Atlas FDA

Neurology

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

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RecordFirmDate
MAKOPLASTY TOTAL HIP APPLICATION, RIO STANDARD SYSTEM (K121064)Mako Surgical Corporation2012-06-06
ADHERENT VISUAL STIMULATOR GOGGLES (K113785)Anschel Technology, Inc.2012-06-06
BRAIN PORT (K120691)Nico Corporation2012-06-05
ULTIMA NEO (K120054)Pain Management Technologies2012-06-05
AESCULAP-MEITHKE PROSA ADJUSTABLE SHUNT SYSTEM (K120559)Aesculap, Inc.2012-05-24
MAYFIELD SKULL CLAMP (K120633)Integra LifeSciences Corporation2012-05-24
PRAEZIS PLUS (K110644)Tatramed Spol. S.R.O.2012-05-24
NEXSTIM NAVIGATED BRAIN STIMULATION (NBS) SYSTEM 4, NEXSTIM NBS SYSTEM 4 WITH NEXSPEECH(TM) (K112881)Nexstim OY2012-05-22
VISIONSEARCH 1 (K120104)Visionsearch Pty, Ltd.2012-05-21
LONG LIFE PADTM (K120516)Omron Healthcare, Inc.2012-05-17
JIAJIAN TENS (K112288)Wuxi Jiajian Medical Instrument Co., Ltd.2012-05-02
HUMMINGBIRD SUBDURAL H900DS (DRAINAGE AND ICP), HUMMINGBIRD SUBDURAL- H800S (ICP ONLY) (K113088)Innerspace, Inc.2012-05-02
HYDROCOIL EMBOLIC SYSTEM (HES) (K120908)MicroVention, Inc.2012-04-25
CAREFUSION NICOLET EDX (K120979)Carefusion 209, Inc.2012-04-25
BRAIN BIOPSY NEEDLE (K112094)Ad-Tech Medical Instrument Corp2012-04-24
NESS L300 SYSTEM KIT, LEFT, NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT, (K120853)Bioness, Inc.2012-04-20
RAPID PROGRAMMER (K113611)St Jude Medical2012-04-20
TARGET DETACHABLE COIL (K120850)Stryker Neurovascular2012-04-17
NEURO CHECK DEVICE WITH IO-FLEX WIRE (K113533)Baxano, Inc.2012-04-11
RAUMEDIC-ICP-TEMP-MONITORING-SYSTEM (K120252)Raumedic AG2012-04-11
ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM (K120686)Codman & Shurtleff, Inc.2012-04-04
PENUMBRA COIL SYSTEM/PENUMBRA COIL 400 (K120330)Penumbra, Inc.2012-04-02
ULTRA BEAUTY (K112351)Johari Digital Healthcare , Ltd.2012-03-30
SURGICASE GUIDE (K111558)Materialise NV2012-03-27
IMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD) (K113748)Imris, Inc.2012-03-23
GENERAL PRUPOSE LOCALIZERS AND ADAPTERS-NEW ACCESSORIES FOR SONOWAND SYSTEM (K112469)Sonowand AS2012-03-23
NIHON KOHDEN EEG-1200A WITH JE-120A MULTI CHANNEL ELECTRODE JUNCTION BOX (K113117)Nihon Kohden America, Inc.2012-03-22
HIVOX BIOTEK INC. (K112392)Hivox Biotek, Inc.2012-03-19
NIHON KOHDEN QP-160 AK TREND PROGRAM WITH THE ADDITION OF DSA ASYMMETRY TREND AND FFT P (K120485)Nihon Kohden America, Inc.2012-03-16
CAREFUSION NICOLET EDX (K112052)Carefusion 209, Inc.2012-03-15
HBIDB - HUMAN BRIAN INDEX SOFTWARE (K112077)Corscience GmbH & Co. KG2012-03-09
QUADRASPHERE 30 TO 60 (K113822)Biosphere Medical, Inc.2012-03-08
COVAORTHO-NERVE RESORBABLE COLLAGEN MEMBRANE (K103081)Biom'Up Sas2012-03-02
DELTAMAXX 18 MICROCOIL SYSTEM (K120274)Codman and Shurtleff, Inc.2012-03-02
RESTORIS PARTIAL KNEE APPLICATION (PKA), RIO STANDARD SYSTEM (K112507)Mako Surgical Corporation2012-03-01
FD TENS 2070 (K111654)Fuji Dynamics , Ltd.2012-03-01
PAIN-AID (K113037)Pdi Works, LLC2012-03-01
FIXATE TISSUE BAND (K113805)Anulex Technologies, Inc.2012-02-23
LEFORTE NEURO SYSTEM BONE PLATE (K112812)Jeil Medical Corporation2012-02-22
GEODESIC EEG MOBILE 100 (GEM 100) (K112353)Electrical Geodesics, Inc.2012-02-17
CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM (K113526)Medos International SARL2012-02-16
ELECTROPULSE-COSMETIC (K113724)Pain Relief Technologies2012-02-15
ELECTRO-CAP SYSTEM (K112319)Electro-Cap Intl., Inc.2012-01-27
SPOTLIGHT ACCESS SYSTEM (K113273)Johnson & Johnson2012-01-27
THERATRODE (K112312)Phoenix Medical Devices, Llp2012-01-25
NEUROTECH RECOVERY (K112934)Bio-Medical Research, Ltd.2012-01-20
NEUROTECH PLUS (K112258)Bio-Medical Research, Ltd.2012-01-09
SYNTHECEL DURA REPLACEMENT DEVICES (K113071)Synthes2012-01-09
STRYKER UNIVERSAL NEURO 3 SYSTEM (K112557)Stryker2012-01-05
ELECTRO-GEL (K111717)Electro-Cap Intl., Inc.2012-01-05
GALAXY SYSTEM; JUPITER (K111055)Personal Health Institute International2011-12-21
FIXATE TISSUE BAND (K113400)Anulex Technologies, Inc.2011-12-16
SPOTLIGHT ACCESS SYSTEM (K112913)Johnson & Johnson2011-12-16
SBV2, MULTICHARGER MODEL MC10V2 (K111514)Sleep Performance D.B.A. Fatigue Science2011-12-16
ANSPACH DISSECTION TOOLS (K113476)The Anspach Effort, Inc.2011-12-16
HYDROCOIL EMBOLIC SYSTEM (HES) (K113457)MicroVention, Inc.2011-12-16
TARGET DETACHABLE COIL (K113412)Stryker Neurovascular2011-12-13
THE BUZZ FACIAL TONING SYSTEM (K102494)Daka International , Ltd.2011-12-09
MODEL PM3030 (K110068)Omron Healthcare, Inc.2011-12-08
PRESSON ELECTRODE (K103103)Persyst Development Corp.2011-12-08
H-WAVE (K112485)Electronic Waveform Lab, Inc.2011-12-06
BENDINI(TM) SPINAL ROD BENDING SYSTEM (K111811)Nuvasive, Inc.2011-12-05
HYDROCOIL(R) EMBOLIC SYSTEM (HES) (K112181)MicroVention, Inc.2011-12-01
RENAISSANCE SYSTEM (K113228)Mazor Robotics , Ltd.2011-12-01
MEDTRONIC ARES ANTIBIOTIC-IMPREGNATED CATHETER (K110560)Medtronic Neurosurgery2011-11-18
OCTRODEX(TM), QUATTRODEX(TM), INTRODEX(TM), EPIDURAL NEEDLE, STYLETS (K112214)St. Jude Medical Neuromodulation2011-11-17
ACUFEX DIRECTOR APPLICATION ANATOMIC GUIDE SYSTEM (K111843)Smith & Nephew Inc., Endoscopy Div.2011-11-14
BMR FACE (K103031)Bio-Medical Research, Ltd.2011-11-10
X-FORCE (K111557)Seven Seas Distribtion and Manufacturing, LLC2011-11-10
FD TENS 2050 OR SLIDE TENS MODEL FD2050 (K111645)Fuji Dynamics , Ltd.2011-11-09
NUFACE PLUS (K103472)Carol Cole Company2011-11-07
BWIII EEG, BWIII EEG PLUS, BWIII PSG, BWIII PSG PLUS (K112107)Neurovirtual USA, Inc.2011-10-28
FIXATE TISSUE BAND (K112849)Anulex Technologies, Inc.2011-10-27
REHASTIM 2, REHAMOVE 2 (K112844)Hasomed GmbH2011-10-27
AESCULAP- MEITHKE SHUNT SYSTEM (K110206)Aesculap, Inc.2011-10-27
IPC POWEREASE SYSTEM (K111520)Medtronic Xomed, Inc.2011-10-26
LIFECARE ARM & LEG PAIN RELIEF SYSTEM (K112415)Everyway Medical Instruments Co.,Ltd2011-10-21
NEUROLAC(R) NERVE GUIDE (K112267)Polyganics B.V.,2011-10-20
QUADRA BLOC TENS PLUS (K102278)Gradient Technologies, LLC2011-10-20
DASH HIP (K110021)Brainlab AG2011-10-18
EVERYWAY LOW BACK PAIN RELIEF SYSTEM (K110716)Everyway Medical Instruments Co.,Ltd2011-10-18
CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM, CODMAN CERTAS THERAPY MANAGEMENT SYSTEM (K112156)Medos International SARL2011-10-17
DISPOSABLE ELECTRODE (K111737)Sanibel Supply2011-10-14
RAUMEDIC ICP MONITORING SYSTEM (K112017)Raumedic AG2011-10-11
ERASE HAND- HELD CONTROLLER; ERASE SINGLE USE ELECTRIC CATRIDGE SYSTEM (K101592)Cheng Medical, Corporation2011-10-06
C2 NERVEMONITOR SYSTEM WITH ACCESSORIES (K111647)Inomed Medizintechnik GmbH2011-10-06
NEUROVISION NERVE LOCATOR MONITOR (K110140)Neurovision Medical Products, Inc.2011-09-30
EMG SYSTEM (K111687)Myotronics-Noromed, Inc.2011-09-29
X12 STERILE REFLECTIVE MARKER SPHERE (K111443)Pinsco Inc. Dba B & L Engineering2011-09-29
HYDROCOIL EMBOLIC SYSTEM (HES) (K112226)MicroVention, Inc.2011-09-29
NT 2000 LESIONING GENERATOR (K111576)Neuro Therm, Inc.2011-09-20
MICROPLEX COIL SYSTEM-VECTOR MODEL 030606XXX-V, 030610XXX-V, 30615XXX-V, 061020XXX-V, 061030XXX-V, 101530XXX-V, 101540XX (K111451)MicroVention, Inc.2011-09-20
TRAGET DETACHABLE COIL (K112385)Stryker Neurovascular2011-09-15
NESS H200 WIRELESS HAND REHABILITATION SYSTEM USER KIT AND CLINICAN KIT (K111767)Ness-Neuromuscular Electrical Stimulation Systems2011-09-15
REUSABLE STIMULATING ELECTRODES (K111270)Bio Protech, Inc.2011-09-13
FIXATE TISSUE BAND (K111462)Anulex Technologies, Inc.2011-09-08
FRIENDSHIP MEDICAL DISPOSABLE PRE-GELLED AG / AGCL SURFACE ELECTRODE (K110289)Xian Friendship Medical Electronics Co., Ltd.2011-08-30
ZYTO HAND CRADLE (K111308)Zyto Technologies, Inc.2011-08-30
HARMONIE SYSTEM (K083577)Stellate Systems2011-08-29
LIFECARE CONDUCTIVE GARMENTS (K103719)Everyway Medical Instruments Co.,Ltd2011-08-24
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