meddevicedb.com FDA Device Reference

Review Panel

Neurology FDA 510(k) Clearances & Devices

Cleared Devices
6,130
Product Codes (page)
31
Latest Decision
1982-09-24

Clearances · page 59 of 62

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K822600 NEUROMEDICS ORIONS #660-01 Intermedics, Inc. GZJ Class II 1982-09-24
K822396 THE 3500 Tracor Northern, Inc. GWF Class II 1982-09-24
K822636 CLASS II DEVICE FOR I.C.P. MONITORING Philadelphia Medical Specialties GWM Class II 1982-09-14
K822428 SURGI-QUIP MICROSCOPE STAND Surgi-Quip Inc.U HBN Class I 1982-09-02
K822426 MCINTYRE MICROSCOPE STAND Surgi-Quip Inc.U HBN Class I 1982-09-02
K822177 AUDIOMETERS (VARIOUS MODELS) Kelleher Corp. GWJ Class II 1982-08-25
K822378 TENS ELECTRODE Franklin Sales & Mfg. Co. GXY Class II 1982-08-24
K822169 SURGICAL HEAD SUPPORT Kelleher Corp. HBM Class I 1982-08-20
K822266 NAGASHIMA KN-52 SACCADE & PURSUIT STIM Kelleher Corp. GWN Class II 1982-08-16
K822224 EMPI SINGLE USE Empi GXY Class II 1982-08-16
K822018 JACKSON BITE BLOCKS Kelleher Corp. JXL Class II 1982-08-03
K822012 BINOCULAR OPERATING MICROSCOPES & Kelleher Corp. HBN Class I 1982-07-30
K822048 H-H NERVE ROOT RETRACTOR Holter-Hausner Intl. HAO Class I 1982-07-22
K821571 TP440 ORTHOPROBE Grove Video Corp. GZJ Class II 1982-07-21
K821539 MEDICOTEST ELECTRODE PASTE Medicotest, Inc. GYB Class II 1982-07-02
K821250 METRACO EVOKED POTENTIAL SYSTEM Metraco, Inc. GWL Class II 1982-07-02
K820988 MEDTRONIC #1992-2 DUAL RATE TRANSMITTER Medtronic Vascular GZB Class II 1982-06-23
K821523 OMNI TENS Omni Intl., Inc. GZJ Class II 1982-06-16
K821107 EXOPHTHALMOMETER Medical Equipment Designs, Inc. HCS Class II 1982-06-14
K821363 TRANS-Q Chesapeake Medical Assoc. GZJ Class II 1982-05-28
K821357 MODIFIED NEURO SURGERY NIBBLING FORCEPS Downs Surgical , Ltd. HAO Class I 1982-05-14
K820653 OTE BIOMEDICA BERG FOURIER ANALYZER Del Mar Avionics OLT Class II 1982-05-07
K820908 TECA MODEL SENSOR ER 94 Teca, Inc. GWF Class II 1982-05-03
K820651 MODEL 860-1 VERI/PROBE Verite GZJ Class II 1982-04-29
K820326 BIGSTON TRANSCUTANEOUS NERVE STIMULAT Canadian Medical Products GZJ Class II 1982-04-29
K820991 KENZ-GELECT GEL PAD Suzuken Co., Ltd. GYB Class II 1982-04-26
K820779 OTE BIOMEDICAL #1296 - 16 CHAN. RECORD Del Mar Avionics GWQ Class II 1982-04-26
K820876 MODEL 3854 ELECTRODE Medtronic Vascular GXY Class II 1982-04-21
K820622 ELECTROSTIMULI AVERSION MACHINE Michael R. Kiss HCB Class II 1982-04-09
K820604 OTE BIOMEDICA NEUROGRAPH 9 Del Mar Avionics GWQ Class II 1982-03-23
K820678 SYSTEM 10 Biostim, Inc. GZJ Class II 1982-03-23
K820605 OTE BIOMEDICA NEUROGRAPH 18 Del Mar Avionics GWQ Class II 1982-03-23
K820603 OTE BIOMEDICA NEUROGRAPH 14 Del Mar Avionics GWQ Class II 1982-03-23
K813601 E.W.L. P-TENS MODEL(TENS Electronic Waveform Laboratory, Inc. GZJ Class II 1982-03-19
K820496 TENS MODEL 8201 Medical Scientific Instruments GZJ Class II 1982-03-15
K820414 UNIVERSAL TESTING & ANALYSIS SYSTEMS Lkc Technologies, Inc. GWF Class II 1982-03-04
K820312 H-H RICKHAM TYPE RESERVOIR Holter-Hausner Intl. JXG Class II 1982-03-01
K820311 H-H BURR HOLE CATHETER SUPPORT Holter-Hausner Intl. JXG Class II 1982-02-24
K813569 EMOTENS Electro Medica Office GZJ Class II 1982-02-24
K812612 TNS MK I STIMULATOR Edu Kit , Ltd. GZJ Class II 1982-02-18
K820247 EXTERNAL VENTRICULAR DRAINAGE SYS. American Heyer Schulte JXG Class II 1982-02-18
K813283 10D (TENS DEVICE) Staodynamics, Inc. GZJ Class II 1982-02-10
K820031 CADWELL 5200 Cadwell Laboratories, Inc. JXE Class II 1982-02-04
K820066 ELECTROENCEPHALOGRAPHS EEG-5208,5210 Nihon Kohden America, Inc. GWQ Class II 1982-02-04
K820087 CODMAN * REUSABLE PERFORATOR Codman & Shurtleff, Inc. HBF Class II 1982-02-04
K820040 SC-IT IMPEDANCE TESTER Cadwell Laboratories, Inc. GYA Class I 1982-01-28
K820151 PHILLY INFANT BOLT Philadelphia Medical Specialties GWN Class II 1982-01-28
K820082 POST-OP ELECTRODE (TENS ELECTRODE) Consolidated Medical Equipment, Inc. GXY Class II 1982-01-28
K813515 VERI/DFS TM #817 Verite GZI Class II 1982-01-19
K813501 TRANSCUTANEOUS ELEC. NERVE STIMULATOR Empi GZJ Class II 1981-12-29
K813440 PHILLY BOLT Philadelphia Medical Specialties GWM Class II 1981-12-18
K813009 TECA VISUAL/AUDIO STIMULATOR MODEL CS-2 Teca, Inc. GWJ Class II 1981-12-14
K813304 CONPHAR, TUNING FORKS Conphar, Inc. GWX Class I 1981-12-10
K812744 LEVY BIOTAC #LX001 BIOPSY PROBE HOLDER Progress Mankind Technology HAW Class II 1981-12-03
K813100 BIO-STIMULATOR, MODEL 400 Med-Western Electronics, Inc. GZJ Class II 1981-11-27
K813010 EEG TELEPHONE TRANSMITTER, MODEL #T-7 Pharmaquest Corp. GYE Class II 1981-11-16
K812952 RION AUDIOMETER AA-68 Rion Acoustic Instruments, Inc. GWO Class II 1981-11-06
K812951 RION AUDIOMETER AA-67 Rion Acoustic Instruments, Inc. GWO Class II 1981-11-06
K812432 HEALTH-UP Wfx Industries, Inc. GZJ Class II 1981-11-06
K812436 450/800 DRILL Black & Decker(Tm) HBC Class II 1981-11-02
K812263 KENZ-GELECT Suzuken Co., Ltd. GYB Class II 1981-11-02
K812704 NEUROMED SELECTRA #7720 Medtronic Vascular GZJ Class II 1981-10-19
K812155 MEDTRONIC DUAL CHANNEL SPINAL CORD STIM Medtronic Vascular GZB Class II 1981-10-08
K812619 ISOLATED VOLTAGE/FREQUENCY CONVERTER Bio-Feedback Systems, Inc. HCC Class II 1981-10-08
K811821 CAROTID ARTERY CLAMP & TOOLS New England Surgical Instrument Corp. HCE Class II 1981-09-24
K812418 MEDTRONIC #3798 ELECTRODE Medtronic Vascular GXY Class II 1981-09-16
K812299 ELECTRO-SNAP Rodel Products Corp. GXY Class II 1981-09-11
K812284 ZEE ELECTRODE-GEL Zee Medical Products Co., Inc. GYB Class II 1981-09-08
K811848 MODEL SIX BEAM SYSTEM Braintech, Inc. GWF Class II 1981-09-08
K812179 LIFE-TECH #1753 BIOFEEDBACK TRAINER Life-Tech Instruments, Inc. HCC Class II 1981-08-25
K812180 LIFE-TECH #5102 VISULAB Life-Tech Instruments, Inc. GWN Class II 1981-08-21
K812061 MODEL S10VS VISUAL STIMULATOR Grass Instrument Co. GWE Class II 1981-08-20
K812138 TENS DEVICE Western Advanced Technology, Inc. GZJ Class II 1981-08-20
K811499 TENSMAX Anritsu America Co. GZJ Class II 1981-08-20
K812154 MEDTRONIC #3484 PISCES EPIDURAL LEAD Medtronic Vascular GZB Class II 1981-08-20
K812036 NEUROGAR III Inter Med Industries, Inc. GZJ Class II 1981-08-07
K811351 VERI-FIER Verite GZJ Class II 1981-07-30
K811939 VITATRON 88 Vitatronics GZJ Class II 1981-07-23
K811345 INSIGHT Staodynamics, Inc. GZJ Class II 1981-07-10
K811095 TRANSCUTANEOUS ELECTRICAL NERVE Acutec Corporation, Inc. GZJ Class II 1981-07-01
K811655 MYELOSTAT DORSAL CORD STIMULATOR Medtronic Vascular GZB Class II 1981-07-01
K811288 SPETZLER LUMBAR-PERITONEAL SYSTEM American Heyer Schulte JXG Class II 1981-06-26
K810841 MEDAID C.V.I., Inc. GZJ Class II 1981-06-12
K811452 BROWN-ROBERTS-WELLS STEREOTAXIC SYTEM Trent Wells, Inc. HAW Class II 1981-06-02
K811224 MINISTIM Medical Design & Manufacturing Corp. GZJ Class II 1981-06-02
K811012 TENS-O-MATIC O-Matic, Inc. GZJ Class II 1981-06-01
K810880 AR-1 PHYSIOLOGICAL PRODESSOR Atlas Researches , Ltd. HCC Class II 1981-05-27
K810882 ASR-3520 SKIN RESPONSE MONITOR;ASR-3520A Atlas Researches , Ltd. HCC Class II 1981-05-27
K810881 EMG 3510/EMG 3510D MYOFEEDBACK MONITORS Atlas Researches , Ltd. HCC Class II 1981-05-27
K810332 SC/TEMP 300 Thought Technology , Ltd. HCC Class II 1981-05-18
K811093 BRAEGEN EEG TRANSMITTER/RECEIVER SYS Electro-Bio-Medical Services, Inc. GYE Class II 1981-05-05
K810473 MK6 ERA SYSTEM Amplaid USA, Inc. GWJ Class II 1981-04-29
K810482 SOMATOSENSORY STIMULATOR Amplaid USA, Inc. GWF Class II 1981-04-29
K810182 PROGRAMMABLE SPINAL CORAL STIM. SYSTEM Electronic Diagnostics, Inc. GZB Class II 1981-04-03
K810138 SYNAP-I INFANT SENSORY ASSESSMENT UNIT Infant Hearing Assessment Foundation GWJ Class II 1981-04-03
K810193 TRIPPI-WELLS DUAL PURPOSE UNIVERSAL TONG Ace Orthopedic Manufacturing Co. HAX Class II 1981-03-20
K810206 DUAL TYPE ELECTRODE Professional Instruments Co. GXY Class II 1981-03-20
K810560 TN-3000 EVOKED RESPONSE SYSTEM Tracor Northern, Inc. GWF Class II 1981-03-17
K810539 MODEL S10CTCM AUDITORY STIMULATOR Grass Instrument Co. GWJ Class II 1981-03-17
K810359 ELECTROENCEPHALOMYOGRAPH Thoracel Research Labs. OLT Class II 1981-03-13

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