439 results · 176ms · Sources: EU EUDAMED, US FDA

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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