Atlas FDA

Neurology

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

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RecordFirmDate
BOSTON BAND (K111609)Boston Brace Intl., Inc.2011-08-22
LCCS INSULATED SPINAL NEEDLE (RF CANNULA) (K112231)Lccs Products Limited2011-08-19
CRANIAL REMOLDING ORTHOSIS (K111247)Orthotic Care Services, Llp2011-08-15
OSTEOMED LOW PROFILE NEURO FIXATION SYSTEM (K111176)Osteomed LP2011-08-15
BRAINLAB TRAUMA (K110204)Brainlab AG2011-08-05
MS-120BK ELECTRIC STIMULATOR (EXTENSION UNIT) (K110410)Nihon Kohden Corp.2011-08-04
KNEEHAB XP (K110350)Bio-Medical Research, Ltd.2011-08-03
CARE BACK PAIN RELIEF STIMULATOR; CARE BACK PAIN RELIEF STIMULATOR (K110707)Shenzhen Dongdixin Technology Co., Ltd.2011-08-03
ETG 255 COMBO STIMUALTOR, TEN 260 STIMUALTOR (K110390)Handelshaus Dittman GmbH2011-07-29
PE-210AK SWITCH BOX (K110376)Nihon Kohden Corp.2011-07-29
PAIN BUDDY (K102051)Biomedical Life Systems, Inc.2011-07-29
AVS ARIA NEUROMONITORING PROBE AND AVS ARIA PROBE DILATORS (K110419)Stryker Spine2011-07-28
CIRCUMAURAL ADHESIVE REPLACEMENT (K111555)R & D Medical Products, Inc.2011-07-25
ENTROPY EASYFIT SENSOR (K103129)GE Healthcare2011-07-19
STRYKER (R) PATIENT SPECIFIC POLYMER IMPLANT (K111065)Howmedica Osteonics Corp. Dba Stryker Orthopeadics2011-07-14
HORIZONTAL-VERTICAL LUMBAR VALVE AND SPETZLER LUMBAR PERITONEAL SHUNT SYSTEMS (K101381)Integra LifeSciences Corporation2011-07-07
ENTERPRISE ELECTROPHYSIOLOGY SYSTEM (K110967)Neuralynx, Inc.2011-06-30
WAVEGUARD (TM) EEG CAP (K110223)Eemagine Medical Imaging Solutions GmbH2011-06-29
MEDCAD ACCUSHAPE (TM) PEEK PATIENT SPECIFIC CRANIAL / CRANIOFACIAL IMPLANT (K110684)Vanduzen Dba Medcad2011-06-24
EPIDUCER LEAD DELIVERY SYSTEM (K110609)St Jude Medical2011-06-24
SURGIVISION INC. CLEARPOINT SYSTEM (K111073)Surgi-Vision, Inc.2011-06-22
EVERYWAY INTERFERNTIAL STIMULATOR, MODEL IF-908 (K110509)Everyway Medical Instruments Co.,Ltd2011-06-20
OWL CANNULAE (K102566)Diros Technology, Inc.2011-06-03
IPLAN (K101627)Brainlab AG2011-06-03
AVIVAFIX CONDUCTIVE GARMENT-KNEE/SHOULDER/UPPER BACK, TYPE 40 (K102614)Bio-Medical Research, Ltd.2011-06-03
DASH KNEE (K102251)Brainlab AG2011-05-17
HI-DOW-XP (K102598)Hi-Dow International, Inc.2011-05-13
DIOPSYS NOVA VEP VISION TESTING SYSTEM (K101763)Diopsys, Inc.2011-05-09
CODMAN BACTISEAL ENDOSCOPIC VENTICULAR CATHETER (K110751)Codman & Shurtleff, Inc.2011-05-09
TITAN (K103760)Interacoustics A/S2011-05-05
OWL RF PROBES (K110593)Diros Technology, Inc.2011-05-05
L300 PLUS SYSTEM (RIGHT, LEFT), L300 PLUS SYSTEM UPGRADE KIT (RIGHT, LEFT) (K103343)Bioness, Inc.2011-04-29
MICROPLEX COIL SYSTEM- COSMOS 10, HYDROCOIL SYSTEM- HYDROFRAME 10 (K103758)MicroVention, Inc.2011-04-28
RENAISSANCE SYSTEM (K110911)Mazor Robotics , Ltd.2011-04-28
NATUS SLEEPWORKS, MODEL 104017 (K090277)Excel-Tech Ltd. (Xltek)2011-04-19
AOI CRANIAL HELMET (K103362)Advanced Orthopro, Inc.2011-04-18
KELYNIAM CUSTOM SKULL IMPLANT (CSI) (K103582)Kelyniam Global, Inc.2011-04-14
SMITH & NEPHEW, INC. SURESHOT DISTAL TARGETING SYSTEM V2.1 (K110240)Smith & Nephew, Inc.2011-04-14
NICOLET WIRELESS EEG (K103140)Carefusion 209, Inc.2011-04-08
RT200 (K103370)Restorative Therapies, Inc.2011-04-05
KNEEALIGN SYSTEM (K103829)Orthalign, Inc.2011-04-04
RT600 (K103366)Restorative Therapies, Inc.2011-04-04
BRAINLAB KNEE (K102990)Brainlab AG2011-04-04
THE ARTAS SYSTEM FROM RESTORATION ROBOTICS (K103428)Restoration Robotics, Inc.2011-04-04
MANDOMETER III (DEN070014)Ab Mando2011-03-31
ZMACHINE, MODEL DT-100 (K101830)Consolidated Research of Richmond, Inc.2011-03-31
ODFS PACE (K102115)Odstock Medical, Ltd.2011-03-30
NAVITRACK SYSTEM - OS KNEE UNIVERSAL, CAS SAME INCISION TIBIA REFERENCE (K110054)Zimmer Cas2011-03-24
ELIBRA UNI SOFT-TISSUE FORCE SENSOR, MODEL 61-XXXX(5 MODELS, DIFFERENT SIZES (K093046)Synvasive Technology, Inc.2011-03-22
HEAD FIATION DEVICE (HFD 100) (K103493)Imris, Inc.2011-03-11
FLUOROMAP SOFTWARE, 9 FLUORODISC (BELT), 12 FLUORO DISC (BELT), CLOSE TUBE CLIP (K103400)Stryker Corporation2011-03-07
RAUMEDIC- ICP-MONITORING SYSTEM (K103206)Raumedic AG2011-03-04
HOLTER IN-LINE SHUNT FILTER, HOLTER CEREBRAL CATHETER RESERVOIR, ACCU-FLO CONNECTORS; ACCU-FLO THREE WAY CONNECTOR; CODM (K102961)Codman & Shurtleff, Inc.2011-02-18
GDC 360 DETEACHABLE COIL (K103355)Boston Scientific Corp2011-02-16
NEUROPORT CORTICAL MICROELECTRODE ARRAY SYSTEM (K110010)Blackrock Microsystems, Inc.2011-02-09
EXPLORER LIVER (PASSIVE TRACKING) (K101979)Pathfinder Therapeutics, Inc.2011-02-09
NAVIGATION MARKER, REFLECTIVE MARKER SPHERES (K103192)Ilumark GmbH2011-02-07
SURGIVISION MR COMPATIBLE VENTRICULAR CANNULA (K102101)Surgivision, Inc.2011-01-26
PENUMBRA EMBOLIZATION COIL SYSTEM (K103305)Penumbra, Inc.2011-01-26
CODMAN BACTISEAL CATHETERS, CODMAN BACTISEAL EVD CATHETER (K102589)Codman & Shurtleff, Inc.2011-01-14
MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM (K102077)Cma Microdialysis AB2011-01-14
GEOSOURCE (K092844)Electrical Geodesics, Inc.2010-12-21
CAMINO 110-4B OLM INTRACRANIAL PRESSURE MNITORING KIT; CAMINO 110-4G POST CRANIOTOMY SUBDURAL PRESSURE MONITORING KIT; C (K102875)Integra LifeSciences Corporation2010-12-20
FRONTIER DEVICES NEURO SYSTEM (K100205)Folsom Metal Products, Inc.2010-12-13
INZONE DETACHMENT SYSTEM (K103008)Boston Scientific Corp2010-12-10
ELECTRO INTERSTITIAL SCAN (K102166)Ld Technology, LLC2010-12-10
HIP SEXTANT INSTRUMENT SYSTEM (K093491)Surgical Planning Associates2010-12-09
NEMA-ST, MODEL V1.0.2 (K100668)Nervomatrix, Ltd.2010-12-08
MEDPOR FIXATION SYSTEM-CRANIAL, MODELS 80080, 80079 (K101835)Porex Surgical, Inc.2010-12-03
STELLATE GRIDVIEW (K100126)Excel-Tech Ltd. (Xltek)2010-12-03
ADHESIVE ELECTRODES (K102842)Reno Medical Limited2010-12-02
MAX-IF1000 (K100246)Bio Protech, Inc.2010-11-24
INTEGRA ELECTRODE TUNNELING NEEDLE (K102802)Integra LifeSciences Corporation2010-11-23
SENSOMETRICS SOFTWARE (K101133)Dpcom AS2010-11-18
SCALP DURA RETRACTOR, MODEL KS00474 (K093054)KARL STORZ Endoscopy-America, Inc.2010-11-15
AESCULAP- MEITHKE PROGAV PROGRAMMABLE SHUNT SYSTEM (K103003)Aesculap, Inc.2010-11-09
SMITH & NEPHEW, INC. SURESHOT DISTAL TARGETING SYSTEM V2.0.2 (K102967)Smith & Newphew, Inc.2010-11-04
NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701 (K092477)Neurowave Systems, Inc.2010-10-29
MULTI-LEAD TRIALING CABLE MODEL 355531 (K102523)Medtronic, Inc.2010-10-26
ELEKTA NEUROMAG WITH MAXFILTER (K091393)Elekta Neuromag OY2010-10-26
CRANIAL LOOP CRANIAL BONE FIXATION SYSTEM (K101235)Neos Surgery S.L2010-10-25
EXACTECH GPS (K100742)Blue Ortho2010-10-21
TARGET DETACHABLE COIL (K102672)Boston Scientific Corp2010-10-15
ROSA SURGICAL DEVICE (K101791)Medtech S.A.S2010-09-23
NORIAN REINFORCED, NORIAN REINFORCED FAST SET PUTTY (K102018)Synthes USA Products, LLC2010-09-23
CRYO-TOUCH II (K102021)Myoscience, Inc.2010-09-17
SUPERIOR STARBURST REUSABLE SELF-ADHERING TENS/NMES/FES STIMULATING ELECTRODE (K100418)Covidien2010-09-03
TENS STIMULATOR, MODELS 2800 AND 3000 (K102014)Koalaty Products, Inc.2010-08-31
TENZING SYSTEM (K102130)Mazor Surgical Technologies , Ltd.2010-08-26
LEGEND POWER ADAPTER MODEL: 6475000 (K101168)Medtronic Sofamor Danek2010-08-24
DISPOSABLE NERVE STIMULATING PROBE, BIPOLAR CONCENTRIC, DISPOSABLE NERVE STIMULATOR PROBE, BIPOLAR SIDE BY SIDE (K100912)Kirwan Surgical Products, Inc.2010-08-19
AESCULAP PEEK CRANIOFIX (K091692)Aesculap, Inc.2010-08-12
PROTEKTOR 32 (K093304)Natus Medical, Inc.2010-08-11
LIFELINES PHOTIC STIMULATOR (K101691)Lifelines , Ltd.2010-08-10
DUOCOOL PAIN MANAGEMENT PROBE, MODEL OSP-17-180-20 (K101372)Baylis Medical Co., Inc.2010-08-10
SALUTUNNEL NERVE PROTECTOR, MODEL ED-20329, ED-20330, ED-20331 (K100382)Salumedica, LLC2010-08-05
ORTHOMAP 3D 1.1 MODULE (K093206)Stryker Corp.2010-08-04
VIGILANT EEG MONITOR MODEL VIGILANT 2.0 (K101386)Infinite Biomedical Technologies, LLC2010-07-30
MODIFICATION TO: MICROBLADE SHAVER AND ACCESSORIES (K100958)Baxano, Inc.2010-07-23
XINIWAVE, MODEL XW-18 (K100441)International Trade Group, Inc.2010-07-15
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