E-Z-Em, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
56
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K071378MODIFICATION TO EMPOWER CT/CTA INJECTOR SYSTEM, MODELS 9800/9900 PRODUCT SERIESJune 13, 2007
K062449EMPOWERMR INJECTOR SYSTEM, MODEL 9730April 13, 2007
K063029EMPOWER CT/CTA INJECTOR SYSTEM, MODEL 9800/9900November 2, 2006
K053008E-Z-EM ENDOSCOPIC CO2 REGULATORDecember 27, 2005
K041178EMPOWER TRANSFER SET, (CAT. NO. 7725)July 16, 2004
K031571EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825June 19, 2003
K030854PROTOCO2L COLON INSUFFLATOR WITH PERFORMANCE IMPROVEMENTS, MODEL 6400April 16, 2003
K013219PROTOCO2L INSUFFLATOR MODEL 6400February 19, 2002
K011160E-Z EM PERCUPUMP 2001 CT INJECTORMay 16, 2001
K974621PERCUPUMP II WITH EDAJanuary 27, 1998
K961845PERCUPUMP II WITH EDAJanuary 23, 1997
K954926HM-CAP CONTROL PANELJanuary 30, 1996
K932055PERCUPUMP IIMarch 21, 1995
K930581E-Z-FLATEJuly 1, 1994
K911349E-Z-EM ENTEROCLYSIS CATHETER SETNovember 16, 1992
K914986GUIDE WIRES, MODIFICATIONMay 20, 1992
K914987HIGH PRESSURE CONNECTING SETS, MODIFICATIONMay 20, 1992
K914984E-Z-FLOW ANGIOGRAPHY CATHETERS, MODIFICATIONMay 20, 1992
K921738SONO-VU US(TM), MODIFICATIONApril 27, 1992
K920816PERCUGUIDE LESION MARKINGApril 21, 1992