57 results · 35ms · Sources: EU EUDAMED, US FDA

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SPECTRA SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

K091319

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

XIA SPINE SYSTEM HOOKS

FDA 510(k)
FDA Class 2 ·Orthopedic

STRYKER TITANIUM CROSS-SCREW SYSTEM, MODEL 234-500-1XX

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

LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

FDA Adverse Event
Malfunction ·PHYSIO-CONTROL, INC·Product code LDD·December 4, 2012

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

ADVANCE BED

FDA Adverse Event
Malfunction ·HILL-ROM, INC.·Product code FNL·March 26, 2013

RESTYLANE INJECTABLE GEL

FDA Adverse Event
Other ·Q-MED AB·Product code LMH·April 11, 2011

CYPHER SIROLIMUS-ELUTING CORONARY STENT

FDA Adverse Event
Injury ·CORDIS DE MEXICO·Product code NIQ·June 13, 2008

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