Technomed Europe
FDA Regulatory Profile
Technomed Europe appears in FDA public data with 3 recalls, 13 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-3131-2024, Class II) was initiated on July 25, 2024. Its most recent 510(k) clearance was granted on May 7, 2026.
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 13
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-3131-2024 | Class II | NEUROSIGN Disposable Stimulating Dissector, REF 5888-00 | July 25, 2024 |
| Z-1737-2022 | Class II | Disposable Subdermal Needle Electrode, Pt/lr, 12 x 0.40mm, product number TE/S46/638, 25 needles per | August 9, 2022 |
| Z-0465-2022 | Class II | Disposable Subdermal Needle Electrode, Corkscrew, Single Use, Sterile; Model Numbers TE/S50715-001-C | December 8, 2021 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K254183 | MR Conditional Cup Electrodes | May 7, 2026 |
| K253581 | Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001); Disposable Concentric Needle E | March 15, 2026 |
| K241045 | Disposable Subdermal Needle Electrode, Corkscrew | December 11, 2024 |
| K130136 | DISPOSABLE AND REUSABLE CONCENTRIC NEEDLE ELECTRODES,DISPOSABLE AND REUSABLE SUBDERMAL NEEDLE ELECTR | July 19, 2013 |
| K121257 | LARYNGEAL ELECTRODE | August 28, 2012 |
| K110422 | SURGICAL STIMULATORS | May 26, 2011 |
| K073532 | DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES | May 1, 2008 |
| K072016 | CUP ELECTRODES, GOLD, REUSABLE, SILVER, REUSABLE; CUP ELECTRODES SILVER/SILVER CHLORIDE REUSABLE | October 19, 2007 |
| K063729 | DISPOSABLE PEDICLE SCREW PROBE, MODEL 3603-00 | August 21, 2007 |
| K062437 | DISPOSABLE HYPODERMIC EMG NEEDLE ELECTRODE TECHNOMED EUROPE VERSION AND PRIVATE LABELED | February 16, 2007 |
| K050325 | DISPOSABLE CONCENTRIC PROBE, DISPOSABLE BIPOLAR PROBE, DISPOSABLE MONOPOLAR PROBE | May 5, 2005 |
| K042375 | SMK, CX, CXE, RCN | October 26, 2004 |
| K990015 | ELECTRODE NEEDLES | May 27, 1999 |