meddevicedb.com FDA Device Reference

Review Panel

Neurology FDA 510(k) Clearances & Devices

Cleared Devices
6,130
Product Codes (page)
34
Latest Decision
1986-09-09

Clearances · page 55 of 62

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K862718 VERSA STIM Conmedcorp GXY Class II 1986-09-09
K861896 UNI-TENS XL TENS Solcoor, Inc. GZJ Class II 1986-09-09
K861894 AGAR 9K TENS Solcoor, Inc. GZJ Class II 1986-09-09
K862231 EMPI, MODEL 1000 HAND HELD ELECTRODE Empi GXY Class II 1986-08-27
K860289 PHD-36 PHYSIOLOGICAL SIGNAL AMPLIFIER Professional Health Technologies, Inc. GWL Class II 1986-08-25
K862971 MICRA MICROSURGICAL INSTRUMENTS Cordis Corp. GZX Class I 1986-08-25
K861900 LIFESCAN EVOKED POTENTIAL SYSTEM Neurometrics GWF Class II 1986-08-25
K861031 WYLER SPHENOIDAL ELECTRODE Ad-Tech Medical Instrument Corp GZL Class II 1986-08-25
K862989 SURGICAL DRILL (ELECTRIC) INCLUDING HANDPIECE Entronics HBC Class II 1986-08-21
K854663 NEUROFAX 7310 SERIES (EEG) Nihon Kohden America, Inc. GWQ Class II 1986-08-20
K861014 AMPLAID MK15 (EVOKED POTENTIAL SYSTEM) Amplaid USA, Inc. GWL Class II 1986-08-20
K854662 OEE_7102 EEG/TREND MONITOR Nihon Kohden America, Inc. GWS Class I 1986-08-20
K862355 TRANS-PULSE MODEL #1103 The Sun Co. GZJ Class II 1986-08-19
K860968 TM-3400, NOMAD (MODIFIED) Tracor Northern, Inc. GWF Class II 1986-08-18
K862337 ULTRAPAC II SD (TM) Medical Devices, Inc. GZJ Class II 1986-08-18
K861119 WALLANT NEUROLOGIX DUAL PUR NERVE/NEUROMUSCU STIMU Wallant Intl. Trade, Inc. GZJ Class II 1986-08-14
K861629 KOMAI CT-STEREOTACTIC APPARATUS AND ACCESSORIES Downs Surgical , Ltd. HAW Class II 1986-08-12
K860458 ELECTROPHYSIOLOGICAL SYSTEM TO MONITOR SKIN TEMP. Oxford Medilog, Inc. OLV Class II 1986-08-12
K861961 CAMINO CSF DRAINAGE SYSTEM MODEL 040 Camino Laboratories, Inc. JXG Class II 1986-08-12
K862303 BECKER EXTERNAL DRAINAGE/MONITOR SYS LUMBAR CATH. Pudenz-Schulte Medical Research Corp. JXG Class II 1986-08-12
K860378 MIND MAP (20 CHANNEL EEG) Mind Systems Corp. OLT Class II 1986-08-12
K860456 MODEL 9000 RECORDING & ELECTROPHYSIOLOGICAL SYSTEM Oxford Medilog, Inc. GWQ Class II 1986-08-11
K860847 WALLANT NEUROLOGIX GENERAL PURPOSE TENS Wallant Intl. Trade, Inc. GZJ Class II 1986-08-07
K862513 EXTERNAL VENTRICULAR & LUMBAR DRAINAGE SETS Cordis Corp. JXG Class II 1986-08-01
K862028 ULTRAHESIVE II POSTOP ELECTRODE Medical Devices, Inc. GXY Class II 1986-08-01
K862494 POLYESTER SPONGE PATTIE American Silk Sutures, Inc. HBA Class II 1986-07-30
K852061 PULSAR NEUROSTIMULATOR Andromeda Research, Inc. GZJ Class II 1986-07-18
K862160 CAMINO HAND DRILL - MODEL 030 Camino Laboratories, Inc. HBG Class II 1986-07-18
K861830 EMPI MODEL GLS 450, TENS Empi GZJ Class II 1986-07-15
K861822 MALIS SURGICAL MESH FOR SKULL /SPINAL COLUMN REPAI Valley Forge Scientific Corp. GWO Class II 1986-07-11
K855232 SOMATOSENSORY EVOKED POTENTIAL STIMULATOR Neuroscience, Inc. GWF Class II 1986-07-03
K862011 MULTI-DAY ELECTRODES Medical Electronic Assn. GXY Class II 1986-07-03
K861451 EMPI MODEL 720 NMS, TENS Empi GZJ Class II 1986-07-03
K860210 ELEFIX ELECTRODE CREAM Nihon Kohden America, Inc. GYB Class II 1986-07-01
K862331 FUJITSU MALLEABLE - TIP BRAIN SPATULA Downs Surgical , Ltd. HAO Class I 1986-07-01
K861956 JELTRODE Henley Intl. GXY Class II 1986-06-26
K854030 WRIST ACTIGRAPH Ambulatory Monitoring, Inc. GWQ Class II 1986-06-25
K861377 STANDARD/PEDIATRIC CORDIS HYDROCEPHALUS VALVES Cordis Corp. JXG Class II 1986-06-19
K862220 COMPASS CT STEREOTACTIC ADAPTATION SYSTEM Stereotactic Medical Systems, Inc. HAW Class II 1986-06-18
K860271 BIOFEEDBACK MICROLAB Hrm Software/Div. of Human Relations Media HCC Class II 1986-06-18
K853898 SKYLARK MODEL 1001 TENS DEVICE Peleg Intl. Co. GZJ Class II 1986-06-18
K861214 SKYLARK GB 1000 Peleg Intl. Co. GZJ Class II 1986-06-18
K853608 NEUROMETER Neurotron, Inc. LLN Class I 1986-06-12
K862012 LADD MEDICAL S-2000 Ladd Research Industries, Inc. GWM Class II 1986-06-09
K860914 ISOLATED SOLID-STATE RELAY MULTIPLEXER & F/F CONV Bio-Feedback Systems, Inc. GWK Class II 1986-06-06
K854665 4312P POLYSOMNOGRAPH ELECTOENCIPHALOGRAPH Nihon Kohden America, Inc. OLV Class II 1986-06-05
K860903 TM-3600 A NEURODIAGNOSTIC SYSTEM Tracor Northern, Inc. GWF Class II 1986-06-05
K861893 GGT REAGENT CARTRIDGE (PRODUCT NO. 88204) Hi Chem, Inc. JXL Class II 1986-06-05
K860829 CNS 4/8 AND CT 48.1 SOFTWARE Cns, Inc. GWS Class I 1986-05-29
K861709 A TENS (MODEL AI-86) American Imex GZJ Class II 1986-05-16
K860772 HARIKY, MODEL GK-7 K-Mot, Inc. GZJ Class II 1986-05-09
K855107 MEDTRONIC MODEL 3422A TRANSMITTER ANTENNA KIT Medtronic Vascular GZB Class II 1986-05-09
K861630 NEUROSURGICAL INSTURMENTS (VARIOUS) Downs Surgical , Ltd. HAO Class I 1986-05-09
K861501 EXER-STIM 2 Th Charters, Inc. GZJ Class II 1986-05-08
K854396 RUB E-Z E-Z Instruments Co. GYA Class I 1986-05-08
K861470 #CTO 100 (CERVICAL TRACTION ORTHOSIS 100) Applied Medical Systems HAX Class II 1986-05-02
K854334 PAINBLOCKER WA5000 Wallach Surgical Devices, Inc. GXH Class II 1986-04-30
K860457 ELECTROCARDIOGRAPH CONTINUOUS MONITOR Oxford Medilog, Inc. GWN Class II 1986-04-30
K854362 MODIFIED BRAIN ATLAS III Bio-Logic Systems Corp. GWE Class II 1986-04-22
K860240 CNS-EP SYSTEM AND EP 1.0 SOFTWARE Cns, Inc. GWF Class II 1986-04-17
K860219 SASSSY SEMI AUTOMATIC SLEEP SCORING SYSTEM Grass-Telefactor Product Group OLV Class II 1986-04-17
K860185 UNISTIM UNT-1M NEUROSTIMULATOR TRANSMITTER Neuromed, Inc. GZB Class II 1986-04-04
K854268 DEL MAR AVIONICS 5509A PHYSIOSCANNER EEG SCANNER Del Mar Avionics GWQ Class II 1986-03-27
K860128 MODAC-XXXX INTENSIVE MONITORING OF EEG Grass-Telefactor Product Group GYE Class II 1986-03-27
K854713 COTTON NEUROLOGICAL SPONGE American Silk Sutures, Inc. HBA Class II 1986-03-20
K860158 8-CHANNEL MULTIPROG IMPLANT SPINAL CORD STIMULATOR Neuromed, Inc. GZB Class II 1986-03-07
K854721 NEMECTRODYN MODEL 2 & ENDOVAC 2 Nemectron Medical, Inc. LIH Class II 1986-03-06
K853178 SIBIS SELF INJURIOUS BEHAVIOR INHIBITING SYSTEM Oxford Medilog, Inc. HCB Class II 1986-02-28
K854316 FASTENS(TM) Medical Devices, Inc. GZJ Class II 1986-02-28
K854476 KALMATE MODEL 3A Medical Technology Systems, Inc. GZJ Class II 1986-02-27
K853992 VALLEY FORGE SCIEN-TENS UNIT & ACCESS. LEAD WIRE & Valley Forge Scientific Corp. GZJ Class II 1986-02-21
K853864 INTRACRANIAL PRESSURE MONITORING KIT 070 Camino Laboratories, Inc. GWM Class II 1986-02-20
K854475 GHAJAR INTRAVENTRICULAR CATHETER GUIDE Sparta Instrument Corp. HAW Class II 1986-02-20
K854761 MINIPAC PERSONAL TOUCH (TM) Medical Devices, Inc. GZJ Class II 1986-02-14
K853420 CARTOVAR BRAIN MAPPING ELECTRODIAGNOSTICS Alvar OLT Class II 1986-02-07
K853432 5.0 IOP & 7.5 IOP PROBES Diasonics, Inc. GXW Class II 1986-02-07
K854466 BIOMAGNETIC TECHNOLOGIES NEUROMAGNEOMETER Biomagnetic Technologies, Inc. OLY Class II 1986-02-04
K853885 MODEL RF-TENS-4 TRANSCUTANEOUS ELEC. NERVE STIMULA Uniking Intl. Corp. GZJ Class II 1986-01-30
K854317 MINIPAC (TM) Medical Devices, Inc. GZJ Class II 1986-01-21
K852963 MYO-ACTUATOR Verimed Holdings, Inc. HCC Class II 1986-01-21
K854277 NEUROPATH 4000 Therapeutic Technologies, Inc. HCC Class II 1986-01-21
K854208 THE BODYLOG 500 RET THERAPEUTIC ELECTROMYOGRAPHICS Bodylog, Inc. HCC Class II 1986-01-14
K854160 CNS-16 & LTM 1.0 SOFTWARE Cns, Inc. GWS Class I 1986-01-10
K854204 DYNEX REUSABLE, SELF-ADHERING ELECTRODE W/TENS La Jolla Technology, Inc. GXY Class II 1986-01-10
K855058 EVDS, EVMDS, LDS & IVMCS CENTRAL NERVOUS SYS FLUID Cordis Corp. JXG Class II 1986-01-10
K850855 TENS GB1001 DEVICE Medicon, Inc. GZJ Class II 1986-01-09
K854657 INTRACRANIAL PRESSURE MONITORING CUP CATHETERS Cordis Corp. GWM Class II 1985-12-27
K852533 L.E.D. GOGGLES, MODEL 580-LEDGOG Bio-Logic Systems Corp. GWE Class II 1985-12-12
K853806 MA-400 EMB FEEDBACK DEVICE Spectral Data Systems HCC Class II 1985-12-10
K853442 MODEL 804 (TENS) Oriental Medical Supplies, Inc. GZJ Class II 1985-12-09
K853836 NEURO PULSE II Nagata Engineering Co. GZJ Class II 1985-12-09
K854513 EMPI, NMS/SUE CUTANEOUS ELECTRODE Empi GXY Class II 1985-12-06
K853719 TRANSCUTANEOUS ELECT. NERVE STIMUL-MYOSTIM 410 Electro Therapeutic Devices, Inc. GZJ Class II 1985-12-04
K853718 TRANSCUTANEOUS ELECTR. NERVE STIMUL MYOSTIM 804 Electro Therapeutic Devices, Inc. GZJ Class II 1985-12-04
K853633 TENS CONDUCTIVE MEDIA PAD Alternative Design Systems, Inc. GXY Class II 1985-12-03
K851190 NYSTAGMOGRAPH EOG/ENG ANALYSES Nicolet Biomedical Instruments GWN Class II 1985-11-27
K854474 EXTERNAL VENTRICULAR DRAINAGE/MONITORING/LUMBAR SE Cordis Corp. JXG Class II 1985-11-27
K854049 HEYER-SCHULTE SYRINGO PERITONEAL SHUNT American V. Mueller JXG Class II 1985-11-27
K851735 SYS STIM 206 MODEL ME206 Mettler Electronics Corp. GZJ Class II 1985-11-19
K853643 MULTISTIM LAMINECTOMY ELECTRODE Neuromed, Inc. GZB Class II 1985-11-14

6,130 clearances in the Neurology panel. Data: openFDA.