Medical Device Manufacturer · US , Frazer , PA

Animas Corp. - FDA 510(k) Cleared Devices

10 submissions · 10 cleared · Since 2000

10

Total

10

Cleared

0

Denied

FDA 510(k) Regulatory Record - Animas Corp. General Hospital ✕

10 devices

1-10 of 10

Cleared Jun 24, 2008

SYMPHONY GLUCOSE MANAGEMENT SYSTEM

General Hospital · 110d

Cleared May 15, 2008

EZ MANAGER MAX DIABETES MANAGEMENT SOFTWARE

General Hospital · 73d

Cleared Mar 30, 2007

EZMANAGER MAX DIABETES MANAGEMENT SOFTWARE

General Hospital · 109d

Cleared Dec 10, 2004

ANIMAS MODEL IR1250 INSULIN INFUSION PUMP

General Hospital · 53d

Cleared Oct 16, 2003

MODEL IR 1200 INSULIN PUMP

General Hospital · 86d

Cleared Jun 05, 2003

General Hospital · 317d

Cleared Jun 04, 2002

ANIMUS EZSERTER INFUSION SET INSERTER

General Hospital · 12d

Cleared May 29, 2002

MODEL R1000 IR INSULIN PUMP, EZLINK SOFTWARE, SERMON SOFTWARE, R1000 IR...

General Hospital · 23d

Cleared Aug 27, 2001

EZ SET INFUSION SET

General Hospital · 11d

Cleared Feb 10, 2000

R1000 SERIES INSULIN PUMP

General Hospital · 140d