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Neurology

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

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RecordFirmDate
OSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTOR (K123885)Osteomed LP2013-06-03
MR CONDITIONAL CUP ELECTRODE, MR CONDITIONAL WEBB ELECTRODE (K130287)Rhythmlink International, LLC2013-05-30
OLYMPIC BRAINZ MONITOR (K123079)Excel-Tech Ltd. (Xltek)2013-05-08
SYNERGY FOCUS DESKTOP VERSION; SYNERGY FOCUS LAPTOP VERSION (K130346)Natus Neurology Incorporated2013-05-02
CERVELLO BIO-POTENTIAL SIGNAL ACQUISTION SYSTEM PRODUCT FAMILY (K122196)Blackrock Neuromed, LLC2013-05-02
H200 WIRELESS HAND REHABILITATION SYSTEM WITH OPTIONAL INTELLI-CONNECT EARPIECE TRIGGERING DEVICE (K123636)Bioness, Inc.2013-05-01
NEUROSTAR TMS THERAPY SYSTEM (K130233)Neuronetics2013-04-30
STERILE RADIOLUCENT SKULL PINS (K122225)Brainlab AG2013-04-26
NYSTAGRAM VIDEO NYSTAGMOGRAPHY SYSTEM (K130201)Ototronix, LLC2013-04-26
DE48-PLUS (K123915)Grass Technologies, an Astro-Med, Inc. Product Gro2013-04-24
MAYFIELD INFINITY XR2 SKULL CLAMP (K130389)Integra LifeSciences Corporation2013-04-23
SLEEP PROFILER (K130007)Advanced Brain Monitoring, Inc.2013-04-17
PAINMASTER MCT PATCH (K130114)Newmark, Inc.2013-04-16
HEARLAB ACA (K123701)Frye Electronics, Inc.2013-04-05
NEURO OMEGA SYSTEM (K123796)Alpha Omega Engineering , Ltd.2013-04-05
NEUROPRO LOW PROFILE CRANIAL PLATING SYSTEM (K122049)Kinamed, Inc.2013-04-05
WALKAIDE SYSTEM (K123972)Innovative Neurotronics, Inc.2013-04-01
D4000 DRIVE SYSTEM; D4000A DRIVE SYSTEM WITH IRRIGATION (K130497)Linvatec Corporation D/B/A Conmed Linvatec2013-03-29
STRYKER VENOM ELECTRODES AND CANNULAE (K123178)Stryker Instruments, Instruments Div.2013-03-28
BARRICADE EMBOLIZATION COIL SYSTEM (K123338)Blockade Medical2013-03-28
PROSPERA OTC TENS ELECTRONIC PULSE MASSAGER (K122744)Prospera Corporation2013-03-28
LIFELINES IEEG (K123665)Kvikna Ehf2013-03-25
MRII CRAINIAL DRILL (K122456)Mri Interventions, Inc.2013-03-22
NAVIGATED CD HORIZON SOLERA SCREWDRIVERS, TAPS, ILIAC TAPS, LEGACY TAPS (K124004)Medtronic Navigation, Inc.2013-03-22
SHUNTCHECK (K123554)Neurodx Development, LLC2013-03-07
THE ARTAS SYSTEM (K123548)Restoration Robotics, Inc.2013-02-25
ARTAS SYSTEM FROM RESTORATION ROBOTICS (K123154)Restoration Robotics, Inc.2013-02-19
MEDTRONIC STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM (K123524)Medtronic Neurosurgery2013-02-13
OSTEOFAB PATIENT SPECIFIC CRANIAL DEVICE (K121818)Oxford Performance Materials2013-02-07
EEGER4 MODEL 4.3 (K122879)Eeg Software, LLC2013-02-06
ICS IMPULSE (K122550)Gn Otometrics2013-02-01
X4 SYSTEM (K130013)Advanced Brain Monitoring, Inc.2013-01-31
VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS), AND TRUFILL DCS ORBIT DETACHABLE COIL SYSEM (K123560)Codman & Shurtleff, Inc.2013-01-25
ESWALLOW USA ELECTRODE,ESWALLOW USA LEADWIRE (K113375)Eswallow USA2013-01-25
MTS SYSTEM, WIDE-SPACE QUATTRODE PERCUTANEOUS LEADS (K123299)St. Jude Medical Neuromodulation2013-01-18
NEUROPACE BURR HOLE COVER MODEL 8110 (K123163)NeuroPace, Inc.2013-01-18
RESORB-X G (K121606)KLS-Martin L.P.2013-01-17
SCULPTOR ROBOTIC GUIDANCE ARM (RGA) (K121765)Stanmore Implants Worldwide , Ltd.2013-01-11
POWEREASE SYSTEM (K123270)Medtronic Sofamor Danek USA, Inc.2013-01-11
CRYO-TOUCH IV (K123516)Myoscience, Inc.2013-01-10
BRAINSWAY DEEP TMS SYSTEM (K122288)Brainsway , Ltd.2013-01-07
NESS L300 SYSTEM KIT, LEF MODEL LG3-5100; NESS L300 SYSTEM KIT, RIGHT MODEL LG3-5000; SMALL NESS L300 SYSTEM KIT, RIGHT (K122784)Bioness, Inc.2012-12-27
GEMORE TRUE SINE INTERFERENTIAL STIMULATOR (K122944)Gemore Technology Co, Ltd.2012-12-21
GEM-STIM COMBO STIMULATOR (K122948)Gemore Technology Co, Ltd.2012-12-21
g.HIamp (K123255)G.Tec Medical Engineering GmbH2012-12-20
PMT TRUSCAN SURFACE ELECTRODE (K122376)Pmt Corp.2012-12-19
NEURODYN RUBY MUSCLE STIMULATOR, NEURODYN AUSSIE MUSCLE STIMULATOR (K121369)Ibramed Equipamentos Medicos2012-12-19
SYNTHES NAVIGABLE PEDICLE PREPARATION INSTRUMENTS (K122211)Synthes Spine2012-12-17
NUVASIVE BENDINI SPINAL ROD BENDING SYSTEM (K122742)Nuvasive, Inc.2012-12-07
SMARTTOOLS KNEE SYSTEM (K122326)Zimmer2012-11-30
TARGET DETACHABLE COIL (K123377)Stryker Neurovascular2012-11-30
NAVIOPFS (K121936)Blue Belt Technologies, Inc.2012-11-30
SENSUS ELECTRODE (K121816)Neurometrix, Inc.2012-11-26
VECTTOR VT-200 (K121662)Alan Neuromedical Technologies, LLC2012-11-21
HEALTHMATEFOREVER (K121757)Healthmate International, LLC2012-11-20
NAVIGATION SOFTWARE HIP-UNIVERSAL; NAVIGATION SOFTWARE HIP THR-AESCULAP (K122011)Brainlab AG2012-11-15
PSG-1100 SLEEP DIAGNOSTIC SYSTEM (K120888)Nihon Kohden Corp.2012-11-09
REUSABLE CUTANEOUS ELECTRODE (K121483)Ampcare, LLC2012-10-15
BIOMET MICROFIXATION NEURO PLATING SYSTEM (K121624)Biomet Microfixation2012-10-12
TYPE 1077 ACCUSCREEN (K122067)Gn Otometrics2012-09-27
KARL STORZ NAVIGATIONPANEL UNIT (NPU) SYSTEM (K122096)KARL STORZ Endoscopy-America, Inc.2012-09-27
CUSTOM CRANIOFACIAL IMPLANT (CCI) (K121755)Kelyniam Global, Inc.2012-09-25
STERLING MEDICAL IMPULSE 3 STIMULATOR (K121305)Armstrong Industries, Inc. Dha Mediquip Int. Dha S2012-09-25
NIMBUS ELECTROSURGICAL RADIOFREQUENCY MULTITINED EXPANDABLE ELECTRODE (K121773)Biomerics2012-09-21
VIPER AND EXPEDIUM NAVIGATED INSTRUMENTS (K120867)Medos International SARL2012-09-20
SLEEP PROFILER (K120450)Advanced Brain Monitoring, Inc.2012-09-19
MEB-2300A NEUROPACK EVOKED POTENTIAL AND EMG MEASURING SYSTEM (K120397)Nihon Kohden Corp.2012-09-19
PEEK CUSTOMIZED CRAIAL IMPLANT KIT (K121153)Stryker2012-09-14
DELICOT (K121822)American Surgical Company, LLC2012-09-10
INTEGRA CAMINO ICP MONITOR (K121573)Intrgra Lifesciences Corporation2012-09-10
MINI PATCH (K121353)Well-Life Healthcare Limited2012-09-07
TENS BACK PAIN RELIEF SYSTEM (K113321)Savia Limited2012-09-04
CRAINFIX 2 TITANIUM CLAMP SYSTEM (K122353)Aesculap, Inc.2012-08-30
TRITON ELECTRIC HIGH TORQUE HANDPIECE AND SOFTWARE MODULE (K121264)Medtronic Surgical Technologies2012-08-27
OSTEOMED CRANIAL DISTRACTION SYSTEM (K121304)Osteomed2012-08-22
DYNATRON THERMOSTIM PROBE-DONE (K120835)Dynatronics Corporation2012-08-20
THE PAIN PILOT (A.K.A PAIN PILOT) (K120500)Hollywog, LLC2012-08-20
WITOUCH PRO (K120398)Hollywog, LLC2012-08-16
OSTEOSYMBIONICS PEEK CRANIAL IMPLANT (K121102)Osteosymbionics, LLC2012-08-08
BE PLUS LTM AMPLIFIER GWI AMPLIFIER (K121996)Eb Neuro S.P.A.2012-08-03
HAKIM PROGRAMMABLE AND PRECISION VALVE SHUNT SYSTEM (K122118)Codman & Shurtleff, Inc.2012-08-03
SENSUS (K121184)Neurometrix, Inc.2012-08-02
ATOM 1 (MODEL: BRC 2200) (K121578)Bioelectric Research Corporation2012-07-31
AGELESS WONDER FACIAL MUSCLE STIMULATION SYSTEM (K120511)Leto Enterprise , Ltd.2012-07-30
ELECTRONIC PULSE MASSAGER TENS ELECTRONIC PULSE MASSAGER (K113544)Prospera Corporation2012-07-27
IO-TOME DEVICE (K113073)Baxano, Inc.2012-07-27
MICROTARGETING XL STAR DRIVE SYSTEM (K121950)FHC, Inc.2012-07-26
GEMORE TENS SYSTEM (K120569)Gemore Technology Co, Ltd.2012-07-20
INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH INTRGRA CAMINO FLEX ADAPTER (K121159)Integra Lifescience Corportation2012-07-20
MERIDIAN CRANIAL PERFORATOR (K121253)Adeor Medical Technologies GmbH2012-07-17
PRESSON ELECTRODE (K121347)Rhythmlink International, LLC2012-07-12
RENAISSANCE (K120812)Mazor Robotics , Ltd.2012-07-12
ICTA (K120260)Excel-Tech Ltd. (Xltek)2012-06-29
CRYO-TOUCH III (K120415)Myoscience, Inc.2012-06-22
X4 (K120447)Advanced Brain Monitoring, Inc.2012-06-20
MICROEEG SYSTEM (K112817)Bio-Signal Group Corporation2012-06-19
DURAGEN SECURE DURAL REGNERATION MATRIX (K120600)Integra Life Sciences2012-06-15
STERILE DISPOSABLES FOR MER (K120098)Alpha Omega Engineering , Ltd.2012-06-12
STRYKER QUIKFLAP STERILE PROCEDURE PACK (K120352)Stryker2012-06-11
DISPOSABLE ADHESIVE SURFACE ELECTRODE (K120494)Spes Medica Srl2012-06-11
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