meddevicedb.com FDA Device Reference

Review Panel

Neurology FDA 510(k) Clearances & Devices

Cleared Devices
6,130
Product Codes (page)
29
Latest Decision
1995-01-30

Clearances · page 46 of 62

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K945676 GUARDIAN DISPOSABLE TENS AND TENS/NMES ELECTRODES Selectivemed Components, Inc. GZJ Class II 1995-01-30
K950127 ALTERNATE 100% ETO STERILIZATION PROCESS AND ALTERNATE STERILIZATION FACCILITY Medtronic Vascular GZB Class II 1995-01-30
K940970 YASARGIL, CASPAR, VARIO CLIP APPLIERS Aesculap, Inc. HCI Class II 1995-01-24
K943468 LEKSELL SURGIPLAN Elekta Instruments, Inc. HAW Class II 1995-01-20
K944061 CUEVA CRANIAL NERVE ELECTRODE Ad-Tech Medical Instrument Corp GZL Class II 1995-01-20
K935853 EMG TRAINER Unitech HCC Class II 1995-01-18
K941551 THE VANGUARD SYSTEM Cleveland Clinic Foundation GWQ Class II 1995-01-13
K945040 HAMID HOOK ATTACHMENT DEVICE FOR HEMILAMINECTOMY RETRACTOR Hamid M. Mehdizadeh, M.D. GZT Class II 1995-01-13
K945103 TEMP AND PERMANENT NEURO LEADS (VARIOUS MODELS) Medtronic Vascular GZB Class II 1995-01-11
K936039 ALGO-2 NEWBORN HEARING SCREENER Natus Medical, Inc. GWJ Class II 1995-01-05
K933808 EEG CUP ELECTRODE Cadwell Laboratories, Inc. GXY Class II 1994-12-29
K933796 EEG NEEDLE ELECTRODE Cadwell Laboratories, Inc. GXZ Class II 1994-12-29
K933805 RING ELECTRODE Cadwell Laboratories, Inc. GXY Class II 1994-12-19
K930536 NEUROMED OCTRODE MODEL MNR-88A-B-C NEUROSTIM REC Neuromed, Inc. GZB Class II 1994-12-15
K944603 CONMED VERSA STEM NEUROMUSCULAR STIMULATION/TENS Conmedcorp GXY Class II 1994-12-15
K926312 INFRARED EYE MOVEMENT MONITOR Microguide, Inc. GWN Class II 1994-12-15
K944354 CONTOUR EMBOLI Interventional Therapeutics Corp. HCG Class II 1994-12-13
K930498 NEUROMED OCTRODE MODEL MNT-98 NEUROSTIMULATOR TRAN Neuromed, Inc. GZB Class II 1994-12-12
K943635 ULTRA-LINE RONGEUR V. Mueller Neuro/Spine HAE Class II 1994-12-07
K943987 OPX-VX FEBEROPTIC INTRACRANIAL PRESSURE MONITORING CATHETER WITH DRAINAGE Innerspace Medical, Inc. GWM Class II 1994-12-07
K940012 SMARTBRACE ELECTRODE Medical Devices, Inc. GXY Class II 1994-12-05
K943126 ELECTROFLEX Medical Devices, Inc. GXY Class II 1994-12-05
K911820 GED (GRADUATED ELECTRONIC DECELERATOR Behavior Research Institute, Inc. HCB Class II 1994-12-05
K942413 CLARUS ENDOSCOPIC NEUROLOGICAL TISSUE ELEVATOR Clarus Medical Systems, Inc. GWG Class II 1994-11-22
K944311 ACRA-CUT Acra Cut, Inc. HBO Class II 1994-11-18
K935560 PMT EXTERNAL EXTERNAL DRAINAGE SYSTEM (EDS) Pmt Corp. JXG Class II 1994-11-07
K941568 K-10-VS, DA-05-VS, RECORDING ELECTRODES Medicotest, Inc. GXY Class II 1994-11-04
K942249 CLARUS NEUROPEN MODEL 2120 Clarus Medical Systems, Inc. GWG Class II 1994-11-04
K943673 MMC AMPLIFIER Melville Software , Ltd. GWL Class II 1994-10-26
K933801 ELECTRODE, CUTANEOUS Cadwell Laboratories, Inc. GXY Class II 1994-10-21
K942461 NEUROLOGY ACCESSORIES - MARK-EASY 10-20 Optimit USA, Inc. GXY Class II 1994-10-19
K934580 DANTEC 13R45 BAR ELECTRODE Dantec Medical, Inc. GXY Class II 1994-09-26
K942718 CLOTH TENS/BNES ELECTRODE Conmed Andover Medical, Inc. GXY Class II 1994-09-22
K933237 MEDI-STIM, MODIFICATION Mid-Canada Medical GZJ Class II 1994-09-08
K933802 CUTANEOUS ELECTRODE Cadwell Laboratories, Inc. GXY Class II 1994-09-07
K922270 PHYSIOTECH 4000 OR NORODYN 8000 Myo-Tronics, Inc. HCC Class II 1994-09-02
K934368 NK PRESSURE-SPECIFIED SENSORY DEVICE, MODEL PSSD-001 Nk Biotechnical Engineering Co. LLN Class I 1994-08-11
K941938 THE MIRAGE SYSTEM BIOFEEDBACK INTERFACE Intercare Diagnostics, Inc. HCC Class II 1994-08-05
K942926 NEURO-AIDE Burke Neutech, Inc. GWY Class I 1994-08-03
K935298 INSTA-NERVE(TM) NERVE CONDUCTION MONITOR Insta Nerve Canada, Inc. JXE Class II 1994-08-03
K942955 DISPOSABLE BIPOLAR ELECTRODE Neuro Navigational Corp. GWG Class II 1994-08-03
K932868 THERATOUCH 4.7 Rich-Mar Corp. LIH Class II 1994-07-29
K935017 TD50 ELECTROMYOGRAPH Medelec Intl. Corp. JXE Class II 1994-07-28
K943116 AUTO SUTURE KERRISON SPINAL RONGEUR United States Surgical, A Division of Tyco Healthc HAE Class II 1994-07-27
K933807 GROUND PLATE ELECTRODE Cadwell Laboratories, Inc. GXY Class II 1994-07-26
K943115 AUTO SUTURE PITUITARY SPINAL RONGEUR United States Surgical, A Division of Tyco Healthc HAO Class I 1994-07-25
K942968 AUTO SUTURE SPINAL OSTEOTOME United States Surgical, A Division of Tyco Healthc HAO Class I 1994-07-20
K942967 AUTO SUTURE SPINAL CURETTE United States Surgical, A Division of Tyco Healthc HAO Class I 1994-07-20
K942970 AUTO SUTURE SPINAL ELEVATOR United States Surgical, A Division of Tyco Healthc HAO Class I 1994-07-20
K932429 CORDIS GRAVITY COMPENSATING ACCESSORY Cordis Corp. JXG Class II 1994-07-20
K942969 AUTO SUTURE SPINAL NERVE HOOK United States Surgical, A Division of Tyco Healthc HAO Class I 1994-07-20
K942971 AUTO SUTURE SPINAL DISSECTOR United States Surgical, A Division of Tyco Healthc HAO Class I 1994-07-20
K940416 NEUROLOGICAL LEADS (PACKAGING MODIFICATION) Medtronic Vascular GZB Class II 1994-07-18
K934051 BIO SDP (AKA SATURN SD, GLC-III SD & STAT-SD) Skylark Device Co., Ltd. GZJ Class II 1994-07-11
K936099 NEUROLOGICAL LEAD ACCESSORIES Medtronic Vascular GZB Class II 1994-07-11
K941239 AESCULAP NEUROENDOSCOPE Aesculap, Inc. GWG Class II 1994-07-11
K933803 DISPOSABLE TAB ELECTRODE Cadwell Laboratories, Inc. GXY Class II 1994-07-08
K922106 ALICE Healthdyne, Inc. OLV Class II 1994-07-06
K932897 TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR Nemectron GmbH GZJ Class II 1994-07-01
K932299 ELECTRO-MESH Prizm Medical, Inc. GXY Class II 1994-07-01
K936101 CONMED VERSA-STIM NEUROMUSCULAR STIMULATION ELECTRODE Conmedcorp GXY Class II 1994-06-30
K940704 CONMED VERSA-STIM INTERFERENTIAL ELECTRODE Conmedcorp GXY Class II 1994-06-22
K934938 TEMPORARY SCREENING LEAD/CATHETER KIT Medtronic Vascular GZB Class II 1994-06-14
K930535 IF400 Skylark Device Co., Ltd. LIH Class II 1994-06-14
K930263 MATRIX PRO-ELECDT Matrix Electromedical, Inc. LIH Class II 1994-06-09
K931079 STAT-TENS Skylark Device Co., Ltd. GZJ Class II 1994-06-09
K933368 TENS-IT Electro Med Supply, Inc. GZJ Class II 1994-06-07
K933799 TEN-20 CONDUCTIVE PASTE GEL Cadwell Laboratories, Inc. GYB Class II 1994-05-27
K935324 THERAPEUTIC ULTRASOUND AND STIMULATOR Chattanooga Group, Inc. GZJ Class II 1994-05-26
K934670 DG 3P SYSTEM Medelec , Ltd. GWQ Class II 1994-05-25
K933797 OMNI PREP GEL Cadwell Laboratories, Inc. GYB Class II 1994-05-17
K932202 MODEL 3862A & B 3863A & B TEMP. LEAD SCREENING KIT Medtronic Vascular GZB Class II 1994-05-04
K935861 MEDNEXT BUR Mednext, Inc. HBE Class II 1994-05-03
K940096 PS MEDICAL CATHETER PLACEMENT KIT Pudenz-Schulte Medical Research Corp. GWG Class II 1994-05-03
K934545 PS MEDICAL DELTA BURR HOLE VALVE Pudenz-Schulte Medical Research Corp. JXG Class II 1994-04-28
K933795 CONCENTRIC EMG NEEDLE ELECTRODE Cadwell Laboratories, Inc. GXZ Class II 1994-04-22
K933806 MONOPOLAR EMG NEEDLE ELECTRODE Cadwell Laboratories, Inc. GXZ Class II 1994-04-22
K933798 NU-PREP GEL Cadwell Laboratories, Inc. GXB Class I 1994-04-22
K933793 GROUND/REFERENCE NEEDLE ELECTRODE Cadwell Laboratories, Inc. GXZ Class II 1994-04-19
K935395 NEURON II AND MICROTENS Datran Corp. GZJ Class II 1994-04-15
K913556 IVALON EMBOLIZATION PARTICLES Ivalon HCG Class II 1994-04-13
K934196 CODMAN QUICK SHUNT KIT, CAT. #82-6570 Codman & Shurtleff, Inc. GWG Class II 1994-04-12
K932533 SMARTSCOPE Insight Medical Corp. JXE Class II 1994-03-31
K925111 HOUSE INFRARED/VIDEO ELECTRONYSTAGMOGRAPH SYSTEM Eye Dynamics, Inc. GWN Class II 1994-03-23
K930102 PULSATOR 5000 Toys House Industrial Corp. GZJ Class II 1994-03-23
K932407 CADWELL EASY WRITER AND EASY READER Cadwell Laboratories, Inc. GWQ Class II 1994-03-22
K935529 CERVICAL SELF-RETAINING RETRACTOR T. Korossurgical Instruments Corp. GZT Class II 1994-03-22
K936019 NOMOS STEREOTACTIC BIOPSY INSTRUMENTS Nomos Corp. HAW Class II 1994-03-22
K933804 LECTRON II CONDUCTIVE GEL/CADWELL ELECTRODE GEL Cadwell Laboratories, Inc. GYB Class II 1994-03-22
K932592 BRACE NEUTRALIZER Smith and Nephew Donjoy, Inc. GZJ Class II 1994-03-18
K935132 HOME MICROCURRENT HMC Medical Devices, Inc. GZJ Class II 1994-03-14
K931732 VIFI: VECTOR INTERFERENTIAL ONE Compliance Technology, Inc. LIH Class II 1994-03-10
K914479 MICROSENSOR INTRACRANIAL PRESSURE TRANSDUCER Codman & Shurtleff, Inc. GWM Class II 1994-03-07
K933233 CEEGRAPH, MODIFICATION Bio-Logic Systems Corp. GWQ Class II 1994-03-03
K932842 SPACELABS MEDICAL MODEL 90481 EEG MODULE Spacelabs Medical, Inc. GWQ Class II 1994-03-02
K925810 CORDIS POLYPROPYLENE BURR HOLE RESERVOIR Cordis Corp. JXG Class II 1994-03-02
K924876 TENS DEVICE FOR RELIEF OF CHRONIC PAIN, MODIFIED Graham-Field, Inc. GZT Class II 1994-03-01
K931768 INTERFERENTIAL CURRENT THERAPY UNIT Lumiscope Co., Inc. LIH Class II 1994-02-23
K934619 FLEXMATE Medical Devices, Inc. GZJ Class II 1994-02-23
K932854 EZ GRIP DISPOSABLE ELECTRODES Advanced Adhesives GZJ Class II 1994-02-22

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