Home › Device types › GXD
Generator, Lesion, Radiofrequency
FDA product code GXD · Class 2 · Neurology
284
Registered devices
1,812
Adverse events
7
Recalls
37
510(k) clearances
Devices with this code
NA — BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNA — BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNA — Stryker Leibinger GmbH & Co. KGNA — Stryker Leibinger GmbH & Co. KGNA — ST. JUDE MEDICAL, INC.NA — BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNA — Stryker Leibinger GmbH & Co. KGOneRF Ablation System — NEUROONE MEDICAL TECHNOLOGIES CORPORATIONNA — Stryker Leibinger GmbH & Co. KGNA — BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNA — BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNA — BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNA — Stryker Leibinger GmbH & Co. KGNA — BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNA — BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNA — ST. JUDE MEDICAL, INC.IonicRF™ — ST. JUDE MEDICAL, INC.NT1100™ — ST. JUDE MEDICAL, INC.NA — Stryker Leibinger GmbH & Co. KGNA — Stryker Leibinger GmbH & Co. KGSMK™ — ST. JUDE MEDICAL, INC.NA — BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNA — BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNA — BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-09-28 | Abbott | Certain NT2000iX RF generators were serviced using a tool that was subsequently found to be out of tolerance and therefore may not have provided accurate result |
| 2023-08-01 | Avanos Medical, Inc. | Avanos has received an increase in complaints from customers for COOLIEF RF Generators producing F100 and F101 faults. |
| 2021-04-22 | Abbott Laboratories Inc. (St Jude Medical) | Potential capacitor failure which typically manifests as in inability to provide output on one or more channels. In some instances, users reported a charring/s |
| 2019-10-14 | Abbott Medical | Affected lots were manufactured with the protective release liner in an incorrect orientation. When attempting to remove this disposable release liner, a clear |
| 2016-10-11 | Stryker Instruments Div. of Stryker Corporation | Stryker Instruments is voluntarily recalling the Care Instructions/Instructions for Use packaged with the Radiofrequency (RF) MultiGen Generator, because the in |
| 2013-10-09 | Neurotherm, Inc. | NT2000iX software shipped with the international setting turned on. The international settings include access to Corodotomy, Bi-Polar, and No Temperature modes |
| 2010-04-13 | Stryker Instruments Div. of Stryker Corporation | This recall is related to the Electri-cord recall. There is a risk when excessive force is applied to the plugs, a fracture can develop on the prongs inside the |
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