Home › Device types › IKT
Electrode, Needle, Diagnostic Electromyograph
FDA product code IKT · Class 2 · Physical Medicine
906
Registered devices
150
Adverse events
2
Recalls
43
510(k) clearances
Devices with this code
Disposable EMG needle electrodes — SPES MEDICA SPADisposable EMG needle electrodes — SPES MEDICA SPABIONEN — BIONEN SAS DI BARBARA NENCIONI & C.AD-TECH — Technomed Engineering B.V.Chalgren — CHALGREN ENTERPRISESMediMax Tech — MEDIMAX TECH INC.Ambu — Technomed Engineering B.V.Technomed Europe — Technomed Engineering B.V.Rhythmlink® — RHYTHMLINK INTERNATIONAL, LLCBio Protech — BIO PROTECH USA, INC.CNS - Premier Vision — Technomed Engineering B.V.Bio Protech — BIO PROTECH USA, INC.Chalgren — CHALGREN ENTERPRISESNATUS NEUROLOGY — NATUS NEUROLOGY INCORPORATEDNeuroline SubdermalNeurology Needle Electrodes — Ambu A/SNeuroline Twisted Pair SubdermalNeurology Needle Electrodes — Ambu A/SAmbu — Technomed Engineering B.V.Disposable EMG needle electrodes — SPES MEDICA SPATechnomed Europe — Technomed Engineering B.V.Neuroguard — Technomed Engineering B.V.Technomed Europe — Technomed Engineering B.V.Cadwell — Technomed Engineering B.V.Technomed Europe — Technomed Engineering B.V.Technomed Europe — Technomed Engineering B.V.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-08-09 | Technomed Europe | 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. |
| 2007-04-12 | Chalgren Enterprises Inc | Sterility Compromised-- Investigation found that individual packaging seals were separating, which may compromise sterility. |
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