Company ยท US
Isotis NV
FDA 510(k) clearances and medical device recalls filed under this name, 2000 to 2007. 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 |
|---|---|---|---|
| Aug 15, 2007 | K061880 | ACCELI DBM FAMILY PRODUCTS, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CC Isotis NV, NL | MQV |
| Mar 29, 2006 | K060332 | ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY Isotis NV, NL | NUN |
| Mar 27, 2006 | K060306 | ACCELL CONNEXUS DEMINERALIZED BONE MATRIX PUTTY Isotis NV | NUN |
| Aug 20, 2004 | K031813 | OSSATURA DENTAL Isotis NV | LYC |
| Jul 16, 2004 | K041344 | OPEN BORE SYRINGE Isotis NV, NL | FMF |
| May 20, 2003 | K030131 | OSSATURA BCP BONE VOID FILLER Isotis NV | MQV |
| Apr 20, 2001 | K010840 | SYNPLUG Isotis NV | LZN |
| May 4, 2000 | K000587 | SHUTTLE STOP Isotis NV | LZN |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||