Fujinon Inc

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
30
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0112-2014Class IIFujinon/Fujifilm Ultrasonic Endoscope Intended to provide ultrasonic images of submucosal and perJuly 31, 2013

Recent 510(k) Clearances

K-NumberDeviceDate
K120446FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EG-530UR2 AND EG-530UT2August 13, 2012
K112391FUJINON COLONOSCOPESJuly 26, 2012
K102466FUJINON EPX-4440HD DIGITAL VIDEO PROCESSORMay 25, 2011
K111243FUJINON ULTRASONIC PROCESSORMay 16, 2011
K091773FUJINON STERILE OVERTUBESAugust 7, 2009
K090116FUJINON COLONOSCOPE FOR DOUBLE BALLOON ENTERSCOPY SYSTEM MODEL, EC-450B15April 22, 2009
K063316FUJINON MODEL EG-530N TRANS NASAL INSERTIONMarch 16, 2007
K063847FUJINON ULTRASONIC ENDOSCOPE AND PROCESSOR, MODELS EG-530UR, EG-530UT AND SU-700March 1, 2007
K050907FUJINON G5 BRONCHOSCOPES, MODELS EB-470S, EB-250S, AND EB-270PMay 19, 2005
K042043FUJINON INC. G5 GASTROSCOPES, MODELS EC-450WR5, EC-250WR5November 24, 2004
K042076FUJINON G5 DUODENSCOPES; G5 DUODENOSCOPES, ED-450XT5, ED-250XT5November 18, 2004
K041903FUJINON G5 COLONOSCOPES, MODELS EC-450HL5 AND EC-250HL5November 10, 2004
K040048FUJINON DOUBLE BALLOON ENTEROSCOPY SYSTEMJune 7, 2004
K993704GASTRO-INTESTINAL SYSTEM EN-410WMFebruary 11, 2000
K983561FUJINON EVL-F VIDEO LAPROSCOPEDecember 16, 1998
K971528ENDOSCOPICALLY DELIVERALBE ULTRASOUND POINT PORBE SYSTEM (ENDOSCOPY)December 12, 1997
K954707BRONCHOSCOPENovember 22, 1995
K933544FUJINON VIDEO LAPORASCOPEApril 27, 1995
K944759200 SERIES GASTRO-INTESTINAL VIDEO SYSTEMApril 11, 1995
K933906CHOLEDOCHOSCOPE/ENDOSCOPE MODIFICATIONJuly 8, 1994