54 results · 25ms · Sources: EU EUDAMED, US FDA

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DEVILBISS INTELLIPAP/SLEEPCUBE BILEVEL S/ST

FDA 510(k)
FDA Class 2 ·Anesthesiology

K091319

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code BZD·January 9, 2026

WAKO AUTOKIT LP(A)/DADE DEMENSION

FDA 510(k)
FDA Class 2 ·Immunology

SCS CLARIS SPINAL SYSTEM,REXTENDED OMNIAXIAL CONNECTOR-,MEDIUM, MODEL CO05, SCS CLARIS SPINAL SYSTEM,EXTENDED OMNIAXIALO

FDA 510(k)
FDA Class 2 ·Orthopedic

REMSTAR AUTO A-FLEX

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code BZD·January 12, 2026

REMSTAR AUTO A-FLEX, SYS ONE, 60 SRS, FR

FDA Adverse Event
Injury ·RESPIRONICS, INC·Product code BZD·August 5, 2021

REMSTAR PRO C-FLEX

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code BZD·December 31, 2025

REMSTAR

FDA Adverse Event
Injury ·RESPIRONICS, INC.·Product code BZD·October 22, 2024

BIPAP PRO BIFLEX

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code BZD·March 5, 2026

REMSTAR

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code BZD·October 28, 2024

DREAMSTATION AUTO CPAP

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

REMSTAR PRO C-FLEX+

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

INFUSE BONE GRAFT

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·May 3, 2013

EON MINI

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·August 28, 2014

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 18, 2011

REMSTAR PLUS C-FLEX

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code BZD·July 17, 2024

REMSTAR PLUS C-FLEX

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code BZD·January 5, 2026

REMSTAR PRO C-FLEX+

FDA Adverse Event
Malfunction ·RESPIRONICS INC·Product code BZD·May 20, 2022

REMSTAR AUTO A-FLEX

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

DREAMSTATION AUTO CPAP

FDA Adverse Event
Injury ·RESPIRONICS, INC.·Product code BZD·December 16, 2024