Medical Device Manufacturer · US , Cincinnati , OH

Mallinckrodt Inc., Liebel-Flarsheim Business - FDA 510(k) Cleared Dev...

8 submissions · 8 cleared · Since 1997

Recent clearances: OPTISTAR MR INJECTOR SYSTEM

8

Total

8

Cleared

0

Denied

FDA 510(k) Regulatory Record - Mallinckrodt Inc., Liebel-Flarsheim Business Cardiovascular ✕

8 devices

1-8 of 8

Cleared Jan 22, 2009

SYRINGE WITH HANDI-FIL

Cardiovascular · 169d

Cleared May 07, 2008

OPTISTAR ELITE INJECTION SYSTEM

Cardiovascular · 139d

Cleared Apr 27, 2007

OPTIVANTAGE DH INJECTOR SYSTEM WITH ENHANCED COMMUNICATION

Cardiovascular · 158d

Cleared Nov 30, 2004

OPTIV ANTAGE DH POWER INJECTION SYSTEM

Cardiovascular · 57d

Cleared Jul 11, 2003

Cardiovascular · 74d

Cleared Jul 26, 2002

ELPH INJECTION SYSTEM

Cardiovascular · 25d

Cleared Dec 06, 1999

OPTISTAR MR INJECTOR SYSTEM

Cardiovascular · 385d

Cleared Sep 23, 1997

ANGIOMAT ILLUMENA

Cardiovascular · 412d