International Medical Devices Database

Manufacturer Address
Fujifilm Medical Systems U.S.A., Inc., 10 Highpoint Dr, Wayne NJ 07470-7431
Manufacturer Parent Company (2017)
FUJIFILM Holdings Corp.
Source
USFDA
13 Events

13 devices in the database

Device Recall FUJINON ED530XT

Model / Serial
All lots/serial numbers
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide
Product Description
FUJINON ED-530XT. || This device is intended for the visualization of the duodenum and upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.

Device Recall Fujifilm

Model / Serial
will be entered.
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
US Nationwide Distribution
Product Description
Fujifilm Endoscope || Models || ED-250XL5 || ED-250XT5 || ED-450XT5 || ED-450XL5 || Product Usage: || This product is a medical endoscope for the duodenum and upper GI tract. It is intended for observation, diagnosis, and endoscopic treatment of the esophagus, stomach and duodenum. This product is not used for any other purposes.

Device Recall Fujifilm

Model / Serial
For Manual Code 202B1259902B, 140417-3.0-DT-US2 - 157 manuals were distributed For Manual Code 202B1237697D, 140408-5.0-DT-US2 - 103 manuals were distributed
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
US Nationwide Distribution
Product Description
Fujifilm Endoscope || Model ED-530XT || Product Usage: || This product is a medical endoscope for the duodenum and upper GI tract. It is intended for observation, diagnosis, and endoscopic treatment of the esophagus, stomach and duodenum. This product is not used for any other purposes.

Device Recall Fujifilm

Model / Serial
1U881A131 1U88A1A145 3U881A005
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
US Distribution to : AL, HI and MO
Product Description
Ultrasonic Endoscope || Model Number EG-530UT || A flexible ultrasonic endoscope intended to provide ultrasonic images of submucosal and peripheral organs

Device Recall Fujifilm Endoscope ED450XL5

Model / Serial
All distribution dates :3/2003-4/2016
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution.
Product Description
Endoscope || ED-450XL5 || Operation Manual: Cleaning, Disinfection and Storage

8 more

2 manufacturers with a similar name

Learn more about the data here

Fujifilm Medical Systems U.S.A., Inc.

Manufacturer Address
Fujifilm Medical Systems U.S.A., Inc., 419 West Ave, Stamford CT 06902-6343
Manufacturer Parent Company (2017)
FUJIFILM Holdings Corp.
Source
USFDA

FUJIFILM Medical Systems U.S.A., Inc.

Manufacturer Parent Company (2017)
FUJIFILM Holdings Corp.
Source
ORMPMDBP

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Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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