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Electrode, Needle

FDA product code GXZ · 51 cleared devices

Class 2 Neurology

Regulation: 21 CFR 882.1350
Review panel: NE
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1978-08-21 – 2024-12-11

GXZ 2024-12-11

Disposable Subdermal Needle Electrode, Corkscrew

Applicant Technomed Europe

K number K241045

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GXZ 2023-12-04

Medical Disposable Sterile Needle Electrode

Applicant Suzhou Haishen Medical Device Associates Co., Ltd.

K number K232581

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GXZ 2023-06-29

Phantom XL Insulated Dilators

Applicant TeDan Surgical Innovations, Inc.

K number K231691

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GXZ 2020-05-27

Guardian Needle Electrode

Applicant Rhythmlink International, LLC

K number K200984

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GXZ 2019-11-22

Spes Medica Subdermal Needle Electrodes

Applicant Spes Medica Srl

K number K192603

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GXZ 2019-07-10

PressOn Electrode Headset

Applicant Rhythmlink International, LLC

K number K190801

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GXZ 2016-12-21

DMS Disposable Subdermal Needle Electrodes

Applicant Daehan Medical Systems Co., Ltd.

K number K161566

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GXZ 2013-07-22

MR CONDITIONAL PRESSON ELECTRODE

Applicant Rhythmlink International, LLC

K number K130220

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GXZ 2013-07-19

DISPOSABLE AND REUSABLE CONCENTRIC NEEDLE ELECTRODES,DISPOSABLE AND REUSABLE SUBDERMAL NEEDLE ELECTRODES,

Applicant Technomed Europe

K number K130136

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GXZ 2012-07-12

PRESSON ELECTRODE

Applicant Rhythmlink International, LLC

K number K121347

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GXZ 2011-12-08

PRESSON ELECTRODE

Applicant Persyst Development Corp.

K number K103103

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GXZ 2011-07-28

AVS ARIA NEUROMONITORING PROBE AND AVS ARIA PROBE DILATORS

Applicant Stryker Spine

K number K110419

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GXZ 2010-08-19

DISPOSABLE NERVE STIMULATING PROBE, BIPOLAR CONCENTRIC, DISPOSABLE NERVE STIMULATOR PROBE, BIPOLAR SIDE BY SIDE

Applicant Kirwan Surgical Products, Inc.

K number K100912

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GXZ 2008-06-06

NERVE MONITORING CABLE

Applicant Pioneer Surgical Technology

K number K073229

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GXZ 2008-05-16

SUBDERMAL NEEDLE ELECTRODES

Applicant Xian Friendship Electronics Co., Ltd.

K number K072276

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GXZ 2007-08-21

DISPOSABLE PEDICLE SCREW PROBE, MODEL 3603-00

Applicant Technomed Europe

K number K063729

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GXZ 2007-05-30

MODIFICATION TO: AMBU NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE

Applicant Ambu A/S

K number K071185

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GXZ 2007-01-12

DISPOSABLE MONOPOLAR AND BIPOLAR STIMULATOR PROBES

Applicant Axon Systems, Inc.

K number K062996

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GXZ 2006-12-22

SUBDERMAL WIRE ELECTRODE, MODEL SWE

Applicant Ives Eeg Solutions, Inc.

K number K062880

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GXZ 2006-05-30

PEDIATRIC SUBDERMAL WIRE ELECTRODE (PSWE)

Applicant Ives Eeg Solutions, Inc.

K number K060189

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GXZ 2005-08-17

XLTEK CLEAR SIGNAL SUB-DERMAL NEEDLE, MODELS 102889, 102798, 102799, 102382

Applicant Excel Tech. , Ltd.

K number K052111

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GXZ 2005-05-05

DISPOSABLE CONCENTRIC PROBE, DISPOSABLE BIPOLAR PROBE, DISPOSABLE MONOPOLAR PROBE

Applicant Technomed Europe

K number K050325

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GXZ 2005-04-26

AXON SYSTEMS SUBDERMAL NEEDLE ELECTRODES

Applicant Axon Systems, Inc.

K number K050194

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GXZ 2004-05-21

ISURG DISPOSABLE SUBDERMAL NEEDLE ELECTRODE

Applicant Isurgical

K number K040639

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GXZ 2003-03-18

LOW PROFILE EEG NEEDLE ELECTRODE, MODELS 112-812-18TP, 112-812-48TP, 112-812-60TP, 112-812-72TP, 112-812-96TP, 112-812

Applicant Class A Enterprises, Inc.

K number K023472

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GXZ 2002-12-20

RHYTHMLINK INTERNATIONAL SUBDERMAL NEEDLE ELECTRODES

Applicant Rhythmlink International, LLC

K number K022914

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GXZ 2002-07-19

SUBDERMAL NEEDLE ELECTRODE FOR ELECTROENCEPHALOGRAPHY, MODELS PRO-E12SAF AND DEN-12SAF

Applicant The Electrode Store, Inc.

K number K020910

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GXZ 2002-05-28

DETACHABLE MONOPOLAR EMG NEEDLE, MODELS 610-725, 610-737, 610-637, 610-744, 610-650, 610-570

Applicant Class A Ent.

K number K021118

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GXZ 2001-03-19

STERILE SUBDERMAL NEEDLE ELECTRODES

Applicant Nicolet Biomedical, Inc.

K number K010019

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GXZ 2000-08-02

POLYMEDIC UPA NERVE STIMULATION NEEDLE; POLYMEDIC UPC NERVE STIMULATION NEEDLE

Applicant Te ME NA S.A.R.L.

K number K990100

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GXZ 1999-10-22

ACCUGUIDE MUSCLE INJECTION MONITOR

Applicant Medtronic Xomed

K number K990793

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GXZ 1999-01-11

NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODES

Applicant Medicotest, Inc.

K number K983597

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GXZ 1998-01-28

DISPOSABLE NEEDLE ELECTRODE (ALM), DISPOSABLE NEEDLE ELECTRODE (DLM)

Applicant Jack'S Electrodes

K number K974119

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GXZ 1996-03-25

DANTEC MONOPOLAR LUMEN ELECTRODE (13R18 AND 13R19)

Applicant Dantec Medical, Inc.

K number K950314

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GXZ 1995-12-06

PROTECTRODE SYSTEM

Applicant The Electrode Store, Inc.

K number K926094

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GXZ 1995-03-14

AGRAM SPYRAL ELECTRODE

Applicant Agram Export-Import Co.

K number K934779

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GXZ 1994-12-29

EEG NEEDLE ELECTRODE

Applicant Cadwell Laboratories, Inc.

K number K933796

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GXZ 1994-04-22

MONOPOLAR EMG NEEDLE ELECTRODE

Applicant Cadwell Laboratories, Inc.

K number K933806

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GXZ 1994-04-22

CONCENTRIC EMG NEEDLE ELECTRODE

Applicant Cadwell Laboratories, Inc.

K number K933795

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GXZ 1994-04-19

GROUND/REFERENCE NEEDLE ELECTRODE

Applicant Cadwell Laboratories, Inc.

K number K933793

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GXZ 1993-07-29

PROBLOC INSULATED NEEDLES

Applicant Life-Tech Intl., Inc.

K number K926349

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GXZ 1992-08-14

BIO-DETEK EEG ELECTRODE

Applicant Bio-Detek, Inc.

K number K920352

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GXZ 1992-02-05

DISPOSABLE MONOPOLAR NEEDLE ELECTRODE

Applicant Class A Ent.

K number K912783

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GXZ 1990-05-14

SENSORY NEEDLE ELECTRODE DNE 111-115,116-117,118

Applicant Dantec Electronics, Inc.

K number K894911

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GXZ 1990-05-11

DISPOSIBLE EEG NEEDLE ELECTRODES

Applicant Medicotest, Inc.

K number K901280

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GXZ 1990-05-11

SPECIMEX DC

Applicant Soredex Medical Systems

K number K900740

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GXZ 1989-12-22

DISP. CONCENTRIC NEEDLE ELECTRODE (DCP-30, DCP-45)

Applicant Chalgren Enterprises, Inc.

K number K896370

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GXZ 1987-09-04

HIGH PROFILE NEEDLE ELECTRODE (N-SPYRAL HP)

Applicant Neurotechnics, Inc.

K number K863136

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GXZ 1987-09-04

LOW PROFILE NEEDLE ELECTRODE (N-SPYRAL LP)

Applicant Neurotechnics, Inc.

K number K863135

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GXZ 1985-04-11

CONCENTRIC NEEDLE ELECTRODES-VARIOUS SIZES W/CONNE

Applicant Nicolet Biomedical Instruments

K number K850107

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GXZ 1978-08-21

ELECTRODE, NEEDLE, CFM

Applicant Applied Medical Research

K number K781311

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