Maastricht-Airport, NL · 3 510(k) clearances · 3 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| GXY | Electrode, Cutaneous | Class II | Neurology | 1 | 2026-05-07 |
| IKT | Electrode, Needle, Diagnostic Electromyograph | Class II | Physical Medicine | 1 | 2026-03-15 |
| GXZ | Electrode, Needle | Class II | Neurology | 1 | 2024-12-11 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2024-07-25 | Class II | Ongoing | 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 |
| 2022-08-09 | Class II | Terminated | 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. |
| 2021-12-08 | Class II | Terminated | Z-0465-2022 | Disposable Subdermal Needle Electrode, Corkscrew, Single Use, Sterile; Model Numbers TE/S50715-001-C, TE/S50725-001C, an… | — | There is a high risk of the blue hub detaching from the corkscrew needle, resulting the the needle remaining in the patient's scalp. |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-05-07 | K254183 | MR Conditional Cup Electrodes | GXY | Class II | Neurology |
| 2026-03-15 | 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 | Class II | Physical Medicine |
| 2024-12-11 | K241045 | Disposable Subdermal Needle Electrode, Corkscrew | GXZ | Class II | Neurology |