38 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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URITEK TC-201 URINE CHEMISTRY TEST SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
3M™ Unitek™
FDA UDI
3M UNITEK CORPORATION·00652221045225·Unitek(TM) Molar Band General Purpose Wide Regu...
SAFECT MODEL VER 1.0
FDA 510(k)
FDA Class 2
·Radiology
INTRALASE FS LASER, INTRALASE FS30 LASER, MODELS 1, 2, 3
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
INTRALASE FS2
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code HNO·November 21, 2013
KANEKA PTCA CATHETER CO-R7 (IKAZUCHI ZERO)
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LOX·March 17, 2020
VISX EXCIMER LASER
FDA Adverse Event
Injury
·AMO MANUFACTURING USA LLC·Product code LZS·November 5, 2010
INTRALASE FS2
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code HNO·August 20, 2013
INTRALASE FS2
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code HNO·October 30, 2013
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 10, 2013
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Malfunction
·COCHLEAR LTD.·Product code MCM·July 13, 2011
COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 16, 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
BD LUER-LOK
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMF·November 10, 2025
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