meddevicedb.com FDA Device Reference

Review Panel

Neurology FDA 510(k) Clearances & Devices

Cleared Devices
6,130
Product Codes (page)
37
Latest Decision
2004-01-30

Clearances · page 34 of 62

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K033757 MTS MULTIPROGRAM TRIAL STIMULATOR SYSTEM Advanced Neuromodulation Systems GZB Class II 2004-01-30
K033621 NDI PASSIVE SPHERES Northern Digital, Inc. HAW Class II 2004-01-27
K032303 STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM Stryker Instruments HBE Class II 2004-01-16
K030267 EEG MONITOR WITH BIS, MODEL A-2000 Aspect Medical Systems, Inc. OLW Class II 2004-01-15
K033455 ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS03-5 Biomedical Life Systems, Inc. GZJ Class II 2004-01-15
K033850 MEDTRONIC PS MEDICAL STRATA NSC VALVE AND SHUNT ASSEMBLIES WITH AND WITHOUT BIOGLIDE Medtronic Neurosurgery JXG Class II 2004-01-13
K033372 SAPPHIRE DETACHABLE FIBERED COIL SYSTEM, HELIX FIBERED, CYCLONE, MULTIPLE MODELS Micro Therapeutics, Inc. HCG Class II 2004-01-09
K033475 WIRELESS INPUT UNIT, MODEL WEE-1000A SERIES Nihon Kohden America, Inc. OLV Class II 2004-01-07
K033413 SPINEASSIST DEVICE Mazor Surgical Technologies , Ltd. HAW Class II 2004-01-07
K032003 PREMIER PLUS American Imex GZJ Class II 2004-01-07
K033660 STORZ RANEY SCALP CLIP, MODEL 1-20-004-05 Rudolf Storz GmbH HBO Class II 2004-01-07
K033836 HYDROCOIL EMBOLIC SYSTEM (HES) MicroVention, Inc. HCG Class II 2003-12-30
K032928 MEDIPHYSICS PAIN TREATMENT SYSTEM, MODEL 1 Mediphysics Pain Centers of America GZJ Class II 2003-12-19
K033857 T-TECH DIGITAL, MODEL WL-22XXA SERIES Well-Life Healthcare, Inc. GZJ Class II 2003-12-19
K033698 CONTOUR-FLEX VALVE AND SHUNT SYSTEM Integra Neurosciences Implants S.A. JXG Class II 2003-12-17
K033052 CONDUCTIVE EEG ELECTROLYTE Compumedics USA, Ltd. GYB Class II 2003-12-17
K032741 EPOCHXP NEUROLOGICAL WORKSTATION,EPOCHXP LITE NEUROLOGICAL WORKSTATION Axon Systems, Inc. GWF Class II 2003-12-16
K032994 GM3 SERIES HV TENS, MODEL GM3X3HV (WHERE X IS PARAMETER OF DIFFERENT HOUSING) Gemore Technology Co, Ltd. GZJ Class II 2003-12-16
K033230 TRACERS TA BONE CEMENT OPACIFIER, MODEL TCR-TA Parallax Medical, Inc. MYU Class II 2003-12-12
K032719 GM3 SERIES IF TENS, MODEL GM3X2IF (WHERE X IS A PARAMETER OF DIFFERENT HOUSING) Gemore Technology Co, Ltd. LIH Class II 2003-12-10
K032720 GEM-STIM TENS, MODELS GM3XY AND GM3AXY Gemore Technology Co, Ltd. GZJ Class II 2003-12-10
K032970 ACRA-CUT XPRESS 120 Acra Cut, Inc. HBF Class II 2003-12-08
K030829 VPT METER Xilas Medical, Inc. LLN Class I 2003-12-05
K033429 LAMITRODE SPINAL CORD STIMULATION LEADS Advanced Neuromodulation Systems GZB Class II 2003-12-04
K032872 MICRUS MICROCOIL SYSTEM Micrus Corp. HCG Class II 2003-11-28
K031374 BESMED VARIOUS MODELS OF TENS, BE-550/BE-660 Besmed Health Business Corp GZJ Class II 2003-11-28
K032331 DORO RADIOLUCENT HEADREST SYSTEM AND HORSESHOE HEADRESTS,AND NON-RADIOLUCENT J-ARM RETRACTOR SYSTEM (ALUMINUM ALLOY) Pro-Med Instruments GmbH HBL Class II 2003-11-20
K032935 EPI-SCAN, MODEL P 100 Edx Epi-Scan, Inc. GZO Class II 2003-11-20
K022304 ACCUMAP AUTOMATIC PERIMETER Objectivision Pty , Ltd. GWE Class II 2003-11-14
K033358 CHRONIC PAIN SUPPRESSOR CPS-2000, MODEL CPS-2000 Surgitech, Inc. LIH Class II 2003-11-14
K031546 RAINBOW GT-4A PAIN RELIEF MACHINE Sino-Us Information, Inc. GZJ Class II 2003-11-13
K021594 COPC BAND Center For Orthotic and Prosthetic Care,Llc MVA Class II 2003-11-13
K013452 DANMAR PRODUCTS CRANIAL ADJUSTIVE PROSTHESIS Danmar Products, Inc. MVA Class II 2003-10-31
K032388 BONE CEMENT RADIO-OPACIFIER Cardinalhealth MYU Class II 2003-10-31
K032366 BONESOURCE HAC FAST SETTING CEMENT Stryker Instruments GXP Class II 2003-10-30
K033016 PISCES Z QUAD LEAD MODEL, 3890, PISCES Z QUAD COMPACT LEAD MODEL, 3891, PISCES Z QUAD PLUS LEAD MODEL, 3892 Medtronic Neurological GZB Class II 2003-10-30
K032307 CAP BONE SUBSTITUTE MATERIAL Etex Corp. GXP Class II 2003-10-24
K032590 MICROPLEX COIL SYSTEM (MCS), HYDROCOIL EMBOLIC SYSTEM (HES) MicroVention, Inc. HCG Class II 2003-10-22
K032917 NAVITRACK SYSTEM - TOTAL HIP REPLACEMENT CT-FREE Orthosoft, Inc. HAW Class II 2003-10-21
K033253 S21 TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR Micro Current Technology, Inc. GZJ Class II 2003-10-21
K032337 HEMEDEX CRANIAL BOLT MODELS, 3601, 3602 Hemedex Incorporated GWM Class II 2003-10-21
K031732 EBI ACUMEN SURGICAL NAVIGATION SYSTEM Ebi, L.P. HAW Class II 2003-10-15
K030468 ACURA ELITE GRAVITY COMPENSATING RESERVOIR Phoenix Biomedical Corp. JXG Class II 2003-10-15
K032115 NEUROLAC NERVE GUIDE MODELS NG01-15/03, NG01-020/03, NG01 025/03, NG01-030/03 Polyganics B.V., JXI Class II 2003-10-10
K030737 OMEGA WHOLE-CORTEX MFG SYSTEM, MODELS OMEGA 151, OMEGA 275 Ctf Systems (2001), Inc. OLX Class II 2003-10-10
K033010 BRM2 BRAIN MONITOR Brainz Instruments , Ltd. OLT Class II 2003-10-10
K032196 NBD DISPOSABLE RF CANNULAE New Business Development, LLC GXI Class II 2003-10-09
K032817 EXTERNAL DRAINAGE SET Integra Neurosciences Implants S.A. JXG Class II 2003-10-06
K032751 MODIFICATION TO RENEW LEAD EXTENSION Advanced Neuromodulation Systems GZB Class II 2003-10-06
K030081 CSF400 AND CSF600 Inmed Ltda. JXG Class II 2003-10-06
K032349 PLACER Advanced Neuromodulation Systems GZB Class II 2003-10-03
K032034 ANS AXXESS PERCUTANEOUS LEAD Advanced Neuromodulation Systems GZB Class II 2003-10-03
K032055 MEDS-4-INF+ Medical Equipment Device Specialists GZJ Class II 2003-10-03
K032693 DURAGEN PLUS DURAL GRAFT MATRIX Integra Lifesciences Corp. GXQ Class II 2003-09-30
K032497 SAPPHIRE VDS TENSION SAFE DETACHABLE COIL, E-3-12/3-T10-VT Micro Therapeutics, Inc. HCG Class II 2003-09-25
K032833 MYOSYSTEM WITH CUSTOMIZING Otto Bock Healthcare LP GXY Class II 2003-09-23
K032553 TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE, ALSO KNOWN AS TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM Cordis Neurovascular, Inc. HCG Class II 2003-09-23
K032707 CONTOUR SE MICROSPHERES (SYRINGE) Boston Scientific Corp HCG Class II 2003-09-23
K032542 MODIFICATION TO CONTOUR SE MICROSPHERES Boston Scientific Corp HCG Class II 2003-09-16
K031337 ACUMEN SURGICAL NAVIGATION SYSTEM Biomet, Inc. HAW Class II 2003-09-15
K032054 RADIONICS NASHOLD BIOPSY NEEDLE - SINGLE USE Radionics, A Division of Tyco Healthcare Group LP HAW Class II 2003-09-15
K032653 E275 Micro Current Technology, Inc. GZJ Class II 2003-09-12
K030564 THERMOSKIN CONDUCTIVE PADS United Pacific, Inc. GXY Class II 2003-09-12
K032561 RESUME II LEAD KIT FOR SPINAL CORD STIMULATION (SCS) AND PERIPHERAL NERVE STIMULATION (PNS), RESUME TL LEAD KIT FOR Medtronic Vascular GZB Class II 2003-09-11
K031850 DURASIS DURAL SUBSTITUTE Cook Biotech, Inc. GXQ Class II 2003-09-08
K031694 MODIFICATION TO EEG MONITOR WITH BIS, MODEL A-2000 Aspect Medical Systems, Inc. OLW Class II 2003-08-29
K023913 NEUROTECH BAXOLVE TYPE 294 Bio-Medical Research, Ltd. GZJ Class II 2003-08-25
K031885 NAVIGUS PASSIVE HEAD RESTRAINT SYSTEM, MODEL HR-XXX Image-Guided Neurologics, Inc. HBL Class II 2003-08-21
K031852 SAPPHIRE DETACHABLE FIBER COILS Micro Therapeutics, Inc. HCG Class II 2003-08-20
K032198 AESCULAP YASARGIL ANEURYSM CLIP PHYNOX BOOSTER CLIP Aesculap, Inc. HCH Class II 2003-08-20
K031770 CI TKR/UKR Brainlab AG HAW Class II 2003-08-12
K024359 VISTA SCIENTIFIC BARIUM SULFATE, MODEL 3001-1 Vista Scientific, LLC MYU Class II 2003-08-08
K031900 HANDMASTER Ness-Neuromuscular Electrical Stimulation Systems GZI Class II 2003-08-08
K031654 SYNTHES RESORBABLE CRANIAL CLAMP, (MODIFIED) Synthes (Usa) GXR Class II 2003-08-08
K030517 BALL RECORDING ELECTRODE/STIMULATION PROBE Viasys Healthcare, Inc. GZK Class II 2003-08-01
K031578 MICRUS MICROCOIL SYSTEMS, MODELS HEL, SPH, STR, FSR AND HSR Micrus Corp. HCG Class II 2003-08-01
K031049 GUGLIELMI DETACHABLE COIL (GDC) Boston Scientific, Target HCG Class II 2003-08-01
K031999 ELEKTA LEKSELL STEREOTACTIC SYSTEM WITH MR POST KIT Elekta Instrument AB HAW Class II 2003-07-25
K031980 MODIFICATION TO LEKSELL STEREOTACTIC SYSTEM Elekta Instrument AB HAW Class II 2003-07-25
K024377 TRANSCRANIAL ELECTROTHERAPY STIMULATOR-A, MODEL TESA-1 Kalaco Scientific, Inc. QJQ Class II 2003-07-21
K030392 SAPPHIRE DETACHABLE COIL SYSTEM Micro Therapeutics, Inc. HCG Class II 2003-07-21
K030669 PROVIDENCE MOLDING HELMET Northeast Orthotics and Prothetics, Inc. MVA Class II 2003-07-18
K031482 CRYOSTAR SYSTEM, COMPRISING: A) CRYOSTAR CONSOLE, B) CRYOSTAR 1MM CRYOPROBE, C) CRYOSTAR 2MM CRYOPROBE, D) CONVENIENCE Cryomedical Instruemts , Ltd. GXH Class II 2003-07-10
K023355 ASYRA Galloway Technologies, LLC GZO Class II 2003-06-24
K031468 TEMPORARY TITANIUM ANEURYSM CLIP Cardinalhealth HCH Class II 2003-06-20
K030963 TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE, ALSO KNOWN AS THE TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM Cordis Neurovascular, Inc. HCG Class II 2003-06-20
K023726 TENS PRO 900 Acumed Medical Supplies , Ltd. GZJ Class II 2003-06-17
K030887 LEKTROGEL, MODEL LK3001 Inmed Ltda. GYB Class II 2003-06-13
K030800 ELECTROMED REUSABLE NEUROSTIMULATION ELECTRODES Eletromed, Inc. GXY Class II 2003-06-11
K024192 VECTORVISION FLUORO3D Brainlab AG HAW Class II 2003-06-11
K030332 MODIFICATION TO BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000 Bionicare Medical Technologies, Inc. NYN Class II 2003-06-06
K031303 AESCULAP-MIETHKE SHUNT SYSTEM GRAVITY ASSISTED VALVE (GAV) Aesculap, Inc. JXG Class II 2003-06-04
K022579 STRYKER NAVIGATION SYSTEM-KNEE MODULE Stryker Leibinger HAW Class II 2003-06-02
K030827 NAVITRACK SYSTEM: TOTAL HIP REPLACEMENT CT-FREE CUP, MODEL 900.204 Orthosoft, Inc. HAW Class II 2003-05-23
K031034 SPIN DOWN RAPIDFLAP Walter Lorenz Surgical, Inc. GXN Class II 2003-05-21
K022849 BODY CLOCK TENS N' TONE Body Clock Health Care, Ltd. GZJ Class II 2003-05-20
K031069 SURGISIS NERVE CUFF Cook Biotech, Inc. JXI Class II 2003-05-15
K031086 CAMINO SINGLE PARAMETER MONITOR, MODEL SPM-1 Integra Neurosciences GWM Class II 2003-05-14
K031149 OLYMPIC CFM 6000 Olympic Medical Corp. OMA Class II 2003-05-14
K031123 CODMAN BACTISEAL BARIUM STRIPED CATHETERS Codman & Shurtleff, Inc. HCA Class II 2003-05-14

6,130 clearances in the Neurology panel. Data: openFDA.