18 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Zimmon Needle Knife Papillotome
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
T-PORT HP INFUSION PORT
FDA 510(k)
FDA Class 2
·General Hospital
VIPER SYSTEM, EXPEDIUM SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
TRUWAVE
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES DR·Product code DXO·May 28, 2026
TRUWAVE
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES DR·Product code DXO·April 22, 2026
PLUM A+ SOFTWARE MODULE, LIST #20791, SN UNK
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·June 10, 2013
CAPSUREFIX NOVUS
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·July 22, 2011
CONTURA MULTI-LUMEN BALLOON APPLICATOR
FDA Adverse Event
Malfunction
·SENORX·Product code JAQ·September 22, 2008
TRUWAVE
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code DXO·May 9, 2025
TRUWAVE
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES DR·Product code DXO·March 27, 2025
TRUWAVE
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES DR·Product code DXO·April 21, 2026
TRUWAVE
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES DR·Product code DXO·August 21, 2024
TRUWAVE
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES DR·Product code DXO·April 10, 2025
TRUWAVE
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES DR·Product code DXO·September 5, 2025
CAPTURA HOT BIOPSY FORCEPS
FDA Adverse Event
Injury
·WILSON-COOK MEDICAL INC·Product code KGE·December 2, 2024
CONQUEST PRO 12 ST
FDA Adverse Event
Injury
·ASAHI INTECC CO., LTD.·Product code DQX·July 16, 2025
ASTATO XS 9-12
FDA Adverse Event
Malfunction
·ASAHI INTECC CO., LTD.·Product code DQX·June 24, 2025
Ingenia 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781342 781377
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021