10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ALVUE Balloon Dilation System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HYDROCOIL EMBOLIC SYSTEMS (HES)
FDA 510(k)
FDA Class 2
·Cardiovascular
OSTEOBRIDGE IKA INTRAMEDULLARY KNEE ARTHRODESIS ROD FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 7, 2013
CAPSUREFIX NOVUS
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·July 22, 2011
LIFEPAK CR PLUS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code LDD·September 19, 2008
CUSTOM PACK CB1Q91R6 NTUH CCS
FDA Adverse Event
Malfunction
·MEDTRONIC MEXICO·Product code DWE·June 22, 2022
CONQUEST PRO 12 ST
FDA Adverse Event
Injury
·ASAHI INTECC CO., LTD.·Product code DQX·July 16, 2025
MEMORY II DOUBLE LUMEN EXTRACTION BASKET
FDA Adverse Event
Malfunction
·COOK ENDOSCOPY·Product code LQR·July 28, 2021
ASTATO XS 9-12
FDA Adverse Event
Malfunction
·ASAHI INTECC CO., LTD.·Product code DQX·June 24, 2025