Atlas FDA

Neurology

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

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RecordFirmDate
INTERACOUSTICS EP 15 ABR STAND ALONE UNIT (K991853)Idem (Int'L Dist. of Electronics For Medicine)1999-10-25
VENTIL-A ORAL PROTECTOR (K992269)Somatics, Inc.1999-10-25
ASPIRATION/IRRIGATION CATHETER, MODEL AC-1000 (K992796)Image-Guided Neurologics, Inc.1999-10-25
ACCUGUIDE MUSCLE INJECTION MONITOR (K990793)Medtronic Xomed1999-10-22
THE BRIGHT MEDICAL DILATION RETRACTOR SYSTEM (K992898)Bright Medical Instruments1999-10-21
CODMAN SINGLE AND DOUBLE LUMEN SKULL BOLT KITS (K992591)Codman & Shurtleff, Inc.1999-10-15
ACTITRAC (K992410)Individual Monitoring Systems, Inc.1999-10-15
NEUROFAX, MODEL EEG-1100A (K992742)Nihon Kohden America, Inc.1999-10-14
VIEWPOINT ENT/ORTHOPEDIC OPTION (K991256)Philips Medical Systems (Cleveland), Inc.1999-10-08
LEKSELL IMAGE GUIDANCE SURGICAL SYSTEM, VIEW SCOPE, SURGISCOPE,ELEKTA INSIGHT (K992882)Elekta Instrument AB1999-09-24
RENEW RECEIVER (K992946)Advanced Neuromodulation Systems1999-09-24
NMT NEUROSCIENCES CONTROL UNIT, MODEL 910-600 & NMT NEUROSCIENCES DISPOSABLE DRAINAGE LINE KIT, MODEL 910-6XX (K990660)Nmt Neurosciences Implants S.A.1999-09-23
BONESOURCE HYDROXYAPATITE CEMENT (HAC) EXPANDED KIT (K991398)Stryker Leibinger1999-09-22
MINI-LOGGER SERIES 2000 (K991045)Mini-Mitter Co., Inc.1999-09-21
RADIONICS MICROELECTRODE KIT (K991399)Radionics, Inc.1999-09-21
PHAZX VLD-100 (K992129)Phazx Systems, Inc.1999-09-17
@ TARGET (K983410)Brainlab AG1999-09-17
TENS/FES/NMES ELECTRODES (K983097)Uni-Patch, Inc.1999-09-17
BIO-LOGIC EVOKED POTENTIAL FOR ABAER I (K992807)Bio-Logic Systems Corp.1999-09-14
CORTICAL MAPPING UNIT, MODEL CMU (K992194)Ad-Tech Medical Instrument Corp1999-09-13
COSMAN ROBERT WELLS FUNCTIONAL PROBE MICRODRIVE (K992721)Radionics, Inc.1999-09-10
RADIONICS XDC EXTERNAL VENTRICULAR CATHETER (K992379)Radionics, Inc.1999-09-08
NIHON KOHDEN MEB-2200A NEUROPACK EVOKED POTENTIAL & EMG MEASURING SYSTEM WITH ACCESSORIES (K991899)Nihon Kohden America, Inc.1999-09-01
ARTISAN ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY (K992283)Airsep Corp.1999-08-27
NAVIGUS TRAJECTORY GUIDE, MODEL TG-XXXX (K992304)Image-Guided Neurologics, Inc.1999-08-27
MITAKA POINT SETTER (K991989)Mitaka USA, Inc.1999-08-27
SNN SYSTEM WITH OLIVIER DOUBLE CHUCK SUPPORT ARM OPTION (K992457)Surgical Navigation Specialists, Inc.1999-08-27
ELECTRO-NERVE STIMULATOR TENS, MODEL LX (K990230)Biomedical Life Systems, Inc.1999-08-19
XL TEK EVOKED POTENTIAL HEADBOX, MODEL EP-16 (K992313)Excel Tech. , Ltd.1999-08-19
CUTANEOUS (BAR) ELECTRODE (K991769)Neuro Supplies, Inc.1999-08-18
DIGITAL RING ELECTRDE (K991771)Neuro Supplies, Inc.1999-08-18
CUTANEOUS (GROUND) ELECTRODE (K991770)Neuro Supplies, Inc.1999-08-18
CUTANEOUS (DISC) ELECTRODE (K991772)Neuro Supplies, Inc.1999-08-18
PARALLAX TRACER RADIOPAQUE PARTICLES (K991893)Parallax Medical, Inc.1999-08-13
NORODYN 8000 SEMG SYSTEM, ND-8000 (K992439)Myotronics-Noromed, Inc.1999-08-13
EXPRESSEYE (K992473)Optomotor Laboratories1999-08-12
REMOTE INTRODUCER, MODEL PI-1000 (K990907)Image-Guided Neurologics, Inc.1999-08-12
H20- TETHERED OPTION (K992291)Grass-Telefactor Product Group1999-08-06
EXCEL PHOTIC STIMULATOR, MODEL (XLPS-1) (K991903)Excel Tech. , Ltd.1999-08-04
EYE TRAK TM, COMPUTERIZED ELECTRONYSTAGMOGRAPH (ENG), MODEL ETV-XXXX (K991642)Bertec Corp.1999-08-03
KOMET XK-95 PERFORATOR MOTOR (MI-102) (K991625)Komet Medical1999-07-30
ICS MEDICAL CHARTR ENG/VNG DIAGNOSTIC SYSTEM (K991497)Ics Medical Corp.1999-07-28
BIOSACA SYSTEM, MODEL 800 (K991446)Biosys AB (Publ)1999-07-23
ELEKTA STEREOTACTIC GUIDE (K991636)Elekta Instrument AB1999-07-20
SYNTHES CRANIAL FLAP TUBE CLAMP (K992000)Synthes (Usa)1999-07-20
SYNTHES CRANIAL FLAP TWIST CLAMP (K991860)Synthes (Usa)1999-07-20
NEUROTREND MULTIPARAMETER SENSOR, C7004S, TO OPERATE WITH PARATREND 7+ MULTIPARAMETER SENSOR, MPM7001S, AND SATELLITE MS (K980380)Diametrics Medical, Ltd.1999-07-14
SPINE APPLICATIONS FOR THE MAYFIELD/ACCISS OPERATING ARM AND OPTICAL ACCISS SYSTEMS MODULE, MAYFIELD/ACCISS SPINE RING A (K991267)Ohio Medical Instrument Co., Inc.1999-07-12
XLTEK POLYSOMNOGRAPHY HEADBOX, MODEL # PSG-40 (K991900)Excel Tech. , Ltd.1999-07-12
CODMAN MICROSENSOR VENTRICULAR CATHETER KIT (K991222)Johnson & Johnson Professionals, Inc.1999-07-09
VIEWPOINT TOOLS- STERRAD (K983764)Philips Medical Systems (Cleveland), Inc.1999-07-08
DURAGEN DURAL GRAFT MATRIX (K982180)Integra Lifesciences Corp.1999-07-06
FRAMELESS NEUROMATE (K991081)Integrated Surgical Systems, Inc.1999-06-25
RENEW LEAD EXTENSION (K991784)Advanced Neuromodulation Systems1999-06-24
SIEMENS INFINITY EEG POD (K991012)Siemens Medical Solutions USA, Inc.1999-06-24
ACTIWATCH-SCORE (K991033)Mini-Mitter Co., Inc.1999-06-23
Z KAT FLUROTACTIC GUIDANCE SYSTEM MKI (K984298)Z-Kat, Inc.1999-06-23
BIOPOTENTIAL SKIN ELECTRODE, MODELS BME 300, BME 200, BME 100, BME 150 (K991199)Biomed Products1999-06-22
DERMASTIM PLUS, PIGTAILS, FLEXSTIM SUPERFLEX, FLEXSTIM PLUS, CARBONSTIM VERTASTIM, ENDURO (K982096)Rapid Mfg. Co.1999-06-18
MICROELECTROENCEPHALOGRAPHY PROFESSIONAL SYSTEM 5000 (EEG PRO SYSTEM 5000) (K991077)Microrecording Systems Consultants, LLC1999-06-09
MEDIPOINT (K982961)Medipoint , Ltd.1999-06-07
SUGITA TITANIUM ANEURYSM CLIP (K990202)Mizuho America, Inc.1999-06-04
INSIGHT MILLENNIUM (K990778)Fasstech1999-06-03
KSEA NEURO-FIBERSCOPE (K991069)KARL STORZ Endoscopy-America, Inc.1999-06-03
XK-95 HIGH SPEED MOTOR DRILL SYSTEM (K984035)Komet Medical1999-06-03
LAMITRODE LEADS (K990469)Advanced Neuromodulation Systems1999-06-03
BEVERLY REFERENTIAL VALVE (NL850-9710) WITH INTEGRAL PERITONEAL CATHETER (NL850-9720) VALVE KIT (NL850-9730) (K981246)Integra Neurocare, LLC1999-05-26
VECTORVISION2 (K983831)Brainlab AG1999-05-19
BRAINMASTER 2E MODULE AND SOFTWARE BIOFEEDBACK DEVICE (K990538)Brainmaster1999-05-19
DIAMOND II VALVE (K991429)Phoenix Biomedical Corp.1999-05-19
WARATAH DIGITAL EEG AND SLEEP ACQUISITION DEVICES WITH, OR WITHOUT, PULSE OXIMETRY,CARDINAL DIGITAL EEG AND SLEEP ACQUIS (K990522)Lamont Medical, Inc.1999-05-19
THE BAGNOLI-8 EMG SYSTEM (K990356)Delsys, Inc.1999-04-29
OPTICAL TRACKING SYSTEM (OTS) (K990632)Radionics, Inc.1999-04-29
MEDTRONIC PS MEDICAL INTRODUCER SHEATH 12F,14F,15F, MODELS 3805-012, 3805-014, 3805-015 (K990333)Medtronic PS Medical1999-04-28
RAPIDFLAP CRANIAL CLAMP (K991029)Walter Lorenz Surgical, Inc.1999-04-23
FLUORONAV MODULE FOR THE STEALTHSTATION SYSTEM (K990214)Surgical Navigation Technologies, Inc.1999-04-22
EEG ELECTRODES MODEL 445 SERIES (K982053)Class A Ent.1999-04-20
RADIONICS EQUI-FLOW VALVE, VENTRICULAR AND PERITONEAL CATHETER WITH EZ-COAT (K980903)Radionics, Inc.1999-04-19
MSB (ELECTRICAL STIMULATION) ELECTRODES (DISPOSABLE). (TENS/FES/NMES) (K990370)Msb,Uk1999-04-12
TL250 INTERFERENTIAL/MUSCLE STIMULATOR INTERFERENTIAL CURRENT THERAPY MUSCLE STIMULATOR (K990129)Therapy Link, Inc.1999-04-12
CRX WORLD SHUNT (K990256)Phoenix Biomedical Corp.1999-04-01
VIEWPOINT MICROSCOPE OPTION (K990860)Philips Medical Systems (Cleveland), Inc.1999-03-30
VIEWPOINT PASSIVE TOOL OPTION (K990868)Philips Medical Systems (Cleveland), Inc.1999-03-30
VASCULAR OCCLUSION SYSTEM (K983483)Cordis Neurovascular, Inc.1999-03-24
OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM (K983229)Olympic Medical Corp.1999-03-23
ACTIWATCH (K983533)Mini-Mitter Co., Inc.1999-03-23
NEUROTUBE (K983007)Neuroregen, LLC1999-03-22
THE BIOPLATE SHUNT CONNECTOR (K984583)Biomedics1999-03-15
PRECLUDE ACUSEAL DURA SUBSTITUTE (K984534)W. L. Gore & Associates, Inc.1999-03-15
BIONICARE STIMILATOR SYSTEM, MODEL BIO-1000 (K983228)Murray Electronics1999-03-15
BIOSACA SYSTEM (K984580)Biosys AB (Publ)1999-03-12
BUZBEE (K982173)Mwr Electronics Industrial Co.1999-03-11
OPTICAL TRACKING SYSTEM MICROSCOPE MODULE II, MODEL OTS MMII (K990326)Radionics Software Applications, Inc.1999-03-04
RELIEFBAND MST DEVICE, MODELS RB-2, RB-6, RB-R (K982967)Woodside Biomedical, Inc.1999-02-23
FRIDDLE HALO SYSTEM, FRIDDLE MRI HALO SYSTEM (K980689)Friddle'S Orthopedic Appliances, Inc.1999-02-18
AESCULAP AXIAL CLIP APPLIER (K984109)Aesculap, Inc.1999-02-12
TRAJECTORY GUIDE, MODEL # TGX-XXX (K983539)Image-Guided Neurologics, Inc.1999-02-12
CARE TENS (K984025)Care Rehab, Inc.1999-02-10
MEDTRONIC MODEL 7495 EXTENSION KIT (K990104)Medtronic Vascular1999-02-09
BECKER EXTERNAL DRAINAGE AND MONITORING SYSTEM (K984053)Medtronic PS Medical1999-02-04
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