Company ยท US
Fresenius Medical Care North America, Design Cente
FDA 510(k) clearances and medical device recalls filed under this name, 2010 to 2013. Name variants (Inc, Corp, punctuation) are merged.
5510(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 |
|---|---|---|---|
| Sep 9, 2013 | K123630 | FRESENIUS LIBERTY CYCLER Fresenius Medical Care North America, Design Cente | FKX |
| Jan 17, 2013 | K121421 | FRESENIUS 2008K HOME HEMODIALYSIS MACHINE WITH WIRELESS WETNESS DETECTOR (WETALERT) Fresenius Medical Care North America, Design Cente | ONW |
| Jun 15, 2012 | K120823 | BVM HEMODIALYSIS BLOOD TUBING SET WITH ATTACHED PRIMING SET AND TRANSDUCER PROTECTORS Fresenius Medical Care North America, Design Cente | FJK |
| Mar 6, 2012 | K120505 | FRESENIUS 2008T HEMODIALYSIS MACHINE Fresenius Medical Care North America, Design Cente | KDI |
| Dec 21, 2010 | K101715 | FRESENIUS 2008T HEMODIALYSIS MACHINE MODEL 190573 Fresenius Medical Care North America, Design Cente | KDI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||