36 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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PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope EG29-i20c, PENTAX Medical Video Colonoscope EC38-i20cL
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code PEA·June 14, 2024
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code PEA·July 22, 2024
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDS·January 10, 2025
ON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-SERIES
FDA 510(k)
FDA Class 2
·General Hospital
MODIFICATION TO STRYKER PAINPUMP
FDA 510(k)
FDA Class 2
·General Hospital
SYRINGE 1.0ML 31GA 8MM 10BAG 500 WAL
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·April 15, 2020
SWAN-GANZ VIP
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES DR·Product code DYG·February 26, 2026
SWAN-GANZ VIP
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES PR·Product code DYG·April 1, 2026
SWAN-GANZ VIP
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES PR·Product code DYG·April 1, 2026
SWAN-GANZ VIP
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES, PR·Product code DYG·April 12, 2026
SWAN-GANZ VIP
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES PR·Product code DYG·August 13, 2025
SWAN-GANZ VIP
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES PR·Product code DYG·April 1, 2026
GE OEC 9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·November 13, 2008
X8000 LIGHTSOURCE
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY SAN JOSE·Product code FCW·July 25, 2011
PRIME BIG WHEEL STRETCHER 26"
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FPO·July 17, 2013
SWAN-GANZ VIP
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES PR·Product code DYG·November 26, 2025
SWAN-GANZ VIP
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES PR·Product code DYG·August 20, 2025
SWAN-GANZ VIP
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES, PR·Product code DYG·April 10, 2026
SWAN-GANZ VIP
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES, PR·Product code DYG·April 11, 2026