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Neurology

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

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RecordFirmDate
RAINBOW GT-4A PAIN RELIEF MACHINE (K031546)Sino-Us Information, Inc.2003-11-13
BONE CEMENT RADIO-OPACIFIER (K032388)Cardinalhealth2003-10-31
DANMAR PRODUCTS CRANIAL ADJUSTIVE PROSTHESIS (K013452)Danmar Products, Inc.2003-10-31
PISCES Z QUAD LEAD MODEL, 3890, PISCES Z QUAD COMPACT LEAD MODEL, 3891, PISCES Z QUAD PLUS LEAD MODEL, 3892 (K033016)Medtronic Neurological2003-10-30
BONESOURCE HAC FAST SETTING CEMENT (K032366)Stryker Instruments2003-10-30
CAP BONE SUBSTITUTE MATERIAL (K032307)Etex Corp.2003-10-24
MICROPLEX COIL SYSTEM (MCS), HYDROCOIL EMBOLIC SYSTEM (HES) (K032590)MicroVention, Inc.2003-10-22
HEMEDEX CRANIAL BOLT MODELS, 3601, 3602 (K032337)Hemedex Incorporated2003-10-21
S21 TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR (K033253)Micro Current Technology, Inc.2003-10-21
NAVITRACK SYSTEM - TOTAL HIP REPLACEMENT CT-FREE (K032917)Orthosoft, Inc.2003-10-21
ACURA ELITE GRAVITY COMPENSATING RESERVOIR (K030468)Phoenix Biomedical Corp.2003-10-15
EBI ACUMEN SURGICAL NAVIGATION SYSTEM (K031732)Ebi, L.P.2003-10-15
NEUROLAC NERVE GUIDE MODELS NG01-15/03, NG01-020/03, NG01 025/03, NG01-030/03 (K032115)Polyganics B.V.,2003-10-10
OMEGA WHOLE-CORTEX MFG SYSTEM, MODELS OMEGA 151, OMEGA 275 (K030737)Ctf Systems (2001), Inc.2003-10-10
BRM2 BRAIN MONITOR (K033010)Brainz Instruments , Ltd.2003-10-10
NBD DISPOSABLE RF CANNULAE (K032196)New Business Development, LLC2003-10-09
CSF400 AND CSF600 (K030081)Inmed Ltda.2003-10-06
MODIFICATION TO RENEW LEAD EXTENSION (K032751)Advanced Neuromodulation Systems2003-10-06
EXTERNAL DRAINAGE SET (K032817)Integra Neurosciences Implants S.A.2003-10-06
PLACER (K032349)Advanced Neuromodulation Systems2003-10-03
MEDS-4-INF+ (K032055)Medical Equipment Device Specialists2003-10-03
ANS AXXESS PERCUTANEOUS LEAD (K032034)Advanced Neuromodulation Systems2003-10-03
DURAGEN PLUS DURAL GRAFT MATRIX (K032693)Integra Lifesciences Corp.2003-09-30
SAPPHIRE VDS TENSION SAFE DETACHABLE COIL, E-3-12/3-T10-VT (K032497)Micro Therapeutics, Inc.2003-09-25
CONTOUR SE MICROSPHERES (SYRINGE) (K032707)Boston Scientific Corp2003-09-23
TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE, ALSO KNOWN AS TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM (K032553)Cordis Neurovascular, Inc.2003-09-23
MYOSYSTEM WITH CUSTOMIZING (K032833)Otto Bock Healthcare LP2003-09-23
MODIFICATION TO CONTOUR SE MICROSPHERES (K032542)Boston Scientific Corp2003-09-16
ACUMEN SURGICAL NAVIGATION SYSTEM (K031337)Biomet, Inc.2003-09-15
RADIONICS NASHOLD BIOPSY NEEDLE - SINGLE USE (K032054)Radionics, A Division of Tyco Healthcare Group LP2003-09-15
THERMOSKIN CONDUCTIVE PADS (K030564)United Pacific, Inc.2003-09-12
E275 (K032653)Micro Current Technology, Inc.2003-09-12
RESUME II LEAD KIT FOR SPINAL CORD STIMULATION (SCS) AND PERIPHERAL NERVE STIMULATION (PNS), RESUME TL LEAD KIT FOR (K032561)Medtronic Vascular2003-09-11
DURASIS DURAL SUBSTITUTE (K031850)Cook Biotech, Inc.2003-09-08
MODIFICATION TO EEG MONITOR WITH BIS, MODEL A-2000 (K031694)Aspect Medical Systems, Inc.2003-08-29
NEUROTECH BAXOLVE TYPE 294 (K023913)Bio-Medical Research, Ltd.2003-08-25
NAVIGUS PASSIVE HEAD RESTRAINT SYSTEM, MODEL HR-XXX (K031885)Image-Guided Neurologics, Inc.2003-08-21
AESCULAP YASARGIL ANEURYSM CLIP PHYNOX BOOSTER CLIP (K032198)Aesculap, Inc.2003-08-20
SAPPHIRE DETACHABLE FIBER COILS (K031852)Micro Therapeutics, Inc.2003-08-20
CI TKR/UKR (K031770)Brainlab AG2003-08-12
HANDMASTER (K031900)Ness-Neuromuscular Electrical Stimulation Systems2003-08-08
VISTA SCIENTIFIC BARIUM SULFATE, MODEL 3001-1 (K024359)Vista Scientific, LLC2003-08-08
SYNTHES RESORBABLE CRANIAL CLAMP, (MODIFIED) (K031654)Synthes (Usa)2003-08-08
BALL RECORDING ELECTRODE/STIMULATION PROBE (K030517)Viasys Healthcare, Inc.2003-08-01
MICRUS MICROCOIL SYSTEMS, MODELS HEL, SPH, STR, FSR AND HSR (K031578)Micrus Corp.2003-08-01
GUGLIELMI DETACHABLE COIL (GDC) (K031049)Boston Scientific, Target2003-08-01
ELEKTA LEKSELL STEREOTACTIC SYSTEM WITH MR POST KIT (K031999)Elekta Instrument AB2003-07-25
MODIFICATION TO LEKSELL STEREOTACTIC SYSTEM (K031980)Elekta Instrument AB2003-07-25
SAPPHIRE DETACHABLE COIL SYSTEM (K030392)Micro Therapeutics, Inc.2003-07-21
TRANSCRANIAL ELECTROTHERAPY STIMULATOR-A, MODEL TESA-1 (K024377)Kalaco Scientific, Inc.2003-07-21
PROVIDENCE MOLDING HELMET (K030669)Northeast Orthotics and Prothetics, Inc.2003-07-18
CRYOSTAR SYSTEM, COMPRISING: A) CRYOSTAR CONSOLE, B) CRYOSTAR 1MM CRYOPROBE, C) CRYOSTAR 2MM CRYOPROBE, D) CONVENIENCE (K031482)Cryomedical Instruemts , Ltd.2003-07-10
ASYRA (K023355)Galloway Technologies, LLC2003-06-24
TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE, ALSO KNOWN AS THE TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM (K030963)Cordis Neurovascular, Inc.2003-06-20
TEMPORARY TITANIUM ANEURYSM CLIP (K031468)Cardinalhealth2003-06-20
TENS PRO 900 (K023726)Acumed Medical Supplies , Ltd.2003-06-17
LEKTROGEL, MODEL LK3001 (K030887)Inmed Ltda.2003-06-13
ELECTROMED REUSABLE NEUROSTIMULATION ELECTRODES (K030800)Eletromed, Inc.2003-06-11
VECTORVISION FLUORO3D (K024192)Brainlab AG2003-06-11
MODIFICATION TO BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000 (K030332)Bionicare Medical Technologies, Inc.2003-06-06
AESCULAP-MIETHKE SHUNT SYSTEM GRAVITY ASSISTED VALVE (GAV) (K031303)Aesculap, Inc.2003-06-04
STRYKER NAVIGATION SYSTEM-KNEE MODULE (K022579)Stryker Leibinger2003-06-02
NAVITRACK SYSTEM: TOTAL HIP REPLACEMENT CT-FREE CUP, MODEL 900.204 (K030827)Orthosoft, Inc.2003-05-23
SPIN DOWN RAPIDFLAP (K031034)Walter Lorenz Surgical, Inc.2003-05-21
BODY CLOCK TENS N' TONE (K022849)Body Clock Health Care, Ltd.2003-05-20
SURGISIS NERVE CUFF (K031069)Cook Biotech, Inc.2003-05-15
MATRIX STRETCH RESISTANT DETACHABLE COIL (K031168)Boston Scientific, Target2003-05-14
CODMAN BACTISEAL BARIUM STRIPED CATHETERS (K031123)Codman & Shurtleff, Inc.2003-05-14
OLYMPIC CFM 6000 (K031149)Olympic Medical Corp.2003-05-14
CAMINO SINGLE PARAMETER MONITOR, MODEL SPM-1 (K031086)Integra Neurosciences2003-05-14
STACKED ABR FOR NAVIGATOR PRO (K030907)Bio-Logic Systems Corp.2003-05-09
IGI-SYSTEM (K023424)Denx Advanced Dental Systems2003-05-09
AESCULAP NEURO PATTIES, NEUROSORB 4, 6, AND 75 (GREEN & WHITE) (K031008)Aesculap2003-05-09
NAVITRACK SYSTEM-FLUOROSPINE, MODEL 900.005 (K031156)Orthosoft, Inc.2003-05-09
SOFT-TOUCH TENS ELECTRODE (K030375)Pain Management Technologies2003-05-05
BIOMET CRANIOFACIAL ACRYLIC CEMENT (K011399)Biomet, Inc.2003-05-05
DIEGO POWERED DISSECTOR HANDPIECE WITH STARLINK IMAGE-GUIDED ADAPTER MOUNTING INTERFACE (K030343)Gyrus Ent LLC2003-05-02
BRM2 BRAIN MONITOR (K030489)Brainz Instruments , Ltd.2003-05-02
HIVOX DREAMATE DM-800 (K021952)Hivox Biotek, Inc.2003-05-02
MEDIPALM-20 (K031202)Braebon Medical Corp.2003-05-01
MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL (EP) SYSTEM (K031009)Bio-Logic Systems Corp.2003-04-28
FLEXIBLE RUBBER ELECTRODES, MODELS: 1460265, 1460272, 1460274, 3444128, 3444129, 3444130 (K030297)Enraf-Nonius, B.V.2003-04-28
A127 LEAD EXTENSION (K030461)Advanced Neuromodulation Systems2003-04-24
Z-BOX (K030764)Z-Kat, Inc.2003-04-24
CARE STIM (K022417)Care Rehab and Orthopaedic2003-04-10
ALGO 3I NEWBORN HEARING SCREENER (K030823)Natus Medical, Inc.2003-04-09
ELFCARE DEVICE, MODELS 314A THROUGH 314G (K023231)Mediseb , Ltd.2003-04-04
SMALL HIGH SPEED MOTOR DRILL SYSTEM (K030172)Brasseler USA I, L.P.2003-04-03
OSTEOMED CRANIAL FLAP FIXATION SYSTEM (K022277)Osteomed Corp.2003-04-01
MODIFICATION TO AXXESS SPINAL CORD STIMULATION LEAD (K030674)Advanced Neuromodulation Systems2003-03-28
AESULAP KOPITNIK AVM MICROCLIPS AND APPLIER (K024349)Aesculap, Inc.2003-03-24
ENDOSCOPE SET FOR MAGNETIC RESONANCE (MR), MODELS 8767.412, 8767.121 & 8767.452 (K022198)Richard Wolf Medical Instruments Corp.2003-03-21
DIGI-PRO TENS/WL-2203B,2204B,2204B-P1,2204B-P2,2205B (K030537)Well-Life Healthcare, Inc.2003-03-20
AESCULAP - MIETHKE SHUNT SYSTEM W/ NPH-DSV (K030698)Aesculap, Inc.2003-03-20
STRYKER LEIBINGER CRANIAL FIXATION SYSTEM (K030378)Stryker Instruments2003-03-20
IMAGELESS KNEE MODULE FOR THE STEALTHSTATION SYSTEM (K030552)Medtronic Surgical Navigation Technologies2003-03-19
LOW PROFILE EEG NEEDLE ELECTRODE, MODELS 112-812-18TP, 112-812-48TP, 112-812-60TP, 112-812-72TP, 112-812-96TP, 112-812 (K023472)Class A Enterprises, Inc.2003-03-18
DUOMED, SERIES 500, (MODELS ID 500, FL 500) (K030140)Duomed, Inc.2003-03-18
GDC STRETCH RESISTANT DETACHABLE COIL (K030475)Boston Scientific, Target2003-03-14
NAVIGUS FIDUCIAL MARKER SYSTEM, MODELS FM-1000, FM-2000 (K024201)Image-Guided Neurologics, Inc.2003-03-12
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