Stimulator, Spinal-Cord, Implanted (Pain Relief)
Regulation 882.5880
0510(k)s in 12 months (139 all time)
1recalls in 12 months (6 all time)
5recalls that name a 510(k)
Top companies in GZB
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 23, 2024 | K233801 | Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation Boston Scientific Neuromodulation | GZB |
| Jun 10, 2022 | K221376 | Nalu Neurostimulation System Boston Scientific Neuromodulation | GZB |
| Mar 25, 2021 | K203547 | Nalu Neurostimulation System Boston Scientific Neuromodulation | GZB |
| Nov 9, 2020 | K202274 | Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 em: Single 8/Dual8), Boston Scientific Neuromodulation | GZB |
| Jul 15, 2020 | K201618 | Nalu Neurostimulation SCS system Boston Scientific Neuromodulation | GZB |
| Nov 7, 2019 | K191466 | SandShark Injectable Anchor (SIA) System Stimwave Technologies, Inc. | GZB |
| Jul 11, 2019 | K190960 | Nalu Lead Blank (50cm) Boston Scientific Neuromodulation | GZB |
| Mar 29, 2019 | K182720 | Freedom Spinal Cord Stimulator (SCS) System Stimwave Technologies Incorporated | GZB |
| Mar 22, 2019 | K183047 | Nalu Neurostimulation System Boston Scientific Neuromodulation | GZB |
| Sep 19, 2018 | K180981 | Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit Stimwave Technologies Incorporated | GZB |
| Nov 3, 2017 | K172644 | Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading Base Stimwave Technologies Incorporated | GZB |
| May 2, 2017 | K170141 | Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit Stimwave Technologies Incorporated | GZB |
| Dec 16, 2016 | K162161 | Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit Stimwave Technologies Incorporated | GZB |
| Aug 26, 2016 | K160600 | Freedom Spinal Cord Stimulator System Stimwave Technologies Incorporated | GZB |
| Jul 27, 2015 | K150924 | A.I.M. Lead Loop Suturing Device (1), A.I.M. Tension Assist/Suture Cutter Device, A.I.M. Lead Loop Suturing Device (1) p Anchor Innovation Medical (A.I.M.) | GZB |
| Jun 5, 2015 | K150517 | Freedom Spinal Cord Stimulator System Stimwave Technologies Incorporated | GZB |
| Oct 10, 2014 | K141399 | FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEM Stimwave Technologies Incorporated | GZB |
| May 2, 2014 | K140272 | SWIFT-LOCK ANCHOR St Jude Medical | GZB |
| Jun 18, 2013 | K130545 | MULTI LEAD TRIAL CABLE St Jude Medical | GZB |
| Jan 18, 2013 | K123299 | MTS SYSTEM, WIDE-SPACE QUATTRODE PERCUTANEOUS LEADS St. Jude Medical Neuromodulation | GZB |
| Apr 20, 2012 | K113611 | RAPID PROGRAMMER St Jude Medical | GZB |
| Feb 23, 2012 | K113805 | FIXATE TISSUE BAND Anulex Technologies, Inc. | GZB |
| Dec 16, 2011 | K113400 | FIXATE TISSUE BAND Anulex Technologies, Inc. | GZB |
| Nov 17, 2011 | K112214 | OCTRODEX(TM), QUATTRODEX(TM), INTRODEX(TM), EPIDURAL NEEDLE, STYLETS St. Jude Medical Neuromodulation | GZB |
| Oct 27, 2011 | K112849 | FIXATE TISSUE BAND Anulex Technologies, Inc. | GZB |
| Sep 8, 2011 | K111462 | FIXATE TISSUE BAND Anulex Technologies, Inc. | GZB |
| Oct 26, 2010 | K102523 | MULTI-LEAD TRIALING CABLE MODEL 355531 Medtronic, Inc. | GZB |
| Dec 23, 2009 | K092371 | SWIFT-LOCK ANCHOR, MODEL 1192 Advanced Neuromodulation Systems | GZB |
| Jul 31, 2009 | K091993 | RAPID PROGRAMMER, VERSION 3.3.0 Advanced Neuromodulation Systems, Inc. (Ans Inc.) | GZB |
| Jun 2, 2009 | K090907 | PENTA LEAD KITS, MODELS: 3227-3234 Advanced Neuromodulation Systems | GZB |
| Jul 18, 2008 | K081208 | CINCH ANCHOR, MODEL 1194 Advanced Neuromodulation Systems | GZB |
| Oct 11, 2007 | K072462 | WIDE SPACED QUATTRODE LEADS Advanced Neuromodulation Systems | GZB |
| Apr 11, 2007 | K070847 | TRIAL CABLE, 3009 Advanced Neuromodulation Systems | GZB |
| Dec 12, 2006 | K063080 | TRIPOLE 8C AND 16C AND EXCLAIM 8 LAMITRODE SERIES LEADS Advanced Neuromodulation Systems | GZB |
| Aug 16, 2006 | K062041 | MODEL 3875 1 X 8 SC TEST STIMULATION LEAD Medtronic, Inc. | GZB |
| Dec 15, 2005 | K053250 | ANS 90 CM AND 110 CM (3100 AND 3200 SERIES) LEAD KIT Advanced Neuromodulation Systems | GZB |
| Nov 22, 2005 | K052374 | RAPID PROGEAMMER 3.0 Advanced Neuromodulation Systems | GZB |
| Sep 26, 2005 | K052418 | AXXESS BUTTERFLY ANCHOR Advanced Neuromodulation Systems | GZB |
| Jul 28, 2005 | K051773 | MODEL 3873 1* 8 AND MODEL 3874 1* 8 COMPACT TEST STIMULATION LEADS Medtronic Inc.,Neurological Division. | GZB |
| May 18, 2005 | K050922 | ANS SCS ACCESSORY KIT Advanced Neuromodulation Systems | GZB |
| Apr 21, 2005 | K050633 | TRIAL CABLE RETENTION CLIP Advanced Neuromodulation Systems | GZB |
| Mar 25, 2004 | K040609 | RAPID PROGRAMMER Advanced Neuromodulation Systems | GZB |
| Mar 25, 2004 | K040568 | POLYETHER URETHANE MATERIAL CHANGE IN NEUROSTIMULATION LEADS Medtronic Vascular | GZB |
| Jan 30, 2004 | K033757 | MTS MULTIPROGRAM TRIAL STIMULATOR SYSTEM Advanced Neuromodulation Systems | GZB |
| Dec 4, 2003 | K033429 | LAMITRODE SPINAL CORD STIMULATION LEADS Advanced Neuromodulation Systems | GZB |
| Oct 30, 2003 | K033016 | PISCES Z QUAD LEAD MODEL, 3890, PISCES Z QUAD COMPACT LEAD MODEL, 3891, PISCES Z QUAD PLUS LEAD MODEL, 3892 Medtronic Neurological | GZB |
| Oct 6, 2003 | K032751 | MODIFICATION TO RENEW LEAD EXTENSION Advanced Neuromodulation Systems | GZB |
| Oct 3, 2003 | K032349 | PLACER Advanced Neuromodulation Systems | GZB |
| Oct 3, 2003 | K032034 | ANS AXXESS PERCUTANEOUS LEAD Advanced Neuromodulation Systems | GZB |
| Sep 11, 2003 | K032561 | RESUME II LEAD KIT FOR SPINAL CORD STIMULATION (SCS) AND PERIPHERAL NERVE STIMULATION (PNS), RESUME TL LEAD KIT FOR Medtronic Vascular | GZB |
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