Te ME NA S.A.R.L.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Te ME NA S.A.R.L.” (first 1999, latest 2001), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 576 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 |
|---|---|---|---|
| BSO | Catheter, Conduction, Anesthetic | 1 | 1 |
| BSP | Needle, Conduction, Anesthetic (W/Wo Introducer) | 1 | 1 |
| BXN | Stimulator, Nerve, Battery-Powered | 1 | 1 |
| FMF | Syringe, Piston | 1 | 1 |
| GXZ | Electrode, Needle | 1 | 1 |
Review panels
- Anesthesiology (3)
- General Hospital (1)
- Neurology (1)
Most recent Te ME NA S.A.R.L. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K990323 | TE ME NA POLYSTIM NERVE STIMILATOR | BXN | 2001-09-28 | 969 |
| K002405 | SPINAL EPIDURAL NEEDLES | BSP | 2001-06-01 | 298 |
| K991259 | TE ME NA EPIDURAL CATHETER | BSO | 2001-02-21 | 680 |
| K990100 | POLYMEDIC UPA NERVE STIMULATION NEEDLE; POLYMEDIC UPC NERVE STIMULATION NEEDLE | GXZ | 2000-08-02 | 576 |
| K990020 | TE ME NA LOSS OF RESISTANCE SYRINGE, 10CC | FMF | 1999-06-24 | 171 |
Recalls
openFDA lists no recalls under a recalling firm named Te ME NA S.A.R.L..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Te ME NA S.A.R.L.?
FDA lists 5 510(k) clearances under the applicant name “Te ME NA S.A.R.L.” (first 1999, latest 2001), across 5 product codes in 3 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 Te ME NA S.A.R.L.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Te ME NA S.A.R.L. is 576 days.
Which FDA product codes appear under Te ME NA S.A.R.L.?
The most frequent FDA product codes under this applicant name are BSO (Catheter, Conduction, Anesthetic, 1); BSP (Needle, Conduction, Anesthetic (W/Wo Introducer), 1); BXN (Stimulator, Nerve, Battery-Powered, 1).
Next steps
- See all 5 Te ME NA S.A.R.L. clearances with predicates and recalls
- Run predicate analysis for product code BSO, Te ME NA S.A.R.L.'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.