59 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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COVIDIEN EXTENDED TIP APPLICATOR
FDA 510(k)
FDA Class 2
·General Hospital
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450459669·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450431238·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450545744·
K091319
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·January 9, 2026
MODIFICATION TO KION ANESTHESIA SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
SSD 5500 WITH OLYMPUS GF TYPE UC140P-AL5
FDA 510(k)
FDA Class 2
·Radiology
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
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·January 9, 2014
REMSTAR PRO C-FLEX+
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·January 7, 2026
SPECTRUM MONITOR
FDA Adverse Event
Malfunction
·MINDRAY DS USA, INC.·Product code MHX·April 30, 2013
BATT-HANDPIECE MOD F/TRS
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code GEY·September 16, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·May 17, 2011
REMSTAR PLUS C-FLEX
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·July 17, 2024