GXZ · Class II · 21 CFR 882.1350

FDA Product Code GXZ: Electrode, Needle

Leading manufacturers include Rhythmlink International, LLC, Cadwell Laboratories, Inc. and Technomed Europe.

53
Total
53
Cleared
194d
Avg days
1978
Since
53 devices
25–48 of 53
Cleared Apr 26, 2005
AXON SYSTEMS SUBDERMAL NEEDLE ELECTRODES
K050194
Axon Systems, Inc.
Neurology · 89d
Cleared May 21, 2004
ISURG DISPOSABLE SUBDERMAL NEEDLE ELECTRODE
K040639
Isurgical
Neurology · 72d
Cleared Mar 18, 2003
LOW PROFILE EEG NEEDLE ELECTRODE, MODELS 112-812-18TP, 112-812-48TP, 112-812-60TP, 112-812-72TP, 112-812-96TP, 112-812
K023472
Class A Enterprises, Inc.
Neurology · 153d
Cleared Dec 20, 2002
RHYTHMLINK INTERNATIONAL SUBDERMAL NEEDLE ELECTRODES
K022914
Rhythmlink International, LLC
Neurology · 108d
Cleared Jul 19, 2002
SUBDERMAL NEEDLE ELECTRODE FOR ELECTROENCEPHALOGRAPHY, MODELS PRO-E12SAF AND DEN-12SAF
K020910
The Electrode Store, Inc.
Neurology · 121d
Cleared May 28, 2002
DETACHABLE MONOPOLAR EMG NEEDLE, MODELS 610-725, 610-737, 610-637, 610-744, 610-650, 610-570
K021118
Class A Ent.
Neurology · 50d
Cleared Mar 19, 2001
STERILE SUBDERMAL NEEDLE ELECTRODES
K010019
Nicolet Biomedical, Inc.
Neurology · 76d
Cleared Aug 02, 2000
POLYMEDIC UPA NERVE STIMULATION NEEDLE
K990100
Te ME NA S.A.R.L.
Neurology · 576d
Cleared Oct 22, 1999
ACCUGUIDE MUSCLE INJECTION MONITOR
K990793
Medtronic Xomed
Neurology · 226d
Cleared Jan 11, 1999
NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODES
K983597
Medicotest, Inc.
Neurology · 90d
Cleared Jan 28, 1998
DISPOSABLE NEEDLE ELECTRODE (ALM), DISPOSABLE NEEDLE ELECTRODE (DLM)
K974119
Jack'S Electrodes
Neurology · 89d
Cleared Mar 25, 1996
DANTEC MONOPOLAR LUMEN ELECTRODE (13R18 AND 13R19)
K950314
Dantec Medical, Inc.
Neurology · 424d
Cleared Dec 06, 1995
PROTECTRODE SYSTEM
K926094
The Electrode Store, Inc.
Neurology · 1099d
Cleared Mar 14, 1995
AGRAM SPYRAL ELECTRODE
K934779
Agram Export-Import Co.
Neurology · 524d
Cleared Dec 29, 1994
EEG NEEDLE ELECTRODE
K933796
Cadwell Laboratories, Inc.
Neurology · 512d
Cleared Apr 22, 1994
CONCENTRIC EMG NEEDLE ELECTRODE
K933795
Cadwell Laboratories, Inc.
Neurology · 261d
Cleared Apr 22, 1994
MONOPOLAR EMG NEEDLE ELECTRODE
K933806
Cadwell Laboratories, Inc.
Neurology · 261d
Cleared Apr 19, 1994
GROUND/REFERENCE NEEDLE ELECTRODE
K933793
Cadwell Laboratories, Inc.
Neurology · 258d
Cleared Jul 29, 1993
PROBLOC INSULATED NEEDLES
K926349
Life-Tech Intl., Inc.
Neurology · 224d
Cleared Aug 14, 1992
BIO-DETEK EEG ELECTRODE
K920352
Bio-Detek, Inc.
Neurology · 200d
Cleared Feb 05, 1992
DISPOSABLE MONOPOLAR NEEDLE ELECTRODE
K912783
Class A Ent.
Neurology · 226d
Cleared May 14, 1990
SENSORY NEEDLE ELECTRODE DNE 111-115,116-117,118
K894911
Dantec Electronics, Inc.
Neurology · 286d
Cleared May 11, 1990
SPECIMEX DC
K900740
Soredex Medical Systems
Radiology · 84d
Cleared May 11, 1990
DISPOSIBLE EEG NEEDLE ELECTRODES
K901280
Medicotest, Inc.
Neurology · 53d