Electrode, Needle, Diagnostic Electromyograph
Physical Medicine · 21 CFR 890.1385
Recent MDR events
150 adverse event reports on file
- TECHNOMED EUROPENov 21, 2025MalfunctionTechnomed Europe9710376-2025-00002
- TECA INJECTION NEEDLESAug 15, 2025MalfunctionNatus Manufacturing Limited3005581270-2025-00001
- TECHNOMED EUROPEJul 23, 2025MalfunctionTechnomed Europe9710376-2025-00001
- TECA CONCENTRIC NEEDLESDec 10, 2024MalfunctionNatus Manufacturing Limited3005581270-2024-00008
- TECA CONCENTRIC NEEDLESDec 10, 2024MalfunctionNatus Manufacturing Limited3005581270-2024-00009
- TECA® DISP DMN NEEDLE ELECTRODE, 1"(25MM)X0.36MMOct 30, 2024MalfunctionNatus Manufacturing Limited3005581270-2024-00007
- DANTEC DCN DISP NEEDLE ELECTRODE,1.5"(37MM)X0.46MMOct 22, 2024MalfunctionNatus Manufacturing Limited3005581270-2024-00006
- DANTEC DCN DISP NEEDLE ELECTRODE,1.5"(37MM)X0.46MMOct 4, 2024MalfunctionNatus Manufacturing Limited3005581270-2024-00004
- DANTEC DCN DISP NEEDLE ELECTRODE, 2"(50MM)X0.46MMOct 4, 2024MalfunctionNatus Manufacturing Limited3005581270-2024-00005
- VALUE LINE DCN, DISPOSABLE CONCENTRIC NEEDLE ELECTRODEAug 26, 2024MalfunctionNatus Manufacturing Limited3005581270-2024-00003
Event type breakdown
Recalls
2 recall events for this product code
- Chalgren Enterprises IncTerminatedSep 21, 2010
Disposable Detachable Monopolar Needle Electrode for electromyograph model number 110-725, for Physician use, manufactured by Chalgren Enterprises Inc., Gilroy,
Sterility Compromised-- Investigation found that individual packaging seals were separating, which may compromise sterility.
Z-2446-2010 · View FDA record ↗ - Technomed EuropeTerminatedUnknown
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.
Z-1737-2022 · View FDA record ↗
Registered firms
94 firms currently registered for this product code
Sanicure Bv
SCHIPHOL Noord-Holland, NL
Covidien
- Santo Domingo, DO
Rhythmlink International, Llc
Columbia, SC, US
Technomed Asia, Pt.
Bandung Jawa Barat, ID
Technomed Europe
Kerkrade Limburg, NL
Cbr Enterprise Limited
Hong Kong, HK
Pine Moon Electronics Co., Ltd.
SHENZHEN CITY Guangdong, CN
Sterigenics Belgium Petit Rechain S.a.
Verviers Liege, BE
Veenak International Limited
BIRMINGHAM, GB
Synergy Health Westport Ltd
Westport Mayo, IE
Nihon Kohden Corporation - Eastern Japan Logistics Center
Sakado City Saitama, JP
Natus Neurology Incorporated
Middleton, WI, US
Ambu Sdn.bhd.
PENANG Pulau Pinang, MY
Sterigenics U.s. Llc
Hayward, CA, US
510(k) clearances
43 clearances for this product code
- Technomed EuropeMar 15, 2026
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)
- Natus Manufacturing LimitedJun 29, 2018
K173815 · Allergan Botox Needle Electrode
- Natus Manufacturing LimitedMar 2, 2017
K161430 · Myoject Luer Lock Needle Electrode
- Bio Protech, Inc.Jun 3, 2016
K152984 · Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes
- Natus Manufacturing LimitedAug 28, 2015
K143433 · Dantec DCN Disposable Concentric Needle Electrodes-25mm, Dantec DCN Disposable Concentric Needle Electrodes-37mm, Dantec DCN Disposable Concentric Needle Electrodes-50mm, Dantec DCN Disposable Concentric Needle Electrodes-75mm
- Rhythmlink International, LLCJun 22, 2012
K120342 · EMG RECORDING ELECTRODE ASSEMBLY
- Carefusion 209, Inc.Aug 12, 2011
K112034 · TECA ELITE DISPOSABLE CONCENTRIC NEEDLES
- Carefusion 209, Inc.Jun 17, 2011
K111131 · TECA (TM) ELITE DISPOSABLE MONOPOLAR NEEDLES