Medical Device Manufacturer · US , Mchenry , IL

E-Z-Em, Inc. - FDA 510(k) Cleared Devices

56 submissions · 56 cleared · Since 1977

56

Total

56

Cleared

0

Denied

FDA 510(k) Regulatory Record - E-Z-Em, Inc. Radiology ✕

13 devices

1-12 of 13

Cleared Jun 13, 2007

MODIFICATION TO EMPOWER CT/CTA INJECTOR SYSTEM, MODELS 9800/9900 PRODUCT SERIES

Radiology · 27d

Cleared Nov 02, 2006

EMPOWER CT/CTA INJECTOR SYSTEM, MODEL 9800/9900

Radiology · 31d

Cleared Jun 19, 2003

EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825

Radiology · 30d

Cleared May 16, 2001

E-Z EM PERCUPUMP 2001 CT INJECTOR

Radiology · 30d

Cleared Jan 27, 1998

PERCUPUMP II WITH EDA

Radiology · 47d

Cleared Jan 23, 1997

PERCUPUMP II WITH EDA

Radiology · 255d

Cleared Mar 21, 1995

Radiology · 692d

Cleared Apr 27, 1992

SONO-VU US(TM), MODIFICATION

Radiology · 89d

Cleared Jun 24, 1991

Radiology · 258d

Cleared Jan 16, 1987

Radiology · 80d

Cleared Feb 02, 1979

Radiology · 80d

Cleared Sep 14, 1978

VAC-U-PAC KIDNEY CASSETTE

Radiology · 8d