Atlas FDA

Neurology

6,099 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
NEURO-ENDOSCOPE SYSTEM BY HOPF, EXISTING OF: ENDOSCOPES, SHEATHS, WORKING ELEMENTS, BIPOLAR AND UNIPOLAR ELECTRODES (K031858)Richard Wolf Medical Instruments Corp.2004-07-29
DUREPAIR DURA REGENERATION MATRIX (K041000)Medtronic Neurosurgery2004-07-27
ELEKTA MICRODRIVE, MODEL 916716 (K040979)Elekta Instrument AB2004-07-23
PHYSICIAN INDUSTRIES RADIOFREQUENCY ABLATION NEEDLE (K040565)Physician Industries, Inc.2004-07-22
FENZIAN TREATMENT SYSTEM (K041575)Eumedic Limited2004-07-16
ACTIGRAPH, MODEL AM7164-2.2 AND ACTIGRAPH WITH EXTENDED MEMORY, MODEL AM71256 (K040554)Manufacturing Technology, Inc.2004-07-16
NEURA WRAP NERVE PROTECTOR (K041620)Integra Lifesciences Corp.2004-07-16
SAPPHIRE NXT DETACHABLE COIL SYSTEM (K041649)Micro Therapeutics, Inc.2004-07-16
ACUMEN SURGICAL NAVIGATION SYSTEM (K031454)Biomet, Inc.2004-07-08
SYNTHES (USA) CHRONOS (K041350)Synthes (Usa)2004-07-08
INTERFERENTIAL STIMULATOR, MODEL BMLS02-6 (K040007)Biomedical Life Systems, Inc.2004-07-07
MODIFICATION TO: HYDROCOIL EMBOLIC SYSTEM (HES) (K041551)MicroVention, Inc.2004-07-07
BIS PEDIATRIC SENSOR (K041670)Aspect Medical Systems, Inc.2004-07-06
CADWELL LIMB MOVEMENT MODULE (K040986)Cadwell Laboratories, Inc.2004-07-01
FAST START TENS, MODEL FS 3001 (K041092)Vision Quest Industries, Inc.2004-07-01
EASYNET BODY POSITION MODULE (K040932)Cadwell Laboratories, Inc.2004-07-01
CODMAN DURAFORM DURAL GRAFT IMPLANT (K041518)Codman & Shurtleff, Inc.2004-06-22
NAVITRACK SYSTEM - S&N IMAGE FREE HIP, MODEL PRO-03017 (K041369)Orthosoft, Inc.2004-06-22
SYNTHES (USA) PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANTS (K033868)Synthes (Usa)2004-06-21
CRANIOFIX AND CRANIOFIX2 TITANIUM CLAMP SYSTEM (K040864)Aesculap2004-06-17
MEDTRONIC PS MEDICAL STRATA VALVE (K040943)Medtronic Neurosurgery2004-06-15
MODIFICATION TO HAKIM PRECISION VALVE SYSTEM, HAKIM PROGRAMMABLE VALVE SYSTEM, HAKIM MICRO PROGRAMMABLE VALVE SYSTEM, SI (K041296)Codman & Shurtleff, Inc.2004-06-10
NAVIGUS PASSIVE PROBE (BL), MODEL NP-2000 (K040834)Image-Guided Neurologics, Inc.2004-06-03
NIC36 AMPLIFIER (K041198)Eb Neuro S.P.A.2004-06-01
LIMITED FUNCTION WL/OTC-TENS DEVICE, MODEL WL-2103A, WL-2203A, WL-2203B AND WL-2401 (K040512)Well-Life Healthcare, Inc.2004-05-27
MODIFICATION TO LUMBO-PERITONEAL SHUNTS AND LUMBAR DRAINAGE CATHETERS (K033704)Vygon Us, LLC2004-05-27
ISURG DISPOSABLE SUBDERMAL NEEDLE ELECTRODE (K040639)Isurgical2004-05-21
L-TENS (K041164)Fuji Dynamics Limited2004-05-20
BONE CEMENT FOR CRANIOPLASTY (K040152)Cardinalhealth2004-05-19
ENVOY PATIENT MONITOR (K024245)Mennen Medical , Ltd.2004-05-10
INTERFERENTIAL STIMULATOR, MODEL BMLS03-6 (K040824)Biomedical Life Systems, Inc.2004-04-29
MODEL GST-1 (K040193)Medical Equipment Device Specialists2004-04-27
LICOX PMO BRAIN MONITORING SYSTEM (K040235)Integra LifeSciences Corporation2004-04-20
BMR NEUROTECH BACK TENS AND LUMBAR SUPPORT DEVICE. TYPE 294 (K023916)Bio-Medical Research, Ltd.2004-04-15
ANSPACH MRI SAFE SURGICAL DRILL SYSTEM (K040186)The Anspach Effort, Inc.2004-04-15
EASY MED TN-28 C (K040253)Easy Med Instrument Co., Ltd.2004-04-08
PHOENIX INFUSION CATHETER (K033017)Phoenix Biomedical2004-04-07
STRYKER RF ELECTRODES AND CANNULAE (K032406)Stryker Instruments2004-04-01
STRYKER INTERVENTIONAL PAIN RF GENERATOR (K032601)Valley Forge Scientific Corp.2004-04-01
AESCULAP ABSORBABLE CRANIOFIX (K040080)Aesculap, Inc.2004-03-31
RETISCAN, RETIPORT (K023525)Roland Consult2004-03-26
POLYETHER URETHANE MATERIAL CHANGE IN NEUROSTIMULATION LEADS (K040568)Medtronic Vascular2004-03-25
MODIFICATION TO SAPPHIRE DETACHABLE COIL SYSTEM (TETRIS 3-D) (K040694)Micro Therapeutics, Inc.2004-03-25
RAPID PROGRAMMER (K040609)Advanced Neuromodulation Systems2004-03-25
MEGVISION, MODEL EQ1000C SERIES (K040051)Eagle Technology, Inc.2004-03-24
MICRO TARGETING ELECTRODE (K033173)FHC, Inc.2004-03-24
ALICE 5 (K040595)Respironics, Inc.2004-03-18
SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE (K034012)Smith & Nephew, Inc.2004-03-16
ANSPACH ADVANCED MICRO SAW ATTACHMENTS (K040076)The Anspach Effort, Inc.2004-03-15
EMU128S, MODEL EX-NW-128S (K040360)Excel Tech. , Ltd.2004-03-12
NAVIPRO KNEE SOFTWARE MODULE (K033668)Kinamed, Inc.2004-03-11
AMBU NEUROLINE SINGLE PATIENT EEG/EP CUP ELECTRODE (K032278)Ambu, Inc.2004-03-05
HIGH SPEED EMG MODULE (K031930)Medical Measurement Systems B.V.2004-03-03
NAVIGUS UNIBODY FIDUCIAL MARKER SYSTEM, MODEL FM-4000 (K033619)Image-Guided Neurologics, Inc.2004-03-02
POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM MODES SPV, SPVA, SPVB (K031097)Sophysa SA2004-02-26
MODIFICATION TO BURR HOLE VALVE AND SHUNT SYSTEM (K040201)Integra Neurosciences Implants S.A.2004-02-26
CODMAN DURAL GRAFT IMPLANT, MODELS 80-1471, 80-1472, 80-1473, 80-1474, 80-1475, 80-1476, 80-1477, 80-1478, 80-1480, 80-1 (K033395)Codman & Shurtleff, Inc.2004-02-25
BISX (K040183)Aspect Medical Systems, Inc.2004-02-25
SMARTEP-ASSR, MODEL M811007 (K031051)Intelligent Hearing Systems2004-02-20
SANDMAN SD20 AMPLIFIER (K040113)Eb Neuro S.P.A.2004-02-18
ADAM (K033978)Astro-Med, Inc.2004-02-18
ZIMMER ORTHO GUIDANCE SYSTEMS- HIP INSTRUMENTS (K033223)Zimmer, Inc.2004-02-18
VECTORVISION CRANIAL/ENT (K023651)Brainlab AG2004-02-17
MICROSTAT PVA FOAM EMBOLIZATION PARTICLES (K032619)Surgica Corp.2004-02-13
ZIMMER ORTHO GUIDANCE SYSTEMS- KNEE INSTRUMENTS (K033011)Zimmer, Inc.2004-02-12
LEKSELL SURGIPLAN WITH IMAGEMERGE (K033340)Elekta Instrument AB2004-02-12
SEDLINE WITH FRONTAL PSI (K033999)Physiometrix, Inc.2004-02-06
GELSPHERES / BEADBLOCK COMPRESSIBLE MICROSPHERES (K033761)Biocompatibles UK Limited2004-02-04
MICRUS MODIFIED MICROCOIL SYSTEM, CERECYTE (K033813)Micrus Corp.2004-02-04
MTS MULTIPROGRAM TRIAL STIMULATOR SYSTEM (K033757)Advanced Neuromodulation Systems2004-01-30
NDI PASSIVE SPHERES (K033621)Northern Digital, Inc.2004-01-27
STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM (K032303)Stryker Instruments2004-01-16
EEG MONITOR WITH BIS, MODEL A-2000 (K030267)Aspect Medical Systems, Inc.2004-01-15
ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS03-5 (K033455)Biomedical Life Systems, Inc.2004-01-15
MEDTRONIC PS MEDICAL STRATA NSC VALVE AND SHUNT ASSEMBLIES WITH AND WITHOUT BIOGLIDE (K033850)Medtronic Neurosurgery2004-01-13
SAPPHIRE DETACHABLE FIBERED COIL SYSTEM, HELIX FIBERED, CYCLONE, MULTIPLE MODELS (K033372)Micro Therapeutics, Inc.2004-01-09
STORZ RANEY SCALP CLIP, MODEL 1-20-004-05 (K033660)Rudolf Storz GmbH2004-01-07
PREMIER PLUS (K032003)American Imex2004-01-07
SPINEASSIST DEVICE (K033413)Mazor Surgical Technologies , Ltd.2004-01-07
WIRELESS INPUT UNIT, MODEL WEE-1000A SERIES (K033475)Nihon Kohden America, Inc.2004-01-07
HYDROCOIL EMBOLIC SYSTEM (HES) (K033836)MicroVention, Inc.2003-12-30
T-TECH DIGITAL, MODEL WL-22XXA SERIES (K033857)Well-Life Healthcare, Inc.2003-12-19
MEDIPHYSICS PAIN TREATMENT SYSTEM, MODEL 1 (K032928)Mediphysics Pain Centers of America2003-12-19
CONDUCTIVE EEG ELECTROLYTE (K033052)Compumedics USA, Ltd.2003-12-17
CONTOUR-FLEX VALVE AND SHUNT SYSTEM (K033698)Integra Neurosciences Implants S.A.2003-12-17
GM3 SERIES HV TENS, MODEL GM3X3HV (WHERE X IS PARAMETER OF DIFFERENT HOUSING) (K032994)Gemore Technology Co, Ltd.2003-12-16
EPOCHXP NEUROLOGICAL WORKSTATION,EPOCHXP LITE NEUROLOGICAL WORKSTATION (K032741)Axon Systems, Inc.2003-12-16
TRACERS TA BONE CEMENT OPACIFIER, MODEL TCR-TA (K033230)Parallax Medical, Inc.2003-12-12
GM3 SERIES IF TENS, MODEL GM3X2IF (WHERE X IS A PARAMETER OF DIFFERENT HOUSING) (K032719)Gemore Technology Co, Ltd.2003-12-10
GEM-STIM TENS, MODELS GM3XY AND GM3AXY (K032720)Gemore Technology Co, Ltd.2003-12-10
ACRA-CUT XPRESS 120 (K032970)Acra Cut, Inc.2003-12-08
VPT METER (K030829)Xilas Medical, Inc.2003-12-05
LAMITRODE SPINAL CORD STIMULATION LEADS (K033429)Advanced Neuromodulation Systems2003-12-04
MICRUS MICROCOIL SYSTEM (K032872)Micrus Corp.2003-11-28
BESMED VARIOUS MODELS OF TENS, BE-550/BE-660 (K031374)Besmed Health Business Corp2003-11-28
DORO RADIOLUCENT HEADREST SYSTEM AND HORSESHOE HEADRESTS,AND NON-RADIOLUCENT J-ARM RETRACTOR SYSTEM (ALUMINUM ALLOY) (K032331)Pro-Med Instruments GmbH2003-11-20
EPI-SCAN, MODEL P 100 (K032935)Edx Epi-Scan, Inc.2003-11-20
CHRONIC PAIN SUPPRESSOR CPS-2000, MODEL CPS-2000 (K033358)Surgitech, Inc.2003-11-14
ACCUMAP AUTOMATIC PERIMETER (K022304)Objectivision Pty , Ltd.2003-11-14
COPC BAND (K021594)Center For Orthotic and Prosthetic Care,Llc2003-11-13
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