPAP

FDA Adverse Event
Injury ·RESPORINOC INC·Product code BZD·May 6, 2022

DREAMSTATION AUTO CPAP

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code BZD·August 31, 2022

DREAMSTATION AUTO CPAP

FDA Adverse Event
Injury ·RESPIRONICS, INC.·Product code BZD·July 27, 2022

DREAMSTATION HUMID

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code BZD·November 11, 2025