4,797 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Accu-O-Matic
FDA UDI
ETD Electro-Therapeutic Devices Inc·00628235150057·Advance Transcutaneous Electrical Nerve Stimulator
ETD Family of Electrotherapy Devices
FDA 510(k)
FDA Class 2
·Physical Medicine
A-COMPANY ELECTROTHERMAL DEBONDING DEVICE (ETD)
FDA 510(k)
FDA Class 1
·Dental
CHRONOS VISION EYE TRACKING DEVICE (C-ETD)
FDA 510(k)
FDA Class 2
·Neurology
EVIS EXERAIII BRONCHOVIDEOSCOPE
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORP.·Product code EOQ·April 8, 2022
EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE
FDA Adverse Event
Malfunction
·AIZU OLYMPUS CO., LTD.·Product code FDS·May 25, 2023
SINGLE USE ELECTROSURGICAL KNIFE KD-612
FDA Adverse Event
Injury
·AOMORI OLYMPUS CO., LTD.·Product code KNS·September 16, 2025
EVIS LUCERA ELITE COLONOVIDEOSCOPE
FDA Adverse Event
Injury
·AIZU OLYMPUS CO., LTD.·Product code FDF·September 16, 2025
EVIS EXERAII BRONCHOVIDEOSCOPE
FDA Adverse Event
Injury
·OLYMPUS MEDICAL SYSTEMS CORP.·Product code EOQ·December 23, 2021
EVIS EXERA II COLONOVIDEOSCOPE
FDA Adverse Event
Malfunction
·AIZU OLYMPUS CO., LTD.·Product code FDF·May 25, 2023
EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORP.·Product code FDS·November 3, 2021
EVIS EXERA DUODENOVIDEOSCOPE
FDA Adverse Event
Injury
·OLYMPUS MEDICAL SYSTEMS CORP.·Product code FDT·July 11, 2017
EVIS EXERA DUODENOVIDEOSCOPE
FDA Adverse Event
Injury
·OLYMPUS MEDICAL SYSTEMS CORP.·Product code FDT·July 11, 2017
TJF-145-U
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORP.·Product code FDT·April 13, 2017
TJF-145-U
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORP.·Product code FDT·April 12, 2017
EVIS EXERA LLL COLONOVIDEOSCOPE
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORP.·Product code FDF·February 24, 2022
ExacTrac Dynamic software model numbers: 20910-01, ETD Positioning and Moni. 1.0.0 INST; 20910-01A, ETD Positioning and Moni. 1.0.1 INST; 20910-01B, ETD Positioning and Moni. 1.0.2 INST; and 20910-01C ETD Positioning and Moni. 1.0.3 INST.
FDA Recall
Open, Classified
·Brainlab AG Olof-palme-str. 9 Munich Germany·Product code IYE·February 25, 2022
EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE
FDA Adverse Event
Injury
·OLYMPUS MEDICAL SYSTEMS CORP.·Product code PSV·December 23, 2021
OES CYSTONEPHROFIBERSCOPE
FDA Adverse Event
Injury
·OLYMPUS MEDICAL SYSTEMS CORP.·Product code FAJ·September 20, 2017
ExacTrac Dynamic software model numbers: 20910-01, ETD Positioning and Moni. 1.0.0 INST; 20910-01A, ETD Positioning and Moni. 1.0.1 INST; 20910-01B, ETD Positioning and Moni. 1.0.2 INST; and 20910-01C ETD Positioning and Moni. 1.0.3 INST.
FDA Enforcement
Class II
·Ongoing·Brainlab AG·March 16, 2022