Company ยท NL
Technomed Europe
FDA 510(k) clearances and medical device recalls filed under this name, 1999 to 2026. Name variants (Inc, Corp, punctuation) are merged.
13510(k) clearances (2 in 12 months)
3recalls (0 in 12 months)
3recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 7, 2026 | K254183 | MR Conditional Cup Electrodes Technomed Europe, NL | GXY |
| Mar 15, 2026 | K253581 | Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001); Disposable Concentric Needle Electrode 0.40x25mm Y Technomed Europe, NL | IKT |
| Dec 11, 2024 | K241045 | Disposable Subdermal Needle Electrode, Corkscrew Technomed Europe, NL | GXZ |
| Jul 19, 2013 | K130136 | DISPOSABLE AND REUSABLE CONCENTRIC NEEDLE ELECTRODES,DISPOSABLE AND REUSABLE SUBDERMAL NEEDLE ELECTRODES, Technomed Europe, NL | GXZ |
| Aug 28, 2012 | K121257 | LARYNGEAL ELECTRODE Technomed Europe, NL | ETN |
| May 26, 2011 | K110422 | SURGICAL STIMULATORS Technomed Europe, NL | ETN |
| May 1, 2008 | K073532 | DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES Technomed Europe, NL | GXY |
| Oct 19, 2007 | K072016 | CUP ELECTRODES, GOLD, REUSABLE, SILVER, REUSABLE; CUP ELECTRODES SILVER/SILVER CHLORIDE REUSABLE Technomed Europe, NL | GXY |
| Aug 21, 2007 | K063729 | DISPOSABLE PEDICLE SCREW PROBE, MODEL 3603-00 Technomed Europe, NL | GXZ |
| Feb 16, 2007 | K062437 | DISPOSABLE HYPODERMIC EMG NEEDLE ELECTRODE TECHNOMED EUROPE VERSION AND PRIVATE LABELED Technomed Europe, NL | IKT |
| May 5, 2005 | K050325 | DISPOSABLE CONCENTRIC PROBE, DISPOSABLE BIPOLAR PROBE, DISPOSABLE MONOPOLAR PROBE Technomed Europe, NL | GXZ |
| Oct 26, 2004 | K042375 | SMK, CX, CXE, RCN Technomed Europe, NL | GXI |
| May 27, 1999 | K990015 | ELECTRODE NEEDLES Technomed Europe, NL | IKT |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 12, 2024 | Technomed Europe NEUROSIGN Disposable Stimulating Dissector, REF 5888-00 Open, Classified |
ETN | K110422 |
| Aug 9, 2022 | Technomed Europe Disposable Subdermal Needle Electrode, Pt/lr, 12 x 0.40mm, product number TE/S46/638, 25 needles per package, sterile. Terminated |
IKT | K130136 |
| Dec 8, 2021 | Technomed Europe Disposable Subdermal Needle Electrode, Corkscrew, Single Use, Sterile; Model Numbers TE/S50715-001-C, TE/S50725-001C, and TE/S50715-001. Terminated |
GXZ | K130136 |