Fujinon, Inc.
Country not established
- Devices
- 30
- FDA recalls
- 3
At a glance
Market reach
- United States
- FDA recalls
What Fujinon, Inc. makes
Fujinon, Inc. manufactures endoscopic and laparoscopic medical devices, including ultrasonic endoscopes and processors such as the EG-530UR, EG-530UT, and SU-700 models, as well as video laparoscopes modified for general and thoracoscopic use. The company also produces double balloon enteroscopy systems, bronchoscopes, colonoscopes (including the G5 series models EC-450HL5 and EC-250HL5), and endoscopic ultrasound (EVL-F and EDU) systems for diagnostic and therapeutic procedures.
These devices are classified as Class I and Class II medical devices and are listed in the FDA’s 510(k) registry. Fujinon, Inc. is based in the United States.
Catalogue
Search and filter all 30 devicesFDA recalls
FDA recall records list 3 recalls initiated by Fujinon, Inc., the earliest on 2006-03-27 and the most recent on 2013-07-31. By recorded status: 3 terminated. The reasons filed fall into these groups: manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2013
- 31 Jul 2013 Z-0112-2014 Class II Terminated A limited number of endoscopes were shipped to FMSU-ESD with a manufacturing defect which included missing set screws used to more securely attach the Forceps Inlet (biopsy inlet port) to the endoscope.
2011
- 7 Jan 2011 Z-1067-2011 Unclassified (pre-2012) Terminated The FICE feature installed in video endoscopic processors is being disabled since this feature should have been reviewed under the premarket notification/510k process.
2006
- 27 Mar 2006 Z-0708-06 Unclassified (pre-2012) Terminated Colonoscope insertion tube is not bending properly and is stiff.
Full distribution text
- 27 Mar 2006 Z-0708-06 Unclassified (pre-2012) Terminated Colonoscope insertion tube is not bending properly and is stiff.
Frequently asked questions
How many devices does Fujinon, Inc. have in the registry?
The registry currently lists 30 devices for Fujinon, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Fujinon, Inc.'s devices?
Among its 30 most recently registered devices, Fujinon, Inc. has devices listed in FDA 510(k) (30 devices).
What risk classes do Fujinon, Inc.'s devices fall under?
Among its 30 most recently registered devices, the classes recorded for Fujinon, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Fujinon, Inc.?
FDA recall records list 3 recalls initiated by Fujinon, Inc., the most recent initiated on 2013-07-31. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Fujinon, Inc. in the registry?
The most recently registered devices listed for Fujinon, Inc. include FUJINON ULTRASONIC ENDOSCOPE AND PROCESSOR, MODELS EG-530UR, EG-530UT AND SU-700, FUJINON DOUBLE BALLOON ENTEROSCOPY SYSTEM, FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EG-530UR2 AND EG-530UT2 and LAPAROSCOPIC LYMPHADENECTOMY.