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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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KSI CO., LTD.
FDA registration
KSI CO., LTD.·27 products·🇯🇵 Japan
KSI'S NEW CAMERA ARCHITECTURE (NCA) VIDEO IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SCREWDRIVER
FDA Adverse Event
Injury
·KSI·Product code HXX·August 12, 2023
SCREWDRIVER
FDA Adverse Event
Injury
·KSI·Product code HXX·August 12, 2023
LIGHT CABLE, 3.5MM X 300CM. LGTH 9.8 FT
FDA Adverse Event
Injury
·KARL STORZ SE & CO. KG·Product code FCW·November 30, 2023
LIGHT CABLE, 3.5MM X 300CM. LGTH 9.8 FT
FDA Adverse Event
Injury
·KARL STORZ SE & CO. KG·Product code FCW·November 27, 2023
LIGHT CABLE, 3.5MM X 300CM. LGTH 9.8 FT
FDA Adverse Event
Injury
·KARL STORZ SE & CO. KG·Product code FCW·November 30, 2023
HYS SS 480MM ROD, 160 KSI
FDA Adverse Event
Injury
·DEPUY SYNTHES SPINE·Product code NKB·April 22, 2015
RFNA / 11MM / 200MM STANDARD BEND / STERILE
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HSB·September 3, 2024
4.2MM THREE-FLUTED DRILL BIT QC/330MM/100MM CALIB-STERILE
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HTW·September 3, 2024
UNK - SCREWS: LOCKING
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWC·March 13, 2023
PL 1-HO F/FEM NECK SYST TAN
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code KTT·March 13, 2023
LIGHT CABLE, 3.5MM X 300CM. LGTH 9.8 FT
FDA Adverse Event
Injury
·KARL STORZ SE & CO. KG·Product code FCW·November 27, 2023
11.0MM TI HELICAL BLADE 85MM-STERILE
FDA Adverse Event
Injury
·SYNTHES ELMIRA·Product code HSB·August 27, 2013
CCU,MODULAR,4U-LINK,US
FDA Adverse Event
Malfunction
·KARL STORZ IMAGING·Product code FET·March 10, 2025
11.0MM TI HELICAL BLADE 85MM
FDA Adverse Event
Injury
·SYNTHES ELMIRA·Product code HSB·October 29, 2013
11.0MM TI HELICAL BLADE 95MM-STERILE
FDA Adverse Event
Malfunction
·SYNTHES ELMIRA·Product code HSB·March 29, 2013
CCU,MODULAR,X-LINK,INTL,CE
FDA Adverse Event
Malfunction
·KARL STORZ IMAGING·Product code FET·November 1, 2024
CCU,MODULAR,IMAGE1 S X-LINK,US
FDA Adverse Event
Malfunction
·KARL STORZ IMAGING·Product code FET·November 12, 2024
11.0MM TI HELICAL BLADE 90MM
FDA Adverse Event
Injury
·SYNTHES ELMIRA·Product code HSB·October 16, 2013