11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
FX V 135 stem
FDA UDI
FX SOLUTIONS·03701037315200·FX V 135 stem TA6V Ø36/16 cementless Ti/HA
ZenFlex CM
FDA UDI
Kerr Corporation·00195062145728·.30/.06/21mm ZenFlex CM NiTi FILE REFILL PACK
PINPOINT STEREOTACTIC HEAD AND NECK LOCALIZER
FDA 510(k)
FDA Class 2
·Radiology
PATHOLASE FAMILY OF PINPOINTE AND PINPOINTE FOOTLASER ND: YAG LASERS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PFNA-II Ø9 XS 130° L170 TAN
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HRS·June 22, 2013
COLLEAGUE VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 4, 2008
COULTER LH 750 HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code GKZ·July 8, 2011
PLATE, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HRS·October 3, 2016
PLATE, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HRS·August 26, 2016
Olympus Sterile Optical Laser Fiber, single use and reusable
FDA Enforcement
Class II
·Terminated·Quanta System, S.p.A.·June 16, 2021