Company ยท US
Mallinckrodt Inc., Liebel-Flarsheim Business
FDA 510(k) clearances and medical device recalls filed under this name, 1997 to 2009. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 22, 2009 | K082212 | SYRINGE WITH HANDI-FIL Mallinckrodt Inc., Liebel-Flarsheim Business | DXT |
| May 7, 2008 | K073592 | OPTISTAR ELITE INJECTION SYSTEM Mallinckrodt Inc., Liebel-Flarsheim Business | DXT |
| Apr 27, 2007 | K063503 | OPTIVANTAGE DH INJECTOR SYSTEM WITH ENHANCED COMMUNICATION Mallinckrodt Inc., Liebel-Flarsheim Business | IZQ |
| Nov 30, 2004 | K042744 | OPTIV ANTAGE DH POWER INJECTION SYSTEM Mallinckrodt Inc., Liebel-Flarsheim Business | DXT |
| Jul 11, 2003 | K031339 | OPTIBOLUS Mallinckrodt Inc., Liebel-Flarsheim Business | DXT |
| Jul 26, 2002 | K022116 | ELPH INJECTION SYSTEM Mallinckrodt Inc., Liebel-Flarsheim Business | DXT |
| Dec 6, 1999 | K984088 | OPTISTAR MR INJECTOR SYSTEM Mallinckrodt Inc., Liebel-Flarsheim Business | DXT |
| Sep 23, 1997 | K963071 | ANGIOMAT ILLUMENA Mallinckrodt Inc., Liebel-Flarsheim Business | DXT |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||