Product Code: FDT


Products Classified as FDT

1775Duodenoscope And Accessories, Flexible/rigidEndoscope And Accessories.

Total Product Life Cycle (TPLC) Devices

1775Duodenoscope And Accessories, Flexible/rigidEndoscope And Accessories.

FDA Consensus Standards

Duodenoscope And Accessories, Flexible/Rigid [32386]21 CFR §876.1500 🔎
Duodenoscope And Accessories, Flexible/Rigid [30564]21 CFR §876.1500 🔎
Duodenoscope And Accessories, Flexible/Rigid [30563]21 CFR §876.1500 🔎
Duodenoscope And Accessories, Flexible/Rigid [33513]21 CFR §876.1500 🔎
Duodenoscope And Accessories, Flexible/Rigid [36928]21 CFR §876.1500 🔎
Duodenoscope And Accessories, Flexible/Rigid [31951]21 CFR §876.1500 🔎

Pre-market Notifications for FDT

K220587Evis Exera III Duodenovideoscope Olympus TJF-Q190VOlympus Medical Systems Corp.
K210710PENTAX Medical Video Duedenoscope ED34-i10T2PENTAX Of America, Inc.
K203028FUJIFILM Distal End CapFujifilm Corporation
K202661Evis Exera III Duodenovideoscope Olympus TJF-Q190VOlympus Medical Systems Corp.
K202365Pentax Medical Video Duodenoscope ED32-i10Pentax Of America, Inc.
K201098Ambu Duodeno SystemAmbu Innovation GmbH
K193202EXALT Model D Single-Use Duodenoscope, EXALT ControllerBoston Scientific Corporation
K193182Evis Exera III Duodenovideoscope Olympus TJF-Q190VOlympus Medical Systems Corp.
K192280PENTAX Medical ED-3490TK Video DuodenoscopePentax Medical
K192245Pentax Medical Video Duodenoscope ED34-i10T2PENTAX Of America, Inc.
K191747FUJIFILM Duodenoscope Model ED-580XTFUJIFILM Corporation
K182051FUJIFILM Duodenoscope ModelFUJIFILM Corporation
K181745FUJIFILM Duodenoscope ModelFUJIFILM Corporation
K181522PENTAX MEDICAL ED-3490TK, Video Duodenoscope, PENTAX Medical ED34-i10T, Video DuodenoscopePENTAX Of America, Inc.
K163614PENTAX Medical ED34-i10T, Video DuodenoscopePENTAX Medical

Global Unique Device Identification Database

04961333243365Duodenoscope And Accessories, Flexible/Rigid
04961333240142Duodenoscope And Accessories, Flexible/Rigid
04961333240135Duodenoscope And Accessories, Flexible/Rigid
04961333240128Duodenoscope And Accessories, Flexible/Rigid
04961333232956Duodenoscope And Accessories, Flexible/Rigid
04961333232420Duodenoscope And Accessories, Flexible/Rigid
04961333229611duodenoscope and accessories, flexible/rigid
04961333225903duodenoscope and accessories, flexible/rigid
04961333073030duodenoscope and accessories, flexible/rigid
04961333071142duodenoscope and accessories, flexible/rigid
04961333070459duodenoscope and accessories, flexible/rigid
04961333070442duodenoscope and accessories, flexible/rigid
14953170368612duodenoscope and accessories, flexible/rigid
04953170355738duodenoscope and accessories, flexible/rigid
04953170339851duodenoscope and accessories, flexible/rigid

Maude Adverse Events

EVIS LUCERA DUODENOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-31
EVIS EXERA III DUODENOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-28
EVIS EXERA III DUODENOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-28
EVIS EXERA II DUODENOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-28
PENTAXHOYA CORPORATION PENTAX TOKYO OFFICE2020-03-27
PENTAXHOYA CORPORATION PENTAX TOKYO OFFICE2020-03-27
EVIS LUCERA DUODENOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-26
EVIS EXERA II DUODENOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-25
EVIS LUCERA DUODENOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-24
EVIS EXERA II DUODENOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-19
EVIS EXERA III DUODENOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-19
SINGLE USE DISTAL COVEROLYMPUS MEDICAL SYSTEMS CORP.2020-03-19
EVIS EXERA DUODENOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-17
EVIS EXERA DUODENOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-17
PENTAXHOYA CORPORATION PENTAX TOKYO OFFICE2020-03-17
EVIS EXERA II DUODENOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-17
EVIS EXERA II DUODENOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-16
EVIS EXERA DUODENOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-15
EVIS EXERA II DUODENOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-13
PENTAXHOYA CORPORATION PENTAX TOKYO OFFICE2020-03-12
PENTAXHOYA CORPORATION PENTAX TOKYO OFFICE2020-03-11
FUJIFILM DUODENOSCOPEFUJIFILM CORPORATION2020-03-11
FUJIFILM DUODENOSCOPEFUJIFILM CORPORATION2020-03-11
EVIS EXERA III DUODENOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-11
EVIS EXERA III DUODENOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-11
EVIS LUCERA DUODENOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-11
EVIS LUCERA DUODENOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-11
EVIS EXERA DUODENOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-11
EVIS EXERA II DUODENOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-10
EVIS LUCERA ELITE DUODENOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-09
EVIS EXERA III DUODENOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-06
EVIS LUCERA DUODENOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-06
EVIS LUCERA DUODENOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-06
EVIS LUCERA DUODENOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-06
EVIS LUCERA DUODENOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-06
EVIS LUCERA DUODENOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-06
EVIS LUCERA DUODENOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-06
EVIS LUCERA DUODENOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-06
EVIS LUCERA DUODENOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-06
EVIS LUCERA DUODENOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-06
EVIS LUCERA DUODENOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-06
EVIS LUCERA DUODENOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-06
EVIS LUCERA DUODENOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-06
EVIS LUCERA DUODENOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-06
EVIS LUCERA DUODENOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-05
EVIS LUCERA DUODENOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-05
EVIS EXERA III DUODENOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-05
EVIS EXERA II DUODENOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-04
PENTAXHOYA CORPORATION PENTAX TOKYO OFFICE2020-03-04
EVIS LUCERA DUODENOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-04

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