FDA

Product Code: FDA


Products Classified as FDA

1764Enteroscope And AccessoriesEndoscope And Accessories.

Total Product Life Cycle (TPLC) Devices

1764Enteroscope And AccessoriesEndoscope And Accessories.

FDA Consensus Standards

Enteroscope And Accessories [32386]21 CFR §876.1500 🔎
Enteroscope And Accessories [30564]21 CFR §876.1500 🔎
Enteroscope And Accessories [30563]21 CFR §876.1500 🔎
Enteroscope And Accessories [33513]21 CFR §876.1500 🔎
Enteroscope And Accessories [36928]21 CFR §876.1500 🔎
Enteroscope And Accessories [31951]21 CFR §876.1500 🔎

Pre-market Notifications for FDA

K213195Balloon BS-3FUJIFILM Corporation
K183683FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, And EN-450T5FUJIFILM Corporation
K183032FUJIFILM Double Balloon Endoscope EI580BTFUJIFILM Corporation
K143556Fujifilm Double Balloon Endoscopes Models EN-530T And EN-580TFUJIFILM MEDICAL SYSTEMS U.S.A., INC.
K071254SMALL INTESTINAL VIDEOSCOPE SYSTEMOLYMPUS MEDICAL SYSTEMS CORPORATION
K060923NAVIAID BGE DEVICE, MODEL 21-001SMART MEDICAL SYSTEMS, LTD.
K060235ENDO-EASE ENDOSCOPIC OVERTUBESPIRUS MEDICAL, INC.
K040048FUJINON DOUBLE BALLOON ENTEROSCOPY SYSTEMFUJINON, INC.
K031256XSIF-1TQ140A SMALL INTESTINAL VIDEOSCOPEOLYMPUS OPTO-ELECTRONICS CO., LTD.
K993704GASTRO-INTESTINAL SYSTEM EN-410WMFUJINON, INC.
K841396TRANSFER TROLLEYSETMA, INC.
K840722ENTEROSCOPETRIMEDYNE, INC.
K810757I.V. ADMINISTRATION SETAMERICAN MCGAW

Global Unique Device Identification Database

00858641006208Enteroscope And Accessories
04953170365478Enteroscope and accessories
04953170339943Enteroscope and accessories
04953170331145Enteroscope and accessories
04953170305757Enteroscope and accessories
04953170303043Enteroscope and accessories
04953170239564Enteroscope and accessories
04953170239533Enteroscope and accessories
04953170237461Enteroscope and accessories
04953170237423Enteroscope and accessories
04953170077739Enteroscope and accessories
04547410332100Enteroscope and accessories
04547410332094Enteroscope and accessories
04547410332063Enteroscope and accessories
04547410331646Enteroscope and accessories

Maude Adverse Events

UNKNOWNUNKNOWN2020-03-26
EVIS EXERA II SMALL INTESTINAL VIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-18
EVIS EXERA II SMALL INTESTINAL VIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-18
SIF-Y0004OLYMPUS MEDICAL SYSTEMS CORP.2020-01-16
SIF-Y0015OLYMPUS MEDICAL SYSTEMS CORP.2020-01-16
EVIS LUCERA SMALL INTESTINAL VIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2019-12-12
EVIS EXERA II SMALL INTESTINAL VIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2019-11-17
FUJIFILM DOUBLE BALLOON ENDOSCOPE EI-580BTFUJIFILM CORPORATION2019-10-25
FUJIFILM DOUBLE BALLOON ENDOSCOPE EI-580BTFUJIFILM CORPORATION2019-10-25
EVIS SMALL INTESTINAL VIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2019-10-24
EVIS EXERA II SMALL INTESTINAL VIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2019-08-22
EVIS LUCERA SMALL INTESTINAL VIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2019-07-11
EVIS LUCERA SMALL INTESTINAL VIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2019-07-11
EVIS LUCERA SMALL INTESTINAL VIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2019-07-11
EVIS LUCERA ELITE SMALL INTESTINALVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2019-06-25
EVIS LUCERA ELITE SMALL INTESTINALVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2019-06-25
EVIS LUCERA ELITE SMALL INTESTINALVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2019-06-24
EVIS LUCERA ELITE SMALL INTESTINALVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2019-06-24
EVIS LUCERA ELITE SMALL INTESTINALVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2019-06-24
EVIS LUCERA ELITE SMALL INTESTINALVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2019-06-24
EVIS LUCERA ELITE SMALL INTESTINALVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2019-06-24
EVIS LUCERA ELITE SMALL INTESTINALVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2019-06-24
FUJIFILM DOUBLE BALLOON ENDOSCOPE EN-580TFUJIFILM CORPORATION2019-05-09
FUJIFILM DOUBLE BALLOON ENDOSCOPE EN-580TFUJIFILM CORPORATION2019-05-09
ST-CB1OLYMPUS MEDICAL SYSTEMS CORP.2018-12-26
EVIS LUCERA ELITE SMALL INTESTINALVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2018-11-30
EVIS LUCERA SMALL INTESTINAL VIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2018-11-30
EVIS LUCERA SMALL INTESTINAL VIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2018-11-30
ST-SB1 (D)OLYMPUS MEDICAL SYSTEMS CORP.2018-11-29
SINGLE USE SPLINTING TUBEOLYMPUS MEDICAL SYSTEMS CORP.2018-11-29
SINGLE USE SPLINTING TUBEOLYMPUS MEDICAL SYSTEMS CORP.2018-11-29
EVIS LUCERA ELITE SMALL INTESTINALVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2018-11-29
EVIS LUCERA SMALL INTESTINAL VIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2018-11-29
EVIS LUCERA SMALL INTESTINAL VIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2018-11-29
EVIS LUCERA ELITE SMALL INTESTINALVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2018-11-29
EVIS EXERA II SMALL INTESTINAL VIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2018-11-06
EVIS LUCERA ELITE SMALL INTESTINALVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2018-10-31
EVIS EXERA II SMALL INTESTINAL VIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2018-10-09
EVIS LUCERA ELITE SMALL INTESTINALVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2018-08-07
EN-450T5/WFUJIFILM CORPORATION2018-06-22
EI-530BFUJIFILM CORPORATION2018-06-22
EI-530B OR EI-580BTFUJIFILM CORPORATION2018-06-22
UNKNOWNOLYMPUS MEDICAL SYSTEMS CORP.2018-06-08
UNKNOWNOLYMPUS MEDICAL SYSTEMS CORP.2018-06-08
UNKNOWNOLYMPUS MEDICAL SYSTEMS CORP.2018-06-07
UNKNOWNOLYMPUS MEDICAL SYSTEMS CORP.2018-06-07
UNKNOWNOLYMPUS MEDICAL SYSTEMS CORP.2018-06-07
UNKNOWNOLYMPUS MEDICAL SYSTEMS CORP.2018-06-07
EVIS LUCERA ELITE SMALL INTESTINALVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2018-06-07
UNKNOWNOLYMPUS MEDICAL SYSTEMS CORP.2018-06-07
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