meddevicedb.com FDA Device Reference

Review Panel

Neurology FDA 510(k) Clearances & Devices

Cleared Devices
6,130
Product Codes (page)
30
Latest Decision
1985-11-14

Clearances · page 56 of 62

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K852326 UNISTIM UNT-1 Neuromed, Inc. GZB Class II 1985-11-14
K853416 MES-TENS(TENS) Oriental Medical Supplies, Inc. GZJ Class II 1985-11-07
K853161 THE VICKERS STANDARD MICROSURGERY SET Keeler Instruments, Inc. GZX Class I 1985-11-07
K853179 VICKERS ERGOMATIC MICROSUR INSTRU-UNIV R O L HAND Keeler Instruments, Inc. GZX Class I 1985-11-07
K853180 VICKERS ERGOMATIC MICROS INSTR-LONG R OR L HANDED Keeler Instruments, Inc. GZX Class I 1985-10-28
K853412 WAVE GATE Wolfline Corp. GWE Class II 1985-10-28
K853181 VICKERS ERGOMATIC MICROS INSTR-FINE R OR L HANDED Keeler Instruments, Inc. GZX Class I 1985-10-28
K852920 QUADRA CATH ELECT(3MM SIZES) 1990J, JF, JP + JPF Neuromed, Inc. GZB Class II 1985-10-10
K853552 SENTRY FLEXIBLE TENS Sentry Medical Products, Inc. GXY Class II 1985-09-26
K852687 ALGO I Algotek, Inc. GWJ Class II 1985-09-18
K853371 H-H ATRIAL CATHETERS & PERITONEAL CATHETERS Holter-Hausner Intl. JXG Class II 1985-09-18
K853370 H-H CATHETER PASSERS(TACL DESIGN Holter-Hausner Intl. GYK Class I 1985-09-18
K853215 ACCU-FLO PRESSURE VALVE Codman & Shurtleff, Inc. JXG Class II 1985-09-16
K853367 H-H BURR HOLE CATHETER SUPPORT Holter-Hausner Intl. GXR Class II 1985-09-11
K853369 H-H FIXATION & JOINING CONNECTORS Holter-Hausner Intl. JXG Class II 1985-09-11
K853366 H-H UNITIZED STANDARD SHUNT/RESERVOIR SHUNT Holter-Hausner Intl. JXG Class II 1985-09-11
K853368 H-H SHUNT INTRODUCER Holter-Hausner Intl. GYK Class I 1985-09-06
K853365 H-H FIFTH VENTRICLE Holter-Hausner Intl. JXG Class II 1985-09-05
K853364 H-H RICKHAM TYPE RESERVOIR Holter-Hausner Intl. JXG Class II 1985-09-05
K850646 ECLIPSE SELF ADHERING ELECTRODE Todd Medical, Inc. GXY Class II 1985-09-03
K853363 H-H CRUCIFORM-SLIT VALVE Holter-Hausner Intl. JXG Class II 1985-09-03
K853362 H-H SLOTTED VENTRICULAR CATHETER/SLOTTED CATHETER Holter-Hausner Intl. JXG Class II 1985-09-03
K853361 H-H VENTRICULAR CATHETERS & RESERVOIRS Holter-Hausner Intl. JXG Class II 1985-08-28
K852837 ADVANCED MEDICAL PRODUCTS DR PULSE (TENS) Advanced Medical Products, Inc. GZJ Class II 1985-08-28
K852836 ADVANCED MEDICAL PRODUCTS MINI-M (TENS) Advanced Medical Products, Inc. GZJ Class II 1985-08-28
K852838 ADVANCED MEDICAL PRODUCTS MES TENS Advanced Medical Products, Inc. GZJ Class II 1985-08-28
K852662 GOUDA FRAME FOR STEREOTACTIC NEUROSURGERY Neurosurgical Devices, Inc. HAW Class II 1985-08-21
K844618 BIO-TENS Bio-Research Associates, Inc. GZJ Class II 1985-08-21
K844566 ICP MONITOR MODEL 1000 Advanced Ultrasonic Testing & Research Corp. GWM Class II 1985-08-16
K852587 CDSA(COLOR DENSITY, SPECTRAL ARRRAY) Tracor Northern, Inc. OLT Class II 1985-08-16
K852827 CORDIS EXTERNAL NEURAL STIMULATOR MODEL 911A Cordis Corp. GZB Class II 1985-08-14
K852956 CONTACT CONDUCTIVE ADHESIVE GEL COMPOSITION Parker Laboratories, Inc. GYB Class II 1985-08-09
K852069 MECTA ECT DEVICE MODELS SR & JR Mecta Corp. QGH Class II 1985-08-09
K853066 MAYFIELD DISPOSABLE SKULL PINS Codman & Shurtleff, Inc. HAX Class II 1985-08-08
K850541 SLEEP STAGER Oxford Medilog, Inc. OLT Class II 1985-08-02
K850342 WYLER SUBDURAL STRIP ELECTRODE Ad-Tech Medical Instrument Corp GYC Class II 1985-07-30
K852477 KELLY-GROERSS-KALL CT STEROTACTIC ADAPTATION SYS Mayo Clinic HAW Class II 1985-07-30
K845035 ELECTRODE FOR NEUROLOGICAL SURGERY 2111 Progress Mankind Technology GYC Class II 1985-07-30
K852716 TAYLOR PERCUSSION HAMMER SS 410 OR 420 The Huxley Instrument Corp. GWZ Class I 1985-07-26
K851973 DIASONICS, BERGER STEREOTACTIC NEOROBIOPSY Diasonics, Inc. HAW Class II 1985-07-26
K850180 ELECTRONYSTAGMOGRAPH (ENG RECORDER) Bio-Logic Systems Corp. GWN Class II 1985-07-22
K850430 NEUROSCIENCE MAP-10 EEG Neuroscience, Inc. GWS Class I 1985-07-17
K850785 FASTUBE NERVE REGENERATION DEVICE Research Medical, Inc. JXI Class II 1985-07-10
K851511 ACCURATECARE I & ACCURATECARE II Sunnex, Inc. GZJ Class II 1985-07-01
K851659 SKULL MOUNTED STEREOTACTIC SURGICAL DEVICE Medco Products, Co., Inc. HAW Class II 1985-07-01
K852298 TENS-AID STERILE ELECTRODES FOR POST-OP TENS Staodynamics, Inc. GXY Class II 1985-06-24
K852267 ELECTRICAL NERVE STIMULATION(TENS) ELECTRODES Axelgaard Mfg. Co., Ltd. GXY Class II 1985-06-18
K851175 TRANSCUTANEOUS ELECTRICAL NERVE STIMULA-ELECTORDE Medical Devices, Inc. GXY Class II 1985-06-18
K850418 BUSHEL OFF-HEAD PREAMPLIFIER Oxford Medilog, Inc. GWQ Class II 1985-06-13
K851232 TECA MONTAGE II Teca, Inc. GWQ Class II 1985-06-13
K851749 1-380 PINWHEEL (WARTENBERG) Artiberia GWY Class I 1985-06-13
K844594 NEURO CUSTOM SURGICAL KIT Xanmed Corp. HBA Class II 1985-06-13
K851300 NEUROPACK 8, MEE-4108 Nihon Kohden America, Inc. GWF Class II 1985-06-13
K851748 1/310, 1-320 PERCUSSION HAMMERS,TAYLOR, DEJERINE Artiberia GWZ Class I 1985-06-13
K844992 BIO-LOGIC PORTABLE EVOKED RESPONSE SYSTEM Bio-Logic Systems Corp. GWF Class II 1985-06-07
K851063 TENSMED II Intermedics, Inc. GZJ Class II 1985-06-04
K850109 NOMAD TM-3400 Tracor Northern, Inc. GWF Class II 1985-06-04
K850860 AXON II BRAND OF DUAL CHANNEL TENS Cassandra Electronics Corp. GZJ Class II 1985-05-31
K850849 MYOMETER EMG BIOFEEDBACK DEVICE Physio Technology, Inc. HCC Class II 1985-05-31
K843815 EVOMATIC 8000/4000 Dantec Electronics, Inc. GWF Class II 1985-05-31
K851191 ELECTRO-NERVE STIMULATOR DISCO B9 TENS Biomedical Life Systems, Inc. GZJ Class II 1985-05-31
K850759 COMPUTER INTERFACE - BIOFEEDBACK M.O.E Electronics Research & Prod. HCC Class II 1985-05-23
K851185 ELECTRO-NERVE STIMULATOR B4/B400 Biomedical Life Systems, Inc. GZJ Class II 1985-05-23
K851303 COMFORT-EASE ELECTRODE Medtronic Vascular GXY Class II 1985-05-23
K844707 QUANTUM 84 Cadwell Laboratories, Inc. GWF Class II 1985-05-21
K844481 NEUROLAB II Teca, Inc. GWS Class I 1985-05-20
K850642 TEMP/SC 200T -SKIN CONDUCTANCE/SKIN TEMP BIOFEEDBA Thought Technology , Ltd. HCC Class II 1985-05-17
K850643 HR/BVP 100T HEART RATE MONITOR Thought Technology , Ltd. HCC Class II 1985-05-17
K850107 CONCENTRIC NEEDLE ELECTRODES-VARIOUS SIZES W/CONNE Nicolet Biomedical Instruments GXZ Class II 1985-04-11
K843598 BRAIN FUNCTION MAPPING OPTION FOR PATHF Nicolet Biomedical Instruments GWK Class II 1985-04-11
K850259 ELECTROENCEPHALOGRAPH EEG Nicolet Biomedical Instruments GWQ Class II 1985-04-11
K850108 EMG SURFACE, DIGITAL RING, BAR, GROUNDING, EEG Nicolet Biomedical Instruments GXY Class II 1985-04-11
K844680 CYBERTENS Pori Associates, Inc. GZJ Class II 1985-04-05
K843712 AUDIT TM V Axonics, Inc. GWF Class II 1985-04-05
K850004 TRANSCUTANEOUS NERVE STIMULATOR FOR PAIN RELIEF Todd Medical, Inc. GZJ Class II 1985-04-02
K841871 LIQUA-SONIC GEL Chester Labs, Inc. GYB Class II 1985-03-14
K843924 DIGITAL ELECTRONEUROMETER S-100 Neurotron, Inc. JXE Class II 1985-03-12
K844994 THE MEHESZ STIMULATING SYSTEM Campden Medical , Ltd. GZJ Class II 1985-03-06
K850311 DISPOS. CONDUCTIVE ADHESIVE TENS PAD Consolidated Medical Equipment, Inc. GXY Class II 1985-03-05
K841427 ACCU-O-MATIC Myomed, Inc. GZJ Class II 1985-03-05
K850131 CONDUCTIVE ADHESIVE POST-OP ELECTRODE-TENS Consolidated Medical Equipment, Inc. GXY Class II 1985-03-05
K844681 EMG REPORT GENERATOR Microsystem Controls JXE Class II 1985-02-26
K844659 VPS 2250, CSU2250 & VFU 2250 Madsen Electronics (Canada) , Ltd. GWE Class II 1985-02-25
K843964 TENS-AID PREMIUM ELECTRODES Staodynamics, Inc. GXY Class II 1985-02-25
K844616 SIEGEN VISUAL STIMULATOR Siegen Corp. GWE Class II 1985-02-14
K844115 MEDTRONIC 3465 SE-4F RECEIVER/EXTENSION FOR SPINAL Medtronic Vascular GZB Class II 1985-02-06
K844098 CANMED 103 Medtronic Vascular GXY Class II 1985-02-04
K844023 AQUAFORM ELECTRODES WITH AQUAPORE Biostim, Inc. GXY Class II 1985-02-01
K844352 SUNDT-KEES REINFORCING ANEURYSM CLIP Kees Surgical Specialty Co., Inc. HCH Class II 1985-01-24
K844279 INTERCEPTOR, 662-01 Intermedics, Inc. GZJ Class II 1985-01-24
K844120 ULTRASONIC SCANNER CALIBRATION & TEST OBJECTS Echo Ultrasound GXX Class I 1985-01-23
K844076 ELECTRO-NERVE STIMULATOR B5/SK700B Biomedical Life Systems, Inc. GZJ Class II 1985-01-23
K844247 ULTRASONIC SCANNER CALIBRATION & TEST PHANTOMS Technicare Corp. GXX Class I 1985-01-23
K844216 GRASS MODEL NL FACIAL NERVE LOCATOR & MONITOR Grass Instrument Co. JXE Class II 1985-01-18
K842888 DUAL CHANNEL TENS, PULSAR REMOTE CONTRL Cryomedics, Inc. GZJ Class II 1985-01-14
K844213 STIMTECH SD PATIENT 6089 #78-8050 Codman & Shurtleff, Inc. GZJ Class II 1985-01-10
K842784 CEREGROTRAC Advanced Instruments, Inc. GWQ Class II 1985-01-10
K844212 STIMTECH SD CLINICIAN 6090 #78-8055 Codman & Shurtleff, Inc. GZJ Class II 1985-01-10
K844638 ELECTROCAINE MODEL SR-IV Electrocaine Medical System GZJ Class II 1985-01-08
K842964 PHOTIC STIMULATOR TM-3030-70 Tracor Northern, Inc. GWE Class II 1984-12-28

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