Company · US
Teknimed, S.A.
FDA 510(k) clearances and medical device recalls filed under this name, 2003 to 2024. Name variants (Inc, Corp, punctuation) are merged.
15510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 18, 2024 | K242216 | GENTAFIX® (1, 3, 3MV) Teknimed Sas, FR | MBB |
| May 12, 2023 | K230394 | EUROSCREW NG; EUROSCREW TCP NG Teknimed, FR | MAI |
| Apr 12, 2017 | K161114 | HIGH V+ Teknimed Sas, FR | NDN |
| Feb 4, 2011 | K103816 | COHESION BONE CEMENT Teknimed Sas | NDN |
| Jan 3, 2011 | K103433 | F20 Teknimed, S.A. | NDN |
| Dec 21, 2009 | K090435 | VERTECEM Teknimed, S.A. | NDN |
| Mar 4, 2009 | K083005 | NANGEL Teknimed, S.A. | LYC |
| Aug 28, 2008 | K080873 | OPACITY + BONE CEMENT Teknimed, S.A. | NDN |
| Apr 16, 2007 | K062102 | ODONCER Teknimed, S.A. | LYC |
| Mar 17, 2006 | K043593 | SPINE-FIX BIOMIMETIC BONE CEMENT Teknimed, S.A. | NDN |
| Dec 27, 2004 | K042911 | CEMENTEK LV Teknimed, S.A. | MQV |
| Aug 19, 2004 | K041493 | CEMENTEK Teknimed, S.A. | MQV |
| May 3, 2004 | K040669 | CERAFORM BONE VOID FILLER Teknimed, S.A. | MQV |
| Nov 28, 2003 | K031826 | TRIHA + Teknimed, S.A. | MQV |
| Nov 26, 2003 | K032685 | CEMSTOP CEMENT RESTRICTOR Teknimed, S.A. | LZN |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 6, 2023 | TEKNIMED SAS HIGH V+ Spinal Cement System REF T040321K Open, Classified |
NDN | K161114 |
| Feb 22, 2007 | Teknimed SA OsSatura TCP (pure tricalcium phosphate) 3mm granules packaged in glass jars, Part Numbers: 05-6010-050 5cc, 05-6010-100 10cc, 05-6010-150 15cc & 05-6010-300 30cc Terminated |
MQV | K031826 |