61 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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REVOLUTION FEMORAL INTRAMEDULLARY NAIL SYSTEM, MODEL DGOOXX
FDA 510(k)
FDA Class 2
·Orthopedic
LEONE SPA
FDA UDI
LEONE SPA·08033707065753·INTRAORAL ELASTICS 6,5 oz 5/16" blue
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450399149·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450405918·
K091319
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·January 9, 2026
LUTE VLC; CORE VLC
FDA 510(k)
FDA Class 2
·Dental
HYDRO-CAST BIS-ACRYL TEMPORARY CROWN AND BRIDGE MATERIAL, MODEL 98250
FDA 510(k)
FDA Class 2
·Dental
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
PASSPORT 2 MONITOR
FDA Adverse Event
Malfunction
·MINDRAY DS USA, INC.·Product code MHX·April 30, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·September 16, 2014
X8000 LIGHTSOURCE
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY SAN JOSE·Product code FCW·May 4, 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