Electrode, Needle
Neurology · 21 CFR 882.1350
Recent MDR events
329 adverse event reports on file
- NIM® EMG ELECTRODEJul 22, 2026MalfunctionMedtronic Xomed Inc.1045254-2026-01022
- NIM® EMG ELECTRODEJul 15, 2026MalfunctionMedtronic Dominicana9612501-2026-01915
- NIM-ECLIPSE® PROBEJul 8, 2026MalfunctionMedtronic Xomed, Inc1045254-2026-00947
- NIM® EMG ELECTRODEJun 19, 2026MalfunctionMedtronic Xomed Inc.1045254-2026-00859
- NIM® EMG ELECTRODEJun 3, 2026MalfunctionMedtronic Dominicana9612501-2026-01521
- NIM-ECLIPSE® ELECTRODEMay 13, 2026MalfunctionMedtronic Xomed, Inc1045254-2026-00664
- NEUROGUARDApr 21, 2026InjuryTechnomed Europe9710376-2026-00003
- NIM® EMG ELECTRODEApr 3, 2026MalfunctionMedtronic Dominicana9612501-2026-00979
- NIM® EMG ELECTRODEApr 1, 2026MalfunctionMedtronic Dominicana9612501-2026-00939
- CADWELLApr 1, 2026InjuryTechnomed Europe9710376-2026-00002
Event type breakdown
Recalls
21 recall events for this product code
- Stryker Instruments Div. of Stryker CorporationTerminatedSep 3, 2010
21G x 90mm/20 Bevel Single Shot Needle, REF 55-021-090, Rx, Sterile, Distributed by: Stryker Instruments, Kalamazoo, MI.
Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective, and catheter tips may break in patients.
Z-2361-2010 · View FDA record ↗ - Stryker Instruments Div. of Stryker CorporationTerminatedSep 3, 2010
22G x 50m/20 bevel Single Shot Needle, REF 552-022-050, Rx, Sterile, Distributed by: Stryker Instruments, Kalamazoo, MI.
Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective, and catheter tips may break in patients.
Z-2362-2010 · View FDA record ↗ - Stryker Instruments Div. of Stryker CorporationTerminatedSep 3, 2010
21G x 150m/20 bevel Single Shot Needle, REF 552-021-150, Rx, Sterile, Distributed by: Stryker Instruments, Kalamazoo, MI.
Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective, and catheter tips may break in patients.
Z-2363-2010 · View FDA record ↗ - Stryker Instruments Div. of Stryker CorporationTerminatedSep 3, 2010
22G x 70mm/20 bevel Single Shot Needle, REF 552-022-70, Rx, Sterile, Distributed by: Stryker Instruments, Kalamazoo, MI.
Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective, and catheter tips may break in patients.
Z-2364-2010 · View FDA record ↗ - Stryker Instruments Div. of Stryker CorporationTerminatedSep 3, 2010
24G x 25mm/20 bevel Single Shot Needle, REF 552-024-025, Rx, Sterile, Distributed by: Stryker Instruments, Kalamazoo, MI.
Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective, and catheter tips may break in patients.
Z-2365-2010 · View FDA record ↗ - Stryker Instruments Div. of Stryker CorporationTerminatedSep 3, 2010
18G x 50mm/20 Tuohy Catheter Kit, REF 553-118-050, Rx, Sterile, Distributed by: Stryker Instruments, Kalamazoo, MI.
Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective, and catheter tips may break in patients.
Z-2366-2010 · View FDA record ↗ - Stryker Instruments Div. of Stryker CorporationTerminatedSep 3, 2010
18G x 90mm/20 Tuohy Catheter Kit, REF 553-118-090, Rx, Sterile, Distributed by: Stryker Instruments, Kalamazoo, MI.
Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective, and catheter tips may break in patients.
Z-2367-2010 · View FDA record ↗ - Stryker Instruments Div. of Stryker CorporationTerminatedSep 3, 2010
18G x 150m Tuohy Catheter Kit, REF 553-118-150, Rx, Sterile, Distributed by: Stryker Instruments, Kalamazoo, MI.
Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective, and catheter tips may break in patients.
Z-2368-2010 · View FDA record ↗ - Stryker Instruments Div. of Stryker CorporationTerminatedSep 3, 2010
17G x 50m Tuohy Catheter Kit, REF 553-218-50, Rx, Sterile, Distributed by: Stryker Instruments, Kalamazoo, MI.
Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective, and catheter tips may break in patients.
Z-2369-2010 · View FDA record ↗ - Stryker Instruments Div. of Stryker CorporationTerminatedSep 3, 2010
17G x 90m Tuohy Stimulation Catheter Kit, REF 553-218-90, Rx, Sterile, Distributed by: Stryker Instruments, Kalamazoo, MI.
Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective, and catheter tips may break in patients.
Z-2370-2010 · View FDA record ↗
Registered firms
130 firms currently registered for this product code
Rhythmlink International, Llc
Columbia, SC, US
Ives Eeg Solutions
Newburyport, MA, US
Titan Spine, A Division Of Medtronic
Milwaukee, WI, US
Covidien
- Santo Domingo, DO
Sterilization Services Of Georgia, Inc.
ATLANTA, GA, US
Sterigenics Us, Llc
Lewis Center, OH, US
Rhenus Se & Co. Kg
Holzwickede North Rhine-Westphalia, DE
Technomed Asia, Pt.
Bandung Jawa Barat, ID
Technomed Europe
Kerkrade Limburg, NL
Cbr Enterprise Limited
Hong Kong, HK
Veenak International Limited
BIRMINGHAM, GB
Alphatec Spine, Inc.
Carlsbad, CA, US
Sterigenics U.s., Llc
Atlanta, GA, US
Isomedix Operations Inc.
S Plainfield, NJ, US
Pine Moon Electronics Co., Ltd.
SHENZHEN CITY Guangdong, CN
Ad Supply Group Limited
London London, City of, GB
Teleflex Medical Llc
Morrisville, NC, US
Sterigenics Belgium Petit Rechain S.a.
Verviers Liege, BE
Sterigenics U.s. Llc
Hayward, CA, US
510(k) clearances
53 clearances for this product code
- Technomed EuropeDec 11, 2024
K241045 · Disposable Subdermal Needle Electrode, Corkscrew
- Suzhou Haishen Medical Device Associates Co., Ltd.Dec 4, 2023
K232581 · Medical Disposable Sterile Needle Electrode
- TeDan Surgical Innovations, Inc.Jun 29, 2023
K231691 · Phantom XL Insulated Dilators
- Rhythmlink International, LLCMay 27, 2020
K200984 · Guardian Needle Electrode
- Spes Medica SrlNov 22, 2019
K192603 · Spes Medica Subdermal Needle Electrodes
- Rhythmlink International, LLCJul 10, 2019
K190801 · PressOn Electrode Headset
- Daehan Medical Systems Co., Ltd.Dec 21, 2016
K161566 · DMS Disposable Subdermal Needle Electrodes
- Neuroinvent, Inc.Nov 5, 2014
K142470 · E-Shield Multi-paried Subdermal Needle Electrodes