Electrode, Needle
Regulation 882.1350
0510(k)s in 12 months (53 all time)
0recalls in 12 months (21 all time)
21recalls that name a 510(k)
Top companies in GXZ
| Company | 510(k)s | Recalls |
|---|---|---|
| Stryker Instruments Div. of Stryker Corporation | 0 | 19 |
| Rhythmlink International, LLC | 5 | 0 |
| Technomed Europe | 4 | 1 |
| Cadwell Laboratories, Inc. | 4 | 0 |
| Axon Systems, Inc. | 2 | 0 |
| Class A Ent. | 2 | 0 |
| The Electrode Store, Inc. | 2 | 0 |
| Ives Eeg Solutions, Inc. | 2 | 0 |
| Medicotest, Inc. | 2 | 0 |
| Neuroinvent, Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 11, 2024 | K241045 | Disposable Subdermal Needle Electrode, Corkscrew Technomed Europe, NL | GXZ |
| Dec 4, 2023 | K232581 | Medical Disposable Sterile Needle Electrode Suzhou Haishen Medical Device Associates Co., Ltd., CN | GXZ |
| Jun 29, 2023 | K231691 | Phantom XL Insulated Dilators TeDan Surgical Innovations, Inc. | GXZ |
| May 27, 2020 | K200984 | Guardian Needle Electrode Rhythmlink International, LLC | GXZ |
| Nov 22, 2019 | K192603 | Spes Medica Subdermal Needle Electrodes Spes Medica Srl, IT | GXZ |
| Jul 10, 2019 | K190801 | PressOn Electrode Headset Rhythmlink International, LLC | GXZ |
| Dec 21, 2016 | K161566 | DMS Disposable Subdermal Needle Electrodes Daehan Medical Systems Co., Ltd., KR | GXZ |
| Nov 5, 2014 | K142470 | E-Shield Multi-paried Subdermal Needle Electrodes Neuroinvent, Inc. | GXZ |
| Jul 18, 2014 | K140200 | E-SHIELD MULTI-PAIRED SUBDERMAL NEEDLE ELECTRODES Neuroinvent, Inc., TW | GXZ |
| Jul 22, 2013 | K130220 | MR CONDITIONAL PRESSON ELECTRODE Rhythmlink International, LLC | GXZ |
| Jul 19, 2013 | K130136 | DISPOSABLE AND REUSABLE CONCENTRIC NEEDLE ELECTRODES,DISPOSABLE AND REUSABLE SUBDERMAL NEEDLE ELECTRODES, Technomed Europe, NL | GXZ |
| Jul 12, 2012 | K121347 | PRESSON ELECTRODE Rhythmlink International, LLC | GXZ |
| Dec 8, 2011 | K103103 | PRESSON ELECTRODE Persyst Development Corp. | GXZ |
| Jul 28, 2011 | K110419 | AVS ARIA NEUROMONITORING PROBE AND AVS ARIA PROBE DILATORS Stryker Spine | GXZ |
| Aug 19, 2010 | K100912 | DISPOSABLE NERVE STIMULATING PROBE, BIPOLAR CONCENTRIC, DISPOSABLE NERVE STIMULATOR PROBE, BIPOLAR SIDE BY SIDE Kirwan Surgical Products, Inc. | GXZ |
| Jun 6, 2008 | K073229 | NERVE MONITORING CABLE Pioneer Surgical Technology | GXZ |
| May 16, 2008 | K072276 | SUBDERMAL NEEDLE ELECTRODES Xian Friendship Electronics Co., Ltd., CN | GXZ |
| Aug 21, 2007 | K063729 | DISPOSABLE PEDICLE SCREW PROBE, MODEL 3603-00 Technomed Europe, NL | GXZ |
| May 30, 2007 | K071185 | MODIFICATION TO: AMBU NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE Ambu A/S | GXZ |
| Jan 12, 2007 | K062996 | DISPOSABLE MONOPOLAR AND BIPOLAR STIMULATOR PROBES Axon Systems, Inc. | GXZ |
| Dec 22, 2006 | K062880 | SUBDERMAL WIRE ELECTRODE, MODEL SWE Ives Eeg Solutions, Inc., CA | GXZ |
| May 30, 2006 | K060189 | PEDIATRIC SUBDERMAL WIRE ELECTRODE (PSWE) Ives Eeg Solutions, Inc., CA | GXZ |
| Aug 17, 2005 | K052111 | XLTEK CLEAR SIGNAL SUB-DERMAL NEEDLE, MODELS 102889, 102798, 102799, 102382 Excel Tech. , Ltd., CA | GXZ |
| May 5, 2005 | K050325 | DISPOSABLE CONCENTRIC PROBE, DISPOSABLE BIPOLAR PROBE, DISPOSABLE MONOPOLAR PROBE Technomed Europe, NL | GXZ |
| Apr 26, 2005 | K050194 | AXON SYSTEMS SUBDERMAL NEEDLE ELECTRODES Axon Systems, Inc. | GXZ |
| May 21, 2004 | K040639 | ISURG DISPOSABLE SUBDERMAL NEEDLE ELECTRODE Isurgical | GXZ |
| Mar 18, 2003 | K023472 | LOW PROFILE EEG NEEDLE ELECTRODE, MODELS 112-812-18TP, 112-812-48TP, 112-812-60TP, 112-812-72TP, 112-812-96TP, 112-812 Class A Enterprises, Inc. | GXZ |
| Dec 20, 2002 | K022914 | RHYTHMLINK INTERNATIONAL SUBDERMAL NEEDLE ELECTRODES Rhythmlink International, LLC | GXZ |
| Jul 19, 2002 | K020910 | SUBDERMAL NEEDLE ELECTRODE FOR ELECTROENCEPHALOGRAPHY, MODELS PRO-E12SAF AND DEN-12SAF The Electrode Store, Inc. | GXZ |
| May 28, 2002 | K021118 | DETACHABLE MONOPOLAR EMG NEEDLE, MODELS 610-725, 610-737, 610-637, 610-744, 610-650, 610-570 Class A Ent. | GXZ |
| Mar 19, 2001 | K010019 | STERILE SUBDERMAL NEEDLE ELECTRODES Nicolet Biomedical, Inc. | GXZ |
| Aug 2, 2000 | K990100 | POLYMEDIC UPA NERVE STIMULATION NEEDLE; POLYMEDIC UPC NERVE STIMULATION NEEDLE Te ME NA S.A.R.L. | GXZ |
| Oct 22, 1999 | K990793 | ACCUGUIDE MUSCLE INJECTION MONITOR Medtronic Xomed | GXZ |
| Jan 11, 1999 | K983597 | NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODES Medicotest, Inc. | GXZ |
| Jan 28, 1998 | K974119 | DISPOSABLE NEEDLE ELECTRODE (ALM), DISPOSABLE NEEDLE ELECTRODE (DLM) Jack'S Electrodes | GXZ |
| Mar 25, 1996 | K950314 | DANTEC MONOPOLAR LUMEN ELECTRODE (13R18 AND 13R19) Dantec Medical, Inc. | GXZ |
| Dec 6, 1995 | K926094 | PROTECTRODE SYSTEM The Electrode Store, Inc. | GXZ |
| Mar 14, 1995 | K934779 | AGRAM SPYRAL ELECTRODE Agram Export-Import Co. | GXZ |
| Dec 29, 1994 | K933796 | EEG NEEDLE ELECTRODE Cadwell Laboratories, Inc. | GXZ |
| Apr 22, 1994 | K933806 | MONOPOLAR EMG NEEDLE ELECTRODE Cadwell Laboratories, Inc. | GXZ |
| Apr 22, 1994 | K933795 | CONCENTRIC EMG NEEDLE ELECTRODE Cadwell Laboratories, Inc. | GXZ |
| Apr 19, 1994 | K933793 | GROUND/REFERENCE NEEDLE ELECTRODE Cadwell Laboratories, Inc. | GXZ |
| Jul 29, 1993 | K926349 | PROBLOC INSULATED NEEDLES Life-Tech Intl., Inc. | GXZ |
| Aug 14, 1992 | K920352 | BIO-DETEK EEG ELECTRODE Bio-Detek, Inc. | GXZ |
| Feb 5, 1992 | K912783 | DISPOSABLE MONOPOLAR NEEDLE ELECTRODE Class A Ent. | GXZ |
| May 14, 1990 | K894911 | SENSORY NEEDLE ELECTRODE DNE 111-115,116-117,118 Dantec Electronics, Inc. | GXZ |
| May 11, 1990 | K901280 | DISPOSIBLE EEG NEEDLE ELECTRODES Medicotest, Inc. | GXZ |
| May 11, 1990 | K900740 | SPECIMEX DC Soredex Medical Systems | GXZ |
| Dec 22, 1989 | K896370 | DISP. CONCENTRIC NEEDLE ELECTRODE (DCP-30, DCP-45) Chalgren Enterprises, Inc. | GXZ |
| Sep 4, 1987 | K863136 | HIGH PROFILE NEEDLE ELECTRODE (N-SPYRAL HP) Neurotechnics, Inc. | GXZ |
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