Technomed Europe
Kerkrade Limburg, NL
TECHNOMED EUROPE appears in FDA device records in Kerkrade Limburg, NL. FDA records list 13 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 13 510(k) clearances for Technomed Europe between 1999 and 2026. The busiest year on record is 2007, with 3. The most recent is 2026, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1999 | 1 |
| 2004 | 1 |
| 2005 | 1 |
| 2007 | 3 |
| 2008 | 1 |
| 2011 | 1 |
| 2012 | 1 |
| 2013 | 1 |
| 2024 | 1 |
| 2026 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K254183 | MR Conditional Cup Electrodes | GXY | Substantially Equivalent | |
| 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 | Substantially Equivalent | |
| K241045 | Disposable Subdermal Needle Electrode, Corkscrew | GXZ | Substantially Equivalent | |
| K130136 | DISPOSABLE AND REUSABLE CONCENTRIC NEEDLE ELECTRODES,DISPOSABLE AND REUSABLE SUBDERMAL NEEDLE ELECTRODES, | GXZ | Substantially Equivalent | |
| K121257 | LARYNGEAL ELECTRODE | ETN | Substantially Equivalent | |
| K110422 | SURGICAL STIMULATORS | ETN | Substantially Equivalent | |
| K073532 | DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES | GXY | Substantially Equivalent | |
| K072016 | CUP ELECTRODES, GOLD, REUSABLE, SILVER, REUSABLE; CUP ELECTRODES SILVER/SILVER CHLORIDE REUSABLE | GXY | Substantially Equivalent | |
| K063729 | DISPOSABLE PEDICLE SCREW PROBE, MODEL 3603-00 | GXZ | Substantially Equivalent | |
| K062437 | DISPOSABLE HYPODERMIC EMG NEEDLE ELECTRODE TECHNOMED EUROPE VERSION AND PRIVATE LABELED | IKT | Substantially Equivalent | |
| K050325 | DISPOSABLE CONCENTRIC PROBE, DISPOSABLE BIPOLAR PROBE, DISPOSABLE MONOPOLAR PROBE | GXZ | Substantially Equivalent | |
| K042375 | SMK, CX, CXE, RCN | GXI | Substantially Equivalent | |
| K990015 | ELECTRODE NEEDLES | IKT | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9710376 | 3001450493 | TECHNOMED EUROPE | Wiebachstraat 25a, Kerkrade Limburg 6466 NG NL | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-3131-2024 | NEUROSIGN Disposable Stimulating Dissector, REF 5888-00 | Product has have presence of brown discoloration or substance on the hinge area of the device | Class II | Open, Classified | |
| Z-1737-2022 | Disposable Subdermal Needle Electrode, Pt/lr, 12 x 0.40mm, product number TE/S46/638, 25 needles per package, sterile. | Burns of varying degrees can occur to patients with electrodes left in while in the MRI scanner as a result of inadequate safety information in the IFU. | Class II | Terminated | |
| Z-0465-2022 | Disposable Subdermal Needle Electrode, Corkscrew, Single Use, Sterile; Model Numbers TE/S50715-001-C, TE/S50725-001C, and TE/S50715-001. | There is a high risk of the blue hub detaching from the corkscrew needle, resulting the the needle remaining in the patient's scalp. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain