439 results
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176ms
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Sources: EU EUDAMED, US FDA
A & A OPTICAL CO.
FDA registration
A & A OPTICAL CO.·1 product·🇺🇸 United States
CERALAS
FDA Adverse Event
BIOLITEC·Product code GEX·August 18, 2008
INTIMA
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS·Product code FOZ·August 13, 1997
ONE TOUCH II
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code CFR·June 20, 1997
ONE TOUCH
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code CFR·August 6, 1997
OPTICAL BIOMETER AL-Scan: Software Version: 1.09 and earlier. Ophthalmic: The OPTICAL BIOMETER AL-Scan is a measuring device that can measure as a single unit the values necessary to calculate the power of an IOL for cataract surgery such as axial length, corneal curvature radius, and anterior chamber depth. It measures these necessary values successively through a non-contact optical measurement method.
FDA Enforcement
Class II
·Terminated·Nidek Inc·August 24, 2016
ONE TOUCH BASIC
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code CFR·October 10, 1997
ONE TOUCH
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code CFR·May 23, 1997
RAPIDPOINT 500E BLOOD GAS SYSTEM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code CHL·November 11, 2024
ONE TOUCH BASIC
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code CFR·May 22, 1997
3002637618-2018-00031
FDA Adverse Event
Malfunction
·March 20, 2018
EYE GLASS
FDA Adverse Event
CORRECT OPTICAL·Product code HOI·November 15, 1993
EVIS LUCERA ELITE DUODENOVIDEOSCOPE
FDA Adverse Event
Injury
·AIZU OLYMPUS CO., LTD.·Product code FDT·December 12, 2023
BIOPSY FORCEPS
FDA Adverse Event
Injury
·AOMORI OLYMPUS CO., LTD.·Product code FCL·December 12, 2023
SINGLE USE 3-LUMEN SPHINCTEROTOME V
FDA Adverse Event
Injury
·AOMORI OLYMPUS CO., LTD.·Product code KNS·December 12, 2023
EVIS LUCERA DUODENOVIDEOSCOPE
FDA Adverse Event
Injury
·AIZU OLYMPUS CO., LTD.·Product code FDT·December 11, 2023
EVIS DUODENOVIDEOSCOPE
FDA Adverse Event
Injury
·AIZU OLYMPUS CO., LTD.·Product code FDT·December 12, 2023
TECNIS 1-PIECE
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL OPTICS·Product code HQL·July 21, 2017
ONE TOUCH II
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code CFR·April 11, 1997
RAPIDPOINT 500E BLOOD GAS SYSTEM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code CHL·March 21, 2024