36 results · 24ms · Sources: EU EUDAMED, 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