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Neurology

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

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RecordFirmDate
JIAJIAN SELF-ADHESIVE ELECTRODE (K090198)Wuxi Jiajian Medical Instrument Co., Ltd.2009-06-23
MICROPLEX COIL SYSTEM-COSMOS (K090891)MicroVention, Inc.2009-06-22
MAKO SURGICAL TACTILE GUIDANCE SYSTEM-HIP (K083644)Mako Surgical Corp.2009-06-19
NUVASIVE NEURO VISION SYSTEM (K090298)Nuvasive, Inc.2009-06-08
EMPI ACTIVE TRANSCUTANEOUS NERVE STIMULATOR (K090922)Empi2009-06-05
RS- LB LOW BACK CONDUCTIVE GARMENT, MODEL RS-LBM, RS-LBL, RS-FBG FULL BACK CONDUCTIVE GARMENT , MODEL RS-FBG (K090951)Rs Medical2009-06-05
PENTA LEAD KITS, MODELS: 3227-3234 (K090907)Advanced Neuromodulation Systems2009-06-02
CODMAN HAKIM MICRO II VALVE (K091346)Codman & Shurtleff, Inc.2009-06-02
CRANIAL ELECTRICAL NERVE STIMULATOR, MODEL FM 10/C (K090052)Johari Digital Healthcare , Ltd.2009-05-29
BLACKROCK NEUROPORT BIOPOTENTIAL SIGNAL PROCESSING SYSTEM (K090957)I2s Micro Implantable Systems, LLC2009-05-28
SMITH & NEPHEW PIGALILEO SCREW TARGETING SYSTEM V 1.0 (K090420)Smith & Nephew, Inc.2009-05-27
NEUROMETRIX BIOAMPLIFIER (K083322)Neurometrix, Inc.2009-05-27
FREEDOM STIM 100 AND 200 ELECTRODE AND LEADWIRE EXTENSION (K083441)Motion Medical Products, LLC2009-05-22
NEUCODIA (K081591)Verisci Corporation2009-05-15
CRANIAL IMAGE GUIDED SURGERY SYSTEM (K082060)Brainlab AG2009-05-08
FLEX-TENS (K090717)Emsi2009-05-08
PMT SUBDURAL CORTICAL ELECTRODES (K082474)Pmt Corp.2009-05-08
PAINMASTER MCT PATCH (K090042)Newmark, Inc.2009-05-06
GIMMI ANEURYSM CLIPS AND APPLYING FORCEPS (K081640)Gimmi GmbH2009-05-06
LASER TOUCHONE (K083822)Laser Health Technologies, LLC2009-05-06
LEKSELL STEREOTACTIC SYSTEM WITH REUSABLE FIXATION SCREWS (K080355)Elekta Instrument AB2009-05-01
PRIMADO (K083112)Nakanishi, Inc.2009-04-29
DINKLER SURGICAL SKULL CLAMP, MODEL 0308 (K090695)Dinkler Surgical Devices, Inc.2009-04-23
TENS/NMES/FES STIMULATING ELECTRODE (K083350)Covidien LP2009-04-21
MAYFIELD INFINITY XR2 SKULL CLAMP, MODEL A-2114 (K090506)Integra LifeSciences Corporation2009-04-20
HYDROFRAME (HES) (K090357)MicroVention, Inc.2009-04-10
WELL LIFE SELF ADHESIVE ELECTRODE / MODELS: CM, FA, PU AND SP (K082065)Well-Life Healthcare Limited2009-04-10
BRAINLAB HIP UNLIMITED, CI HIP UNLIMITED (K083483)Brainlab AG2009-04-08
SPINE & TRAUMA ICT (K083310)Brainlab AG2009-04-01
MIDAS REX MR7 PNEUMATIC HIGH SPEED SYSTEM, MODELS PM700, PM710, PC700, PC710, PC720, PA700 (K090112)Medtronic Powered Surgical Solutions2009-03-26
ACTICARE IC AND TSE (K081835)Bioinduction Limited2009-03-19
SPETZLER SCALP RETRACTOR CLAMPS (VARIOUS STYLES AND SIZES) (K090272)Cardinal Health, Inc.2009-03-18
AZUR DETACTABLE 18, MODELS 45-480305, 45-480310, 45-480405, 44-480415 (K090168)MicroVention, Inc.2009-03-12
BAXOLVE XP CONDUCTIVE GARMENT ACCESSORY & LUMBAR SUPPORT KIT, MODELS 297, 298 (K082190)Bio-Medical Research, Ltd.2009-03-11
PIGALILEO TKR BASE V2.3 AND CAS V4.1 (K090313)Smith & Nephew, Inc.2009-03-11
EVOX ELECTRO DIAGNOSTIC DEVICE (K082614)Laborie Medical Technologies, Inc.2009-03-06
V-GRIP PLUS DETACHMENT CONTROLLER, MODEL VG503 (K090001)MicroVention, Inc.2009-03-05
CODMAN BACTISEAL EVD CATHETER SET, CODMAN BACTISEAL CLEAR EVD CATHETER SET (K090348)Codman & Shurtleff, Inc.2009-03-04
NIM 3.0 (K083124)Medtronic Xomed, Inc.2009-02-27
DX6605E-TENS, DX6605E-G, DX6609-G (K082057)Shenzhen Dongdixin Technology Co., Ltd.2009-02-26
NAVIGATION PROBES (K082404)We Sense, Ltd.2009-02-25
SCRAMBLER ST 5 TENS DEVICE (K081255)Competitive Technologies,Inc.2009-02-20
PIGALILEO TOTAL HIP REPLACEMENT (THR) SOFTWARE APPLICATION V3.0 (K083565)Smith & Nephew, Inc.2009-02-20
ICS CHARTR EP 200 (K083399)Gn Otometrics A/S2009-02-20
ORTHO-MAP-ONCOLOGY NAVIGATION SOFTWARE, MODELS 6005-650-000, 6005-651-000 (K083009)Stryker Leibinger GmbH & Co KG2009-02-19
TENSCARE ITOUCH MODEL(S) EASY AND PLUS (K082377)Tenscare, Ltd.2009-02-09
TENS-EMS-14 (K083030)Emsi2009-02-05
IF SERIES TRUE SINE INTERFERENTIAL STIMULATOR, MODEL: WL-2206B AND WL-2106E (K090023)Well-Life Healthcare Limited2009-01-30
MAICO MB 11 WITH BERAPHONE PROBE (K082035)Maico Diagnostics2009-01-29
CAMLAB CRANIAL ORTHOSIS HELMET (K081787)Biosculptor Corporation2009-01-27
PRO-TECH DELIVERY SYSTEM ELECTRODES, MODEL TT-2000 (K081279)Transfer Technology2009-01-23
UNIVERSAL ELECTRODES (K083818)Neurometrix, Inc.2009-01-21
IMNS MEDACTA NAVIGATION SYSTEM (K083872)Medacta International S.A.2009-01-15
PAIN VISION, MODEL PS-2100 (K072882)Osachi Co., Ltd.2009-01-08
ULTIMA FIVE (K083494)Pain Management Technologies2009-01-06
MICRUS MICROCOLI SYSTEM, DELTAPLUSH, MODELS CPL, DPL (K083646)Micrus Endovascular Corporation2009-01-02
NICOLET CORTICAL STIMULATOR (K072964)Cardinal Health, Inc.2008-12-30
STRYKER DISPOSABLE CRANIAL PERFORATOR BIT (K082010)Stryker Ireland Ltd., Instruments Division2008-12-29
TWIN NEUROTRAC-III (K081551)Astro-Med, Inc.2008-12-24
CRANIAL PERFORATOR (K082637)The Anspach Effort, Inc.2008-12-22
BIS INTERFACE FOR VITALOGIK PATIENT MONITORS (K083063)Mennen Medical , Ltd.2008-12-16
NEUROSTAR TMS THERAPY SYSTEM, MODEL 1.1 (K083538)Neuronetics2008-12-16
COMBOCARE 2000 (K083202)Xanacare Technologies, LLC2008-12-15
RUGALIFT, MODEL# V.2.1 (K071573)Fatrotek S.R.L.2008-12-09
MAGSTIM DOUBLE 70MM AIR FILM COIL, MODEL 3910-00 (K080499)The Magstim Company , Ltd.2008-12-08
STARBAND (K082950)Orthomerica Products, Inc.2008-12-05
MEDISTIM XP, TYPE 281 AND MEDITENS XP, TYPE 458 (K082011)Bio-Medical Research, Ltd.2008-11-28
GE ENTROPY SENSOR (K082540)GE Healthcare2008-11-28
MAKO SURGICAL TACTILE GUIDANCE SYSTEM VERSION 2.0 (K081867)Mako Surgical Corp.2008-11-25
STRATA BURR HOLE VALVE, MODEL 42836 AND STRATA BURR HOLE SHUNT ASSEMBLY, MODEL 46836 (K083076)Medtronic Neurosurgery2008-11-20
TOP NEUROPOLE NEEDLE, MODEL SH, BL, SC, TC (K080771)Top Corp.2008-11-10
OSV II (K081773)Integra Neurosciences Implants S.A.2008-11-06
COMPONENT NEUROMONITORING SYSTEM (K080217)Moberg Research, Inc.2008-11-05
STARLIGHT (K082945)Orthomerica Products, Inc.2008-10-31
NEUROLINK IP, MODEL PK1113 (K081741)Excel-Tech Ltd. (Xltek)2008-10-31
PIGALILEO CAS, VERSION 4.0 AND TKR BASE, VERSION 2.1 (K082267)Smith & Nephew, Inc.2008-10-29
TENS/EMS COMBO, EMS, TENS (K082514)Medihightec Medical Co., Ltd.2008-10-21
ELECTRIC DRILL SYSTEM [XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONSOLE (IPC)] (K081475)Medtronic Xomed, Inc.2008-10-17
MICRUS MICROCOIL DELIVERY SYSTEM (K082739)Micrus Endovascular Corporation2008-10-17
COSMAN G4 RADIOFREQUENCY GENERATOR, MODEL RFG-4 (K082051)Cosman Medical, Inc.2008-10-16
COSMAN RF INJECTION ELECTRODES, MODELS CU, CUR, CCD, TCD, CP, CR, CN (K082012)Cosman Medical, Inc.2008-10-14
AURAGEN CORTICAL SURFACE ELECTRODES (K082250)Integra Neurosciences2008-10-10
MAYFIELD MR/X-RAY SKULL CLAMP (K081401)Integra Lifesciences Corp.2008-10-08
NEUROSTAR TMS SYSTEM (DEN070003)Neuronetics2008-10-07
SEN-4100 ELECTRIC STIMULATOR (K071969)Nihon Kohden America, Inc.2008-10-06
BARE PLATINUM FRAMING COIL, MODEL(S) 100408BPFC-V,100412BPFC-V,100515BPFC-V100518BPFC-V,100522BPFC-V,100618BPFC-V100622B (K082461)MicroVention, Inc.2008-10-02
UNIVERSAL ELECTRODES (K081871)Neurometrix, Inc.2008-09-29
L-ANEURYSM-CLIP SYSTEM & L-ANEURYSM CLIP APPLIERS, YASARGIL ANEURYSM CLIPS & YASARGIL ANEURYSM CLIP APPLIERS (K081489)Peter Lazic GmbH2008-09-25
TRUFILL DCS SYRINGE (K082324)Cordis Neurovascular, Inc.2008-09-12
STARLIGHT (K081994)Orthomerica Products, Inc.2008-09-12
EA STIMULATOR (K080221)Helio Medical Supplies, Inc.2008-09-09
COMPUMEDICS NEUVO (K081151)Compumedics USA, Ltd.2008-09-08
BRAINLAB KNEE ESSENTIAL, BRAINLAB KNEE UNLIMITED CI KNEE, CI KNEE UNLIMITED (K073615)Brainlab AG2008-09-05
NUTRITONE FACIAL BEAUTY SYSTEM (K070250)Isomers Laboratories, Inc.2008-09-04
NIHON KOHDEN EEG-1200A SERIES NEUROFAX, MODEL EEG-1200A (K080546)Nihon Kohden America, Inc.2008-08-29
COMBOCARE 2000 (K081141)Xanacare Technologies, LLC2008-08-29
STRATA NSC BURR HOLE VALVE, MODEL 42335; SHUNT ASSEMBLY, MODEL 46635 (K082127)Medtronic Neurosurgery2008-08-27
MOFICATION TO: MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY FIXATION (K082175)Bioplate, Inc.2008-08-13
NEUROCATH AG (K081942)Vygon Neuro2008-08-12
INSTRUMED RONGEUR (K081651)Instrumed International, Inc.2008-08-08
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