Integrated Medical Systems Inc

FDA Regulatory Profile

Summary

Total Recalls
22
510(k) Clearances
5
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0894-2016Class IIOlympus, Model No. GIF-Q180,flexible scope, large diameter, video gastroscopeJanuary 20, 2016
Z-0890-2016Class IIOlympus, Model No. GIF-H180, flexible scope, large diameter, video gastroscopeJanuary 20, 2016
Z-0904-2016Class IIOlympus, Model No. GIF-Q160, flexible scope, large diameter, video gastroscopeJanuary 20, 2016
Z-0896-2016Class IIOlympus, Model No. CF-Q180AL, flexible scope, large diameter, video colonoscopeJanuary 20, 2016
Z-0902-2016Class IIOlympus, Model No. CF-Q160AL, flexible scope, large diameter, video colonoscopeJanuary 20, 2016
Z-0893-2016Class IIOlympus, Model No. GIF-H180J, flexible scope, large diameter, video gastroscopeJanuary 20, 2016
Z-0908-2016Class IIOlympus, Model No. PCF-H190L, flexible scope, large diameter, video pediatric colonoscopeJanuary 20, 2016
Z-0901-2016Class IIOlympus, Model No. PCF-Q180AL, flexible scope, large diameter, video colonoscopeJanuary 20, 2016
Z-0905-2016Class IIOlympus, Model No. TJF-160F, flexible scope, large diameter, video duodenoscopeJanuary 20, 2016
Z-0889-2016Class IIOlympus, Model No. PCF-H180AL, flexible scope, large diameter, video pediatric colonoscopeJanuary 20, 2016
Z-0899-2016Class IIOlympus, Model No. GIF-Q140, flexible scope, large diameter, video gastroscopeJanuary 20, 2016
Z-0910-2016Class IIOlympus, Model No. XCF-Q160ALE, flexible scope, large diameter, video colonoscopeJanuary 20, 2016
Z-0891-2016Class IIOlympus, Model No. CF-H180AL, flexible scope, large diameter, video colonoscopeJanuary 20, 2016
Z-0892-2016Class IIOlympus, Model No. GIF-160, flexible scope, large diameter, video gastroscopeJanuary 20, 2016
Z-0895-2016Class IIOlympus, Model No. GIF-XP160, flexible scope, large diameter, video gastroscopeJanuary 20, 2016
Z-0898-2016Class IIOlympus, Model No. CF-Q160L, flexible scope, large diameter, video colonoscopeJanuary 20, 2016
Z-0906-2016Class IIOlympus, Model No. GIF-XQ140, flexible scope, large diameter, video gastroscopeJanuary 20, 2016
Z-0903-2016Class IIOlympus, Model No. CF-140L, flexible scope, large diameter, video colonoscopeJanuary 20, 2016
Z-0897-2016Class IIOlympus, Model No. PCF-160AL, flexible scope, large diameter, video colonoscopeJanuary 20, 2016
Z-0900-2016Class IIOlympus, Model No. GIF-140, flexible scope, large diameter, video gastroscopeJanuary 20, 2016

Recent 510(k) Clearances

K-NumberDeviceDate
K082256LIFE SUPPORT FOR TRAUMA AND TRNSPORT (LSTAT) G6 LITESeptember 26, 2008
K902682STICK-GARD STERILE CAPSeptember 26, 1990
K895414MULTIMED (TM) PULMONARY FUNCTION TESTING SYSTEMFebruary 12, 1990
K871659IMS-2000S STRESS MONITORMay 28, 1987
K870934IMS-2000R RESTING ELECTROCARDIOGRAPHIC SYSTEMMay 6, 1987