Teknimed, S.A.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Teknimed, S.A.” (first 2003, latest 2011), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 147 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MQV | Filler, Bone Void, Calcium Compound | 4 | 4 |
| NDN | Cement, Bone, Vertebroplasty | 4 | 4 |
| LYC | Bone Grafting Material, Synthetic | 2 | 2 |
| LZN | Cement Obturator | 1 | 1 |
Review panels
- Orthopedic (9)
- Dental (2)
Most recent Teknimed, S.A. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K103433 | F20 | NDN | 2011-01-03 | 40 |
| K090435 | VERTECEM | NDN | 2009-12-21 | 305 |
| K083005 | NANGEL | LYC | 2009-03-04 | 147 |
| K080873 | OPACITY + BONE CEMENT | NDN | 2008-08-28 | 150 |
| K062102 | ODONCER | LYC | 2007-04-16 | 266 |
| K043593 | SPINE-FIX BIOMIMETIC BONE CEMENT | NDN | 2006-03-17 | 443 |
| K042911 | CEMENTEK LV | MQV | 2004-12-27 | 67 |
| K041493 | CEMENTEK | MQV | 2004-08-19 | 76 |
| K040669 | CERAFORM BONE VOID FILLER | MQV | 2004-05-03 | 49 |
| K031826 | TRIHA + | MQV | 2003-11-28 | 168 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Teknimed, S.A..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Teknimed Sas (3 510(k)s)
- Teknimed (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Teknimed, S.A.?
FDA lists 11 510(k) clearances under the applicant name “Teknimed, S.A.” (first 2003, latest 2011), across 4 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Teknimed, S.A.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Teknimed, S.A. is 147 days.
Which FDA product codes appear under Teknimed, S.A.?
The most frequent FDA product codes under this applicant name are MQV (Filler, Bone Void, Calcium Compound, 4); NDN (Cement, Bone, Vertebroplasty, 4); LYC (Bone Grafting Material, Synthetic, 2).
Next steps
- See all 11 Teknimed, S.A. clearances with predicates and recalls
- Run predicate analysis for product code MQV, Teknimed, S.A.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.