Technomed Europe: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Technomed Europe” (first 1999, latest 2026), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 135 days. Since 2017 the median was 135 days, against 125 days for all cleared 510(k)s in the same product codes. 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 | 1 | 124 |
| 2013 | 1 | 182 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 238 |
| 2025 | 0 | — |
| 2026 | 2 | 126 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Technomed Europe took a median 135 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 125 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GXZ | Electrode, Needle | 4 | 4 |
| GXY | Electrode, Cutaneous | 3 | 3 |
| IKT | Electrode, Needle, Diagnostic Electromyograph | 3 | 3 |
| ETN | Stimulator, Nerve | 2 | 2 |
| GXI | Probe, Radiofrequency Lesion | 1 | 1 |
Review panels
- Neurology (11)
- Ear, Nose and Throat (2)
Most recent Technomed Europe 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K254183 | MR Conditional Cup Electrodes | GXY | 2026-05-07 | 135 |
| K253581 | Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001); Disposable Concentric Needle Electrode 0.40x25mm Yellow (TE/B50700-002); Disposable Concentric Needle Electrode 0.30x30mm Pink (TE/B50700-006); Disposable Concentric Needle Electrode 0.45x37mm Green (TE/B50700-003); Disposable Concentric Needle Electrode 0.45x50mm Blue (TE/B50700-004); Disposable Concentric Needle Electrode 0.60x75mm Violet (TE/B50700-005) | IKT | 2026-03-15 | 118 |
| K241045 | Disposable Subdermal Needle Electrode, Corkscrew | GXZ | 2024-12-11 | 238 |
| K130136 | DISPOSABLE AND REUSABLE CONCENTRIC NEEDLE ELECTRODES,DISPOSABLE AND REUSABLE SUBDERMAL NEEDLE ELECTRODES, | GXZ | 2013-07-19 | 182 |
| K121257 | LARYNGEAL ELECTRODE | ETN | 2012-08-28 | 124 |
| K110422 | SURGICAL STIMULATORS | ETN | 2011-05-26 | 101 |
| K073532 | DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES | GXY | 2008-05-01 | 136 |
| K072016 | CUP ELECTRODES, GOLD, REUSABLE, SILVER, REUSABLE; CUP ELECTRODES SILVER/SILVER CHLORIDE REUSABLE | GXY | 2007-10-19 | 88 |
| K063729 | DISPOSABLE PEDICLE SCREW PROBE, MODEL 3603-00 | GXZ | 2007-08-21 | 249 |
| K062437 | DISPOSABLE HYPODERMIC EMG NEEDLE ELECTRODE TECHNOMED EUROPE VERSION AND PRIVATE LABELED | IKT | 2007-02-16 | 189 |
3 earlier clearances. See the full list in Caduvo.
Recalls
3 product recalls in 3 recall events; 3 initiated in the last five years. Most recent: 2024-07-25.
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.
- Technomed Medical Systems, SA (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Technomed Europe?
FDA lists 13 510(k) clearances under the applicant name “Technomed Europe” (first 1999, latest 2026), across 5 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 Technomed Europe?
The median time from FDA receipt to decision across 510(k)s cleared under the name Technomed Europe is 135 days. Since 2017: 135 days, versus 125 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Technomed Europe?
The most frequent FDA product codes under this applicant name are GXZ (Electrode, Needle, 4); GXY (Electrode, Cutaneous, 3); IKT (Electrode, Needle, Diagnostic Electromyograph, 3).
Next steps
- See all 13 Technomed Europe clearances with predicates and recalls
- Run predicate analysis for product code GXZ, Technomed Europe'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.