32 results
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21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Monarch Airway Clearance System
FDA 510(k)
FDA Class 2
·Anesthesiology
3M™ Unitek™
FDA UDI
3M UNITEK CORPORATION·00652221046321·Unitek(TM) Molar Band General Purpose Wide Hard...
CONFORMIS ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CIRRUS HD-OCT, MODEL 4000
FDA 510(k)
FDA Class 2
·Ophthalmic
KANEKA PTCA CATHETER CO-R7 (IKAZUCHI ZERO)
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LOX·March 17, 2020
MBT CEM KEEL TIB TRAY SZ2
FDA Adverse Event
Injury
·DEPUY (IRELAND)·Product code NJL·July 8, 2011
BCS(R) XP
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH·Product code GKP·June 11, 2013
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·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
KANEKA PTCA CATHETER CO-R7 (IKAZUCHI ZERO)
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LOX·December 21, 2017
KANEKA PTCA CATHETER CO-R7 (IKAZUCHI ZERO)
FDA Adverse Event
Death
·KANEKA CORPORATION·Product code LOX·April 14, 2021