meddevicedb.com FDA Device Reference

Review Panel

Neurology FDA 510(k) Clearances & Devices

Cleared Devices
6,130
Product Codes (page)
28
Latest Decision
1981-03-13

Clearances · page 60 of 62

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K810593 NEUROPAC ULTRA I Medical Devices, Inc. GZJ Class II 1981-03-13
K810481 VISUAL PATTERN REVERSAL GEN. & PHOTIC S. Amplaid USA, Inc. GWE Class II 1981-03-11
K810262 AUTOMATIC ELECTRODE PLACEMENT BELT Wallant Intl. Trade, Inc. GXY Class II 1981-03-11
K803099 BIOFEEDBACK BIO 80 Bimed, Inc. HCC Class II 1981-03-02
K810485 DUJOVNY MICROSURGICAL SCISSORS American V. Mueller GZX Class I 1981-02-27
K810319 CORDIS STIMUCORD EXTERNAL NEUTRAL STIM Cordis Corp. GZB Class II 1981-02-19
K803226 EVOKED RESPONSE STIMULATORS Bio-Logic Systems Corp. GWK Class II 1981-02-05
K810054 RICA (DIAGNOSTIC INSTRUMENTS) Robert I. Chien & Assoc., Inc. GWZ Class I 1981-01-28
K803257 CSG-FLOW CONTROL VALVE Pudenz-Schulte Medical Research Corp. JXG Class II 1981-01-22
K803233 MEUROMETRICS MONITOR Dade Medical, Inc. GWS Class I 1981-01-12
K802391 EMG-UT 40 American Scientific Corp. HCC Class II 1981-01-09
K802390 EMG-UT 30 American Scientific Corp. HCC Class II 1981-01-09
K803148 CONPHAR PERCUSSION HAMMER(TAYLOR) Conphar, Inc. GWZ Class I 1981-01-08
K802647 ECA GEL PROUDUCT REFORMULATION Vanaray Laboratories, Inc. GYB Class II 1981-01-08
K803113 MENTOR 402 TRANSCUTANEOUS ELEC. STIMULAT George H. Frisch GZJ Class II 1980-12-30
K803121 MENTOR 150 TRANSCUTANEOUS NERVE STIMULA George H. Frisch GZJ Class II 1980-12-30
K802658 RODEL ELECTRODERM PADS Rodel Products Corp. GYB Class II 1980-12-30
K803151 ECG & ULTRASOUND GELS, CREAMS & LOTION Abco Dealers, Inc. GYB Class II 1980-12-30
K803174 CONPHAR PERCUSSION HAMMER(BUCK TYPE) Conphar, Inc. GWZ Class I 1980-12-30
K803012 SHUR-PATCH TAPE PATCH Shur Medical Corp. GXY Class II 1980-12-30
K802586 AMERICAN HEYER-SCHULTE LOW PROFILE VALVE American Heyer Schulte JXG Class II 1980-12-18
K802887 MODEL EEG 4221 Nihon Kohden America, Inc. GWQ Class II 1980-12-16
K802678 TRANSCUTANEOUS ELECTRIC NERVE STIMULATOR General Medical Industries, Inc. GZJ Class II 1980-12-10
K802779 LOAD SENTINEL II, TRANS. ELEC. NERVE Powers Medical Systmes GZJ Class II 1980-12-10
K802507 TENSMATE EMPIMODEL 9980 Empi GZJ Class II 1980-12-01
K802656 MODEL T-6 EEG TELEPHONE TRANSMITTER Telediagnostic Systems, Inc. GYE Class II 1980-11-26
K802648 UCA CREAM PRODUCT REFORMULATION Vanaray Laboratories, Inc. GYB Class II 1980-11-26
K802152 PMT DEPTHALON DEPTH #2102 Progress Mankind Technology GZL Class II 1980-11-19
K802249 MICROLET FAMILY OF NEEDLE/DEPTH ELECT- Progress Mankind Technology GZL Class II 1980-11-19
K802726 INSTRUMENTS NONSTERILE & STERILE Ascep, Inc. HAO Class I 1980-11-19
K802151 PMT DEPTHALON DEPTH CORTICOGRAPHY ELEC Progress Mankind Technology GZL Class II 1980-11-19
K802649 UCA GEL PRODUCT REFORMAULATION Vanaray Laboratories, Inc. GYB Class II 1980-11-12
K802149 TM-5 INTRACRANIAL PRESSURE MONITOR Nicolet Biomedical Instruments GWM Class II 1980-11-12
K802696 DENTAL MOUTH PROP. Trident Dental, Inc. JXL Class II 1980-11-12
K802657 MODEL AFR EEG TELEPHONE RECEIVER Telediagnostic Systems, Inc. GYE Class II 1980-11-12
K802650 UCA LOTION PRODUCT REFORMULATION Vanaray Laboratories, Inc. GYB Class II 1980-11-12
K802243 VAXIOM FAMILY OF RF LESION PROBES & ELEC Progress Mankind Technology GXI Class II 1980-11-12
K802137 CHEEK EPIDURAL SCREW Codman & Shurtleff, Inc. GWM Class II 1980-10-31
K802138 CHEEK TOOL SET Codman & Shurtleff, Inc. GWM Class II 1980-10-31
K802296 MINGOGRAF EEG10 Siemens Corp. GWQ Class II 1980-10-03
K802063 SPEMBLY 9000 & 9300 Spembly Medical , Ltd. GZJ Class II 1980-10-03
K802292 MINGOGRAF EEG21 Siemens Corp. GWQ Class II 1980-10-03
K802227 ANASTIM II TRANSCUTANEOUS ELECTRICAL Biostim, Inc. GZJ Class II 1980-09-26
K801907 ALGESIOMETER Rowan Products, Inc. GXB Class I 1980-09-16
K802100 INTRACRANIAL PRESSURING MONITORING SYST. Pudenz-Schulte Medical Research Corp. GWM Class II 1980-09-16
K801760 FIELD-LEE BRAIN BIOPSY NEEDLE American V. Mueller HAO Class I 1980-09-09
K801459 ELECTRO-ACUSCOPE-70 Nebrensky Corp. GZJ Class II 1980-08-20
K801576 NEUROGAR III-TRANSCUT. ELEC. NERVE STIM Inter Med Industries, Inc. GZJ Class II 1980-08-14
K801855 CYCLOPAC TENS Dow Corning Wright GZT Class II 1980-08-13
K801755 MMI/GAELTEC CATHETER TIP PRESSURE Medical Measurements, Inc. GWM Class II 1980-08-13
K801671 ESG-1 (EVOKED RESPONSE STIMULUS GENER) Neurodiagnostics, Inc. GWE Class II 1980-08-04
K801670 NDI-IKE EMG Neurodiagnostics, Inc. GWK Class II 1980-08-04
K801604 PATHFINDER ELECTRODIAGNOSTIC SYSTEM Nicolet Biomedical Instruments GWK Class II 1980-08-04
K801384 MYELOSTAT DORSAL CORD STIMULATOR, ETC. Medtronic Vascular GZB Class II 1980-07-08
K801049 V.I.B.E. VIDEO INTERFACE BIOFEEDBACK EQU Nebulae Productions HCC Class II 1980-06-26
K801383 ECA CREAM REFORMULATION Vanaray Laboratories, Inc. GYB Class II 1980-06-17
K800576 CYCLOPAC CP100 TENS BANDAGE Cyclotechnical Medical Indust., Inc. GZJ Class II 1980-05-23
K801151 DISPOSABLE SKIN RETRACTOR Cimarron Instruments, Inc. GZT Class II 1980-05-20
K801112 EMPI MODEL 910S, TENS Empi GZJ Class II 1980-05-14
K800758 TENZCARE DUAL-CHANNEL STIMULATOR 3M Company GZJ Class II 1980-04-10
K800452 NEUROMETRICS MONITOR Neurometrics GWS Class I 1980-04-02
K800630 TYPE 4000 TRANSCUTANEOUS ELEC. STIM. Frye Electronics, Inc. GZJ Class II 1980-04-02
K800380 FES ORTHOSIS MODEL NO. 2000 Empi GZI Class II 1980-03-17
K792115 BIOFEEDBACK DEVICES & ACCESSORIES M.O.E Electronics Research & Prod. HCC Class II 1980-03-03
K800319 ALPHA DETECTOR M.O.E Electronics Research & Prod. HCC Class II 1980-03-03
K800369 TRI PAC MOUTH PROP Oxequip Health Ind. JXL Class II 1980-02-28
K800117 TRU-PULSE PADS Ipco Corp. GXY Class II 1980-02-11
K800193 MEDTRONIC PISCES GENERATION II LEAD KIT Medtronic Vascular GZB Class II 1980-02-05
K792488 ECA GEL Vanaray Laboratories, Inc. GYB Class II 1980-02-05
K792491 ECA CREAM Vanaray Laboratories, Inc. GYB Class II 1980-02-05
K800001 MINI-CEARS COMPUTER (MODEL 1) Bik Foundation, Inc. GWS Class I 1980-01-31
K800168 H-H FIFTH VENTRICLE Holter-Hausner Intl. JXG Class II 1980-01-31
K792371 TELEMETRY SYSTEM XMT-1 & REC-1 Burdick Corp. GYE Class II 1980-01-31
K792007 CSF-VENTRICULAR CATHETER, STANDARD DES Pudenz-Schulte Medical Research Corp. JXG Class II 1980-01-16
K792005 CSF-CARDIAC/PERITONEAL CATHETER Pudenz-Schulte Medical Research Corp. JXG Class II 1980-01-16
K792659 FEEDBACK EDR SYSTEM MODEL ME-1 Bio-Feedback Systems, Inc. HCC Class II 1980-01-09
K792380 CMS 6000 Physio-Control Corp. GYE Class II 1980-01-04
K792639 H-H SHUNT INTRODUCER Holter-Hausner Intl. GYK Class I 1979-12-31
K792586 HALO SUPPORT JACKET & ASSOC. HARDWARE Depuy, Inc. HAX Class II 1979-12-31
K792473 THERAPETTE, MODEL NO MH-100 Technical Resources, Inc. GZJ Class II 1979-12-20
K792305 A SLEEP ASSESSMENT DEVICE Farrall Instruments, Inc. LEL Class II 1979-12-20
K792502 TENS 4100 Staodynamics, Inc. GZJ Class II 1979-12-18
K792522 MODEL 980D TENS NEUROPACER Empi GZJ Class II 1979-12-13
K792474 TENS 4500 Staodynamics, Inc. GZJ Class II 1979-12-13
K792351 MEDTRONIC MOD. 3852 STERIL-ICE ELECTRODE Medtronic Vascular GXY Class II 1979-12-05
K792311 MEDTRONIC MODEL 7728 NEUROMOD Medtronic Vascular GZJ Class II 1979-11-21
K792157 DENTAL MOUTHPROP (BITE BLOCK) Mission Dental, Inc. JXL Class II 1979-11-13
K792085 C-ERA-100 COMPUTERIZED ELECTRIC RESPON Micro-Shev , Ltd. GWJ Class II 1979-10-30
K791833 NURITE II VRM SINGLE (ELEC. NERVE STIM) Bio-Medical Systems Corp. GZJ Class II 1979-10-02
K791834 NURITE II VRM DUAL (ELEC. NERVE STIM.) Bio-Medical Systems Corp. GZJ Class II 1979-10-02
K791764 SCOVILLE-LEWIS ANEURYSM CLIPS Codman & Shurtleff, Inc. HCH Class II 1979-10-01
K791013 SPECTRA R PAD Parker Laboratories, Inc. GYB Class II 1979-09-17
K791149 STIMULATOR MODEL SSS-1101 Nihon Kohden America, Inc. GWE Class II 1979-09-17
K791150 ELECTROENCEPHALOGRAPHS MODELS 7209,7213 Nihon Kohden America, Inc. GWQ Class II 1979-09-12
K791234 MODEL EEG-4217 ELECTROENCEPHALOGRAPH Nihon Kohden America, Inc. GWQ Class II 1979-09-12
K791233 MODEL EEG-4214 ELECTROENCEPHALOGRAPH Nihon Kohden America, Inc. GWQ Class II 1979-09-12
K791580 CEREBRAL FUNCTION MONITOR 870 Applied Medical Research OMA Class II 1979-09-04
K791207 APOLLO HEART RATE INDICATOR Key Tronic Corp. HCC Class II 1979-08-28
K791101 DISPOSABLE PERFORATORS, JACOBS, HUDSON Codman & Shurtleff, Inc. HBF Class II 1979-08-28
K791187 MODEL 810 VERI/TGS Verite GZJ Class II 1979-08-22

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