510(k) clearances for Stimulator, Spinal-cord, Implanted (pain Relief)
139 on file
- Boston Scientific NeuromodulationAug 23, 2024
K233801 · Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation
- Boston Scientific NeuromodulationJun 10, 2022
K221376 · Nalu Neurostimulation System
- Boston Scientific NeuromodulationMar 25, 2021
K203547 · Nalu Neurostimulation System
- Boston Scientific NeuromodulationNov 9, 2020
K202274 · Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 em: Single 8/Dual8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 ern Kil, 40 cm/ 60 cm/60 em TrialJExtension Lead Kits, Patient Kits and miscellaneous replacement kits
- Boston Scientific NeuromodulationJul 15, 2020
K201618 · Nalu Neurostimulation SCS system
- Stimwave Technologies, Inc.Nov 7, 2019
K191466 · SandShark Injectable Anchor (SIA) System
- Boston Scientific NeuromodulationJul 11, 2019
K190960 · Nalu Lead Blank (50cm)
- Stimwave Technologies IncorporatedMar 29, 2019
K182720 · Freedom Spinal Cord Stimulator (SCS) System
- Boston Scientific NeuromodulationMar 22, 2019
K183047 · Nalu Neurostimulation System
- Stimwave Technologies IncorporatedSep 19, 2018
K180981 · Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit
- Stimwave Technologies IncorporatedNov 3, 2017
K172644 · Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading Base
- Stimwave Technologies IncorporatedMay 2, 2017
K170141 · Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit
- Stimwave Technologies IncorporatedDec 16, 2016
K162161 · Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit
- Stimwave Technologies IncorporatedAug 26, 2016
K160600 · Freedom Spinal Cord Stimulator System
- Anchor Innovation Medical (A.I.M.)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) plus Tension Assist/Suture Cutter Device, A.I.M. Lead Loop Suturing Device (2), A.I.M. Lead Loop Suturing Device plus Tension Assist/Suture Cutter Device
- Stimwave Technologies IncorporatedJun 5, 2015
K150517 · Freedom Spinal Cord Stimulator System
- Stimwave Technologies IncorporatedOct 10, 2014
K141399 · FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEM
- St Jude MedicalMay 2, 2014
K140272 · SWIFT-LOCK ANCHOR
- St Jude MedicalJun 18, 2013
K130545 · MULTI LEAD TRIAL CABLE
- St. Jude Medical NeuromodulationJan 18, 2013
K123299 · MTS SYSTEM, WIDE-SPACE QUATTRODE PERCUTANEOUS LEADS
- St Jude MedicalApr 20, 2012
K113611 · RAPID PROGRAMMER
- Anulex Technologies, Inc.Feb 23, 2012
K113805 · FIXATE TISSUE BAND
- Anulex Technologies, Inc.Dec 16, 2011
K113400 · FIXATE TISSUE BAND
- St. Jude Medical NeuromodulationNov 17, 2011
K112214 · OCTRODEX(TM), QUATTRODEX(TM), INTRODEX(TM), EPIDURAL NEEDLE, STYLETS
- Anulex Technologies, Inc.Oct 27, 2011
K112849 · FIXATE TISSUE BAND
- Anulex Technologies, Inc.Sep 8, 2011
K111462 · FIXATE TISSUE BAND
- Medtronic, Inc.Oct 26, 2010
K102523 · MULTI-LEAD TRIALING CABLE MODEL 355531
- Advanced Neuromodulation SystemsDec 23, 2009
K092371 · SWIFT-LOCK ANCHOR, MODEL 1192
- Advanced Neuromodulation Systems, Inc. (Ans Inc.)Jul 31, 2009
K091993 · RAPID PROGRAMMER, VERSION 3.3.0
- Advanced Neuromodulation SystemsJun 2, 2009
K090907 · PENTA LEAD KITS, MODELS: 3227-3234
- Advanced Neuromodulation SystemsJul 18, 2008
K081208 · CINCH ANCHOR, MODEL 1194
- Advanced Neuromodulation SystemsOct 11, 2007
K072462 · WIDE SPACED QUATTRODE LEADS
- Advanced Neuromodulation SystemsApr 11, 2007
K070847 · TRIAL CABLE, 3009
- Advanced Neuromodulation SystemsDec 12, 2006
K063080 · TRIPOLE 8C AND 16C AND EXCLAIM 8 LAMITRODE SERIES LEADS
- Medtronic, Inc.Aug 16, 2006
K062041 · MODEL 3875 1 X 8 SC TEST STIMULATION LEAD
- Advanced Neuromodulation SystemsDec 15, 2005
K053250 · ANS 90 CM AND 110 CM (3100 AND 3200 SERIES) LEAD KIT
- Advanced Neuromodulation SystemsNov 22, 2005
K052374 · RAPID PROGEAMMER 3.0
- Advanced Neuromodulation SystemsSep 26, 2005
K052418 · AXXESS BUTTERFLY ANCHOR
- Medtronic Inc.,Neurological Division.Jul 28, 2005
K051773 · MODEL 3873 1* 8 AND MODEL 3874 1* 8 COMPACT TEST STIMULATION LEADS
- Advanced Neuromodulation SystemsMay 18, 2005
K050922 · ANS SCS ACCESSORY KIT
- Advanced Neuromodulation SystemsApr 21, 2005
K050633 · TRIAL CABLE RETENTION CLIP
- Medtronic VascularMar 25, 2004
K040568 · POLYETHER URETHANE MATERIAL CHANGE IN NEUROSTIMULATION LEADS
- Advanced Neuromodulation SystemsMar 25, 2004
K040609 · RAPID PROGRAMMER
- Advanced Neuromodulation SystemsJan 30, 2004
K033757 · MTS MULTIPROGRAM TRIAL STIMULATOR SYSTEM
- Advanced Neuromodulation SystemsDec 4, 2003
K033429 · LAMITRODE SPINAL CORD STIMULATION LEADS
- Medtronic NeurologicalOct 30, 2003
K033016 · PISCES Z QUAD LEAD MODEL, 3890, PISCES Z QUAD COMPACT LEAD MODEL, 3891, PISCES Z QUAD PLUS LEAD MODEL, 3892
- Advanced Neuromodulation SystemsOct 6, 2003
K032751 · MODIFICATION TO RENEW LEAD EXTENSION
- Advanced Neuromodulation SystemsOct 3, 2003
K032349 · PLACER
- Advanced Neuromodulation SystemsOct 3, 2003
K032034 · ANS AXXESS PERCUTANEOUS LEAD
- Medtronic VascularSep 11, 2003
K032561 · RESUME II LEAD KIT FOR SPINAL CORD STIMULATION (SCS) AND PERIPHERAL NERVE STIMULATION (PNS), RESUME TL LEAD KIT FOR
- Advanced Neuromodulation SystemsApr 24, 2003
K030461 · A127 LEAD EXTENSION
- Advanced Neuromodulation SystemsMar 28, 2003
K030674 · MODIFICATION TO AXXESS SPINAL CORD STIMULATION LEAD
- Advanced Neuromodulation SystemsMar 11, 2003
K030118 · RAPID PROGRAMMAR
- Advanced Neuromodulation System,IncAug 8, 2002
K022222 · LAMITRODE S-SERIES (S4 AND S8) LEADS
- Advanced Neuromodulation SystemsJun 6, 2002
K021518 · PAINDOC
- Medamicus, Inc.Jan 24, 2002
K013120 · PERCUTANEOUS INTRODUCER SET, MODEL 042294 AND KIT MODEL 3550-18
- Medtronic NeurologicalDec 11, 2001
K013063 · GRIP LOCK ANCHOR, MODEL 411374
- Medtronic VascularAug 1, 2001
K010300 · MEDTRONIC MODEL 7495LZ LOW IMPEDANCE EXTENSION
- Micronet Medical, Inc.Jul 16, 2001
K010008 · AXXESS SPINAL CORD STIMULATION LEAD, MODEL 8000 SERIES, INCLUDING 80XX, 81XX, AND 82XX
- Medtronic VascularJun 22, 2001
K011584 · MEDTRONIC SPINAL CORD STIMULATION AND PERIPHERAL NERVE STIMULATION SYSTEMS FOR PAIN RELIEF
- Medtronic VascularApr 28, 2000
K000445 · MEDTRONIC MODEL 7499 EXTENSION
- Medamicus, Inc.Mar 1, 2000
K994097 · MEDAMICUS EPIDURAL INTRODUCER
- Advanced Neuromodulation SystemsSep 24, 1999
K992946 · RENEW RECEIVER
- Advanced Neuromodulation SystemsJun 24, 1999
K991784 · RENEW LEAD EXTENSION
- Advanced Neuromodulation SystemsJun 3, 1999
K990469 · LAMITRODE LEADS
- Medtronic VascularFeb 9, 1999
K990104 · MEDTRONIC MODEL 7495 EXTENSION KIT
- Medtronic VascularFeb 6, 1998
K972906 · MEDTRONIC TWIST LOCK ANCHOR (PARTNUMBER 103953/3550TLA)
- Medtronic VascularFeb 3, 1998
K971756 · MEDTRONIC MODEL 3998 LEAD
- Medtronic VascularAug 22, 1997
K972043 · MEDTRONIC MODEL 3273/3274 RF RECEIVER AND MODEL 3629/3630 SCREENER
- Medtronic VascularJul 3, 1997
K964172 · MEDTRONIC MODEL 3991A, 3992A, 3993A, 3994A LEADS OR TRANSVERSE TRIPOLAR LEADS OR TTL
- Medtronic VascularNov 19, 1996
K953742 · BIFURCATED Y-EXTENSION
- Neuromed, Inc.May 22, 1996
K960728 · ONE STEP CONNECT LEADS (QUATTRODE, OCTRODE, CERVITRODE)
- Medtronic VascularMay 17, 1996
K955291 · DUALSCREEN
- Medtronic VascularNov 27, 1995
K954886 · MODEL NOS. 7495 AND 501826 EXTENSIONS
- Regulatory & Marketing Services, Inc.Oct 13, 1995
K941342 · PAIN DOC
- Medtronic VascularAug 30, 1995
K952459 · MEDTRONIC MODEL 3991, 3991C, 3992, 3992C, 3993, 3993C, 3994, 3994C LEADS OR, TRANSVERSE TRIPOLAR LEADS OR, TTL
- Medtronic VascularApr 12, 1995
K943537 · MODEL 3470 X-TREL RF RECEIVER
- Medtronic VascularFeb 14, 1995
K934065 · MEDTRONIC MATTRIX 3271/3272 NEUROSTIMULATION SYSTEM
- Medtronic VascularJan 30, 1995
K950127 · ALTERNATE 100% ETO STERILIZATION PROCESS AND ALTERNATE STERILIZATION FACCILITY
- Medtronic VascularJan 11, 1995
K945103 · TEMP AND PERMANENT NEURO LEADS (VARIOUS MODELS)
- Neuromed, Inc.Dec 15, 1994
K930536 · NEUROMED OCTRODE MODEL MNR-88A-B-C NEUROSTIM REC
- Neuromed, Inc.Dec 12, 1994
K930498 · NEUROMED OCTRODE MODEL MNT-98 NEUROSTIMULATOR TRAN
- Medtronic VascularJul 18, 1994
K940416 · NEUROLOGICAL LEADS (PACKAGING MODIFICATION)
- Medtronic VascularJul 11, 1994
K936099 · NEUROLOGICAL LEAD ACCESSORIES
- Medtronic VascularJun 14, 1994
K934938 · TEMPORARY SCREENING LEAD/CATHETER KIT
- Medtronic VascularMay 4, 1994
K932202 · MODEL 3862A & B 3863A & B TEMP. LEAD SCREENING KIT
- Medtronic VascularFeb 3, 1994
K932948 · MEDTRONIC MODEL 3625 SCREENER SYSTEM
- Neuromed, Inc.Feb 2, 1994
K930242 · INTRODE INT-8
- Neuromed, Inc.May 5, 1993
K921319 · NEUROMED MODEL OCA-30 OCTODE AND MODEL SCA-30
- Medtronic VascularMar 18, 1993
K923931 · MEDTRONIC MODEL 3487A PISCES-QUAD LEAD
- Medtronic VascularMar 18, 1993
K924522 · MEDTRONIC MODEL 3080 PISCES-QUAD LEAD
- Medtronic VascularNov 5, 1992
K923567 · MEDTRONIC MODEL 3888 PISCES-QUAD PLUS LEAD
- Medtronic VascularJul 7, 1992
K921558 · MEDTRONIC MODELS 3983A AND 3983B RESUME LEADS
- Medtronic VascularFeb 7, 1992
K913993 · MEDTRONIC MODELS 3982 A,B,C&D STAG ARRAY RES LEADS
- Medtronic VascularJan 22, 1992
K913934 · MEDTRONIC MODEL 3586 RESUME LEAD
- Medtronic VascularDec 23, 1991
K914433 · MEDTRONIC MDLS 3487/3487A/3587/3587A SCS LEADS
- Medtronic VascularNov 22, 1991
K912764 · MEDTRONIC MODEL 3861 TEMPORARY SCREENING LEAD KIT
- Medtronic VascularNov 22, 1991
K913442 · MEDTRONIC 3625 SCREENER SYSTEM
- Biomedical Life Systems, Inc.Jun 27, 1991
K905569 · ELECTRO-NERVE STIMULATOR TENS,MODEL SYSTEMS PLUS/A
- Northumbria Biologicals , Ltd.Mar 11, 1991
K905402 · ANTIGENZ CHLAMYDIA
- Neuromed, Inc.Mar 11, 1991
K905596 · NEUROMED OCTRODE MODEL MNR-88B/88C NEUROSTIM SYST
- Medtronic VascularFeb 14, 1991
K903690 · MEDTRONIC (R) MODEL 3625 SCREENER
- Medtronic VascularFeb 11, 1991
K910199 · MEDTRONIC MODEL 3487A PISCES-QUAD LEAD
- Medtronic VascularFeb 1, 1991
K905407 · MODEL 3487A PISCES-QUAD,3587A RESUME,3586 RESUME
- Neuromed, Inc.Jan 25, 1991
K905255 · NEUROMED MODEL 1992 LS LAMITRODE LEAD
- Neuromed, Inc.Jan 16, 1991
K903814 · NEUROMED TS8 TEST STIMULATOR
- Neuromed, Inc.Jun 29, 1990
K901499 · NEUROMED OCTRODE MODEL MNR-88 W/98 ADAPTER NEURO.
- Medtronic VascularApr 30, 1990
K890061 · MODEL 3586 RESUME LEAD
- Medtronic VascularAug 7, 1989
K892884 · MEDTRONIC MODEL 3530 PERCUTANEOUS EXTENSION
- Medtronic VascularJan 17, 1989
K884948 · MODEL 3587A RESUME EPIDURAL LEAD
- Medtronic VascularJan 17, 1989
K885033 · MODEL 3487A PISCES EPIDURAL LEAD
- Medtronic VascularNov 30, 1988
K883780 · XTREL, MODEL NUMBER 3425
- Medtronic VascularMay 25, 1988
K881491 · MODEL 3487A PISCES EPIDURAL LEAD
- Medtronic VascularOct 6, 1987
K873675 · MODIFIED #3587 RESUME SE-4/#3487 PISCES-QUAD
- Neuromed, Inc.Oct 6, 1986
K862915 · MULTISTIM(4-CHANNEL), MULTISTIM-OCTRODE(8 CHANNEL)
- Medtronic VascularMay 9, 1986
K855107 · MEDTRONIC MODEL 3422A TRANSMITTER ANTENNA KIT
- Neuromed, Inc.Apr 4, 1986
K860185 · UNISTIM UNT-1M NEUROSTIMULATOR TRANSMITTER
- Neuromed, Inc.Mar 7, 1986
K860158 · 8-CHANNEL MULTIPROG IMPLANT SPINAL CORD STIMULATOR
- Neuromed, Inc.Nov 14, 1985
K853643 · MULTISTIM LAMINECTOMY ELECTRODE
- Neuromed, Inc.Nov 14, 1985
K852326 · UNISTIM UNT-1
- Neuromed, Inc.Oct 10, 1985
K852920 · QUADRA CATH ELECT(3MM SIZES) 1990J, JF, JP + JPF
- Cordis Corp.Aug 14, 1985
K852827 · CORDIS EXTERNAL NEURAL STIMULATOR MODEL 911A
- Medtronic VascularFeb 6, 1985
K844115 · MEDTRONIC 3465 SE-4F RECEIVER/EXTENSION FOR SPINAL
- Medtronic VascularMay 14, 1984
K841584 · MEDTRONIC RESUME SE-4 3587-LEAD-SPINAL
- Medtronic VascularMar 19, 1984
K833990 · SPINAL CORD STIMULATION SYS SE-4
- Instromedix, Inc.Dec 1, 1983
K833809 · NEURAL STIMULATOR MONITOR
- Medtronic VascularAug 11, 1983
K831746 · PISCES #3487 EPIDURAL LEAD FOR SPINAL
- Cordis Corp.Dec 15, 1982
K823530 · STIMUCORD EXTERNAL NEURAL STIM. 911A
- Medtronic VascularJun 23, 1982
K820988 · MEDTRONIC #1992-2 DUAL RATE TRANSMITTER
- Medtronic VascularOct 8, 1981
K812155 · MEDTRONIC DUAL CHANNEL SPINAL CORD STIM
- Medtronic VascularAug 20, 1981
K812154 · MEDTRONIC #3484 PISCES EPIDURAL LEAD
- Medtronic VascularJul 1, 1981
K811655 · MYELOSTAT DORSAL CORD STIMULATOR
- Electronic Diagnostics, Inc.Apr 3, 1981
K810182 · PROGRAMMABLE SPINAL CORAL STIM. SYSTEM
- Cordis Corp.Feb 19, 1981
K810319 · CORDIS STIMUCORD EXTERNAL NEUTRAL STIM
- Medtronic VascularJul 8, 1980
K801384 · MYELOSTAT DORSAL CORD STIMULATOR, ETC.
- Medtronic VascularFeb 5, 1980
K800193 · MEDTRONIC PISCES GENERATION II LEAD KIT
- Medtronic VascularMay 25, 1979
K790790 · PISCES-SELECTOR X
- Medtronic VascularMay 19, 1978
K780758 · NEUROLOGICAL SCREENING STIMULATOR M 3623
- Medtronic VascularJan 17, 1978
K780001 · EPIDURAL LEAD - MODEL 3481