33 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Oxitone 1000
FDA 510(k)
FDA Class 2
·Cardiovascular
3M™ Unitek™
FDA UDI
3M UNITEK CORPORATION·00652221046369·Unitek(TM) Molar Band General Purpose Wide Hard...
HDR CT COMPATIBLE SPLIT RING APPLICATOR
FDA 510(k)
FDA Class 2
·Radiology
INTERCONTINENTAL PLATE-SPACER
FDA 510(k)
FDA Class 2
·Orthopedic
KANEKA PTCA CATHETER CO-R7 (IKAZUCHI ZERO)
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LOX·March 17, 2020
ASR ACETABULAR CUPS 56
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·July 8, 2011
ASCENDRA DELIVERY SYSTEM
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·June 11, 2013
ACS RX ESPRIT CORONARY DILATATION CATHETERS (PERFUSION)
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code LOX·September 10, 2008
IKAZUCHI ZERO
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LOX·June 13, 2019
KANEKA PTCA CATHETER CO-R7 (IKAZUCHI ZERO)
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LOX·August 19, 2019
IKAZUCHI ZERO
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LOX·August 20, 2019
KANEKA PTCA CATHETER CO-R7(IKAZUCHI ZERO)
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LOX·August 21, 2019
KANEKA PTCA CATHETER CO-R7 (IKAZUCHI ZERO)
FDA Adverse Event
Malfunction
·KANEKA CORPORATION·Product code LOX·April 14, 2022
KANEKA PTCA CATHETER CO-R8 (TASUKI)
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LOX·December 13, 2020
KANEKA PTCA CATHETER CO-R7 (IKAZUCHI ZERO)
FDA Adverse Event
Malfunction
·KANEKA CORPORATION·Product code LOX·December 21, 2020
KANEKA PTCA CATHETER CO-R7 (IKAZUCHI ZERO)
FDA Adverse Event
Malfunction
·KANEKA CORPORATION·Product code LOX·April 13, 2022
KANEKA PTCA CATHETER CO-R6 (RAIDEN3)
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LOX·June 6, 2025
KANEKA PTCA CATHETER ZINRAI
FDA Adverse Event
Death
·KANEKA CORPORATION·Product code LOX·February 3, 2025
GMK-SPHERE FEMORAL COMPONENT CEMENTED # 3+ L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·December 13, 2017
KANEKA PTCA CATHETER CO-R7 (IKAZUCHI ZERO)
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LOX·December 21, 2017