Mallinckrodt Inc., Liebel-Flarsheim Business
Cincinnati, OH, US
Mallinckrodt Inc., Liebel-Flarsheim Business appears in FDA device records in Cincinnati, OH. FDA records list 8 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 8
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 8 510(k) clearances for Mallinckrodt Inc., Liebel-Flarsheim Business between 1997 and 2009. The busiest year on record is 1997, with 1. The most recent is 2009, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1997 | 1 |
| 1999 | 1 |
| 2002 | 1 |
| 2003 | 1 |
| 2004 | 1 |
| 2007 | 1 |
| 2008 | 1 |
| 2009 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K082212 | SYRINGE WITH HANDI-FIL | DXT | Substantially Equivalent | |
| K073592 | OPTISTAR ELITE INJECTION SYSTEM | DXT | Substantially Equivalent | |
| K063503 | OPTIVANTAGE DH INJECTOR SYSTEM WITH ENHANCED COMMUNICATION | IZQ | Substantially Equivalent | |
| K042744 | OPTIV ANTAGE DH POWER INJECTION SYSTEM | DXT | Substantially Equivalent | |
| K031339 | OPTIBOLUS | DXT | Substantially Equivalent | |
| K022116 | ELPH INJECTION SYSTEM | DXT | Substantially Equivalent | |
| K984088 | OPTISTAR MR INJECTOR SYSTEM | DXT | Substantially Equivalent | |
| K963071 | ANGIOMAT ILLUMENA | DXT | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain