Medical Device Manufacturer · US , Mchenry , IL

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

56 submissions · 56 cleared · Since 1977

Total

Cleared

Denied

E-Z-Em, Inc. has 56 FDA 510(k) cleared medical devices. Based in Mchenry, US.

Historical record: 56 cleared submissions from 1977 to 2007.

Browse the FDA 510(k) cleared devices submitted by E-Z-Em, Inc. Filter by specialty or product code using the sidebar.

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

56 devices

1-12 of 56

Cleared Jun 13, 2007

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

K071378 · JAK

Radiology · 27d

Cleared Apr 13, 2007

EMPOWERMR INJECTOR SYSTEM, MODEL 9730

K062449 · IZQ

Cardiovascular · 234d

Cleared Nov 02, 2006

EMPOWER CT/CTA INJECTOR SYSTEM, MODEL 9800/9900

K063029 · JAK

Radiology · 31d

Cleared Dec 27, 2005

E-Z-EM ENDOSCOPIC CO2 REGULATOR

K053008 · FCX

Gastroenterology & Urology · 62d

Cleared Jul 16, 2004

EMPOWER TRANSFER SET, (CAT. NO. 7725)

K041178 · FPK

General Hospital · 72d

Cleared Jun 19, 2003

EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825

K031571 · IZQ

Radiology · 30d

Cleared Apr 16, 2003

PROTOCO2L COLON INSUFFLATOR WITH PERFORMANCE IMPROVEMENTS, MODEL 6400

K030854 · FCX

Gastroenterology & Urology · 29d

Cleared Feb 19, 2002

PROTOCO2L INSUFFLATOR MODEL 6400

K013219 · FCX

Gastroenterology & Urology · 146d

Cleared May 16, 2001

E-Z EM PERCUPUMP 2001 CT INJECTOR

K011160 · JAK

Radiology · 30d

Cleared Jan 27, 1998

PERCUPUMP II WITH EDA

K974621 · DSB

Radiology · 47d

Cleared Jan 23, 1997

PERCUPUMP II WITH EDA

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

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