meddevicedb.com FDA Device Reference

Review Panel

Neurology FDA 510(k) Clearances & Devices

Cleared Devices
6,130
Product Codes (page)
32
Latest Decision
1989-03-22

Clearances · page 52 of 62

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K885328 RS-10 TELEPHONIC POLYSOMNOGRAPHY RECEIVER Telediagnostic Systems, Inc. GYE Class II 1989-03-22
K890747 EMPI REUSEABLE PIN-STYLE TENS ELECTRODE Empi GXY Class II 1989-03-16
K890614 EMPI MULTIDAY TENS DISPOSABLE ELECTRODE Empi GXY Class II 1989-03-16
K890605 EMPI ISLAND TENS ELECTRODE Empi GXY Class II 1989-03-16
K890710 DISPOSABLE EEG/EKG ELECTRODE, CAT. #EEDS Somatics, Inc. GXY Class II 1989-03-14
K890705 MEDIMOD(TM), MODEL 8900 Medical Devices, Inc. GZJ Class II 1989-03-09
K884814 BIOTENS Trekk Intl. GXY Class II 1989-02-27
K885246 ADVANTAGE Clark Davis Medical Systems, Inc. GWF Class II 1989-02-27
K884071 AMPLAID EMG15 Amplus Corp. GWL Class II 1989-02-27
K884870 TECA/MEDELEC 'CONCEPT' P420 Teca, Inc. GWF Class II 1989-02-23
K890567 BITE BLOCK #59430 Medi-Source, Inc. JXL Class II 1989-02-17
K890216 MICROSURGICAL KERATOME Kinetic Medical Products GZX Class I 1989-02-16
K884833 ULTRA 2000 (T.E.N.S.) Maxima Intl., Inc. GZJ Class II 1989-02-13
K880744 ANESTY 10 Nihon Medix Co., Ltd. GZJ Class II 1989-02-09
K884851 BIOFEEDBACK DEVICE TG3, TG4 Moe HCC Class II 1989-02-03
K884848 BASIC BIOFEEDBACK,TMG4.1, SA1/2, EEG4/5, IR RECEIV Moe HCC Class II 1989-02-02
K884850 BIOFEEDBACK TMG1, 4, BIO1, PA1, 2, BA1/BA30 Moe HCC Class II 1989-02-02
K884853 BIOFEEDBACK EEG1/2, EEG ULTRA LOW NOISE, SYC1 Moe HCC Class II 1989-02-02
K884852 BIOFEEDBACK DEVICE EMG1, EMG ULTRA LOW NOISE OPTI. Moe HCC Class II 1989-02-02
K890231 SURGICAL TOWEL CLIPS Kinetic Medical Products HBR Class I 1989-01-27
K884948 MODEL 3587A RESUME EPIDURAL LEAD Medtronic Vascular GZB Class II 1989-01-17
K884663 IMPULSE EPIDURAL ELECTRODE Impulse Systems, Inc. JXE Class II 1989-01-17
K885033 MODEL 3487A PISCES EPIDURAL LEAD Medtronic Vascular GZB Class II 1989-01-17
K884135 DM100 (DISTAL MONITOR - 100) Bio.Logic, Inc. HCC Class II 1989-01-17
K883340 NEURAL MAGNETIC STIMULATOR, THE D190 Tracor Northern, Inc. GWF Class II 1988-12-29
K884537 AE-800PA EEG MODULE Nihon Kohden America, Inc. GWQ Class II 1988-12-29
K884347 MODIFIED DISPOSABLE COAXIAL BIPOLAR PEN Advanced Surgical Products, Inc. GXI Class II 1988-12-27
K884036 PMT MODEL 1110-5 PMT PERITONEAL CATHETER Pmt Corp. JXG Class II 1988-12-22
K883188 T.E.N.S. UNIT SIGMA & TX-3 Diamond Medical Equipment, Inc. GZJ Class II 1988-12-16
K883557 NEUROWAVE SYSTEM 2 Durden Enterprises, Inc. GWQ Class II 1988-12-16
K884348 MODIFIED JELTRODE(TM) ELECTRODES DEEMED Henley Intl. GXY Class II 1988-12-15
K884210 TX-7 (TENS) (IC-1107) Oms Medical Supplies, Inc. GZJ Class II 1988-12-12
K883947 ISO-100 ISOLATION AMPLIFIER Telediagnostic Systems, Inc. GYE Class II 1988-12-05
K883461 DAD 16S, DATA ACQUISTION DEVICE 16 CH. SERIES Biohm, Inc. GYE Class II 1988-11-30
K883780 XTREL, MODEL NUMBER 3425 Medtronic Vascular GZB Class II 1988-11-30
K883812 HP-1 (HEALTHPAX) Healthdirections, Inc. QJQ Class II 1988-11-28
K884294 NICOLET NYSTAR PLUS SYSTEM Nicolet Instrument Corp. GWN Class II 1988-11-23
K883597 MYODAC Thought Technology , Ltd. HCC Class II 1988-11-16
K883236 CEFAR DUAL Cefar Medical Products, Inc. GZJ Class II 1988-11-16
K882464 DTL MICROTOUCH EYE ELECTRODE Lectromedics, Inc. GXY Class II 1988-11-15
K883881 MODIFIED MODEL 2001 FIBER OPTICS CATHETER Metatech Corp. GWM Class II 1988-10-27
K882599 NICOLET BRAINLAB SYSTEM Nicolet Instrument Corp. GWK Class II 1988-10-19
K882053 NICOLET EPIDURAL SPINAL ELECTRODE Nicolet Instrument Corp. GYC Class II 1988-10-18
K881915 DANTEC MAGNETIC STIMULATOR Dantec Electronics, Inc. GWF Class II 1988-10-17
K884032 MORGAN TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR Morgan Associates, Inc. GZJ Class II 1988-10-13
K880924 INTER TRON 4000 Diversified Chiropractic Systems LIH Class II 1988-10-13
K883416 MOUTHPIECE BREATHING (PERFORMANCE MOUTHGUARD) Scott All-Sports, Inc. JXL Class II 1988-10-12
K883963 RANEY AND LEROY-RANEY SCALP CLIP New England Surgical Instrument Corp. HBO Class II 1988-10-07
K883869 DERMTRODE World Precision Instruments, Inc. GYA Class I 1988-09-30
K883607 PEEL-AWAY INTRODUCER FOR VENTRICULAR CATHETER Codman & Shurtleff, Inc. GYK Class I 1988-09-30
K882154 HEPAX (TENS) Avl Scientific Corp. GZJ Class II 1988-09-30
K882888 MULTIDAY, MODELS 8300 AND 8310 Medical Devices, Inc. GXY Class II 1988-09-30
K881177 MODEL MEB-5304 EVOKED POTENTIAL & ELECTRO. RECORD Nihon Kohden America, Inc. GWL Class II 1988-09-30
K882887 PROGEL(TM), MODELS 8630 AND 8635 Medical Devices, Inc. GXY Class II 1988-09-29
K882886 PROGEL (TM) DUAL ELECTRODE PAD, MODEL 8535 Medical Devices, Inc. GXY Class II 1988-09-29
K883149 TEN20 CONDUCTIVE Weaver & Co. GYB Class II 1988-09-28
K874818 TENSTAR Healthcheck Corp. GZJ Class II 1988-09-28
K882809 THYMAPAD Somatics, Inc. GXY Class II 1988-09-27
K881416 MYOTRAC Thought Technology , Ltd. HCC Class II 1988-09-26
K882631 EMPI MODEL 727,NMS Empi GZJ Class II 1988-09-22
K883518 EVENT MARKER & A SECOND PRESSURE TREND OUTPUT Metatech Corp. GWM Class II 1988-09-22
K875072 MODIFIED AMANA ELECTROTHERAPEUTIC SYSTEM Amana Medical Group GZJ Class II 1988-09-22
K880426 ELECTROSTIMULATOR MODEL 808 Cornell Enterprises Co., Inc. GZJ Class II 1988-09-19
K881616 PMT MANKIND LUMBAR-PERITONEAL SHUNT MODEL 1115-1 Progress Mankind Technology JXG Class II 1988-09-09
K882552 METATECH ROBINSON BOLT ACCESSORY Metatech Corp. GWM Class II 1988-09-08
K882422 DISPOSABLE ARACHNOID KNIFE Microbio-Medics, Inc. HAO Class I 1988-09-06
K881753 ALPHA-STIM 350 Electromedical Products, Inc. GZJ Class II 1988-08-30
K883115 PMT SUBARACHNOID SCREW, MODEL NO.1350-2 Pmt Corp. GWM Class II 1988-08-29
K882820 MEDIPAC II EC (TM), MODEL 7900 Medical Devices, Inc. GZJ Class II 1988-08-29
K883114 SPETZLER MANKIND VENTRICULOSTOMY EXTERNAL 1114-1 Pmt Corp. JXG Class II 1988-08-24
K882943 MEDA ONE-STEP Medical Electronic Assn. GZJ Class II 1988-08-19
K880773 THE VENUS SYSTEM Neuroscientific Corp. GWL Class II 1988-08-18
K882802 STORZ DISPOSABLE BIPOLAR PENCILS Storz Instrument Co. GXI Class II 1988-08-17
K882266 DIGITAL EMG MONITOR MYOTRON 120 Ats Co. HCC Class II 1988-08-15
K881708 INDICATENS 4X4 Acudata Software GZJ Class II 1988-08-11
K881132 LAITINEN'S TRIGEMINUS STEREOGUIDE Sandstrom Trade & Technology, Inc. HAW Class II 1988-08-09
K881131 THE LAITINEN STEREOTACTIC SYSTEM Sandstrom Trade & Technology, Inc. HAW Class II 1988-08-01
K880042 ACUTRON Davis Assoc. GZJ Class II 1988-08-01
K882286 EXPANSION COUPLER & MANUAL DRILL AS ACCESSORY SET Metatech Corp. GWM Class II 1988-07-18
K881749 STRAIGHT-LINE FINISH FOR IMPLANTABLE PULSE GENERA. Medtronic Vascular GXY Class II 1988-07-18
K875287 H-H FLUSHING RESERVOIR Holter-Hausner Intl. JXG Class II 1988-07-14
K881832 DS-200 AND DS-400 T.E.N.S. Delta Marketing, Inc. GZJ Class II 1988-07-01
K882072 ORTHOPAEDIC AND SPINAL RING CURRETTES Karlin Technology, Inc. JXH Class II 1988-06-17
K882062 MODEL BIOSTAR Targus Concepts HCC Class II 1988-06-17
K881871 SPARE MS 700 TENS ELECTRODE Lectec Corp. GXY Class II 1988-06-16
K881872 TENS ELECTRODE MODEL 238P Lectec Corp. GXY Class II 1988-06-16
K882071 CRANK FRAME RETRACTOR Karlin Technology, Inc. GZT Class II 1988-06-10
K881444 T.E.N.S. ELECTRODE NON-STERILE Tens Accessories, Inc. GXY Class II 1988-06-10
K881912 SANO CLIP APPLIERS & REMOVERS Downs Surgical , Ltd. HCI Class II 1988-06-06
K881911 NEW SIZES SUGITA CLIPS Downs Surgical , Ltd. HCI Class II 1988-06-06
K875205 TRI-FLOW CATHETER Neurodynamics, Inc. JXG Class II 1988-05-31
K881418 CRANIOTOME BLADE OR NEURO BLADE Nuell Air Equipment & Hospital Supplies, Inc. HBE Class II 1988-05-31
K880545 STIMWEAR GARMENTS, SIGNAL I AND SIGNAL II Stimwear GXY Class II 1988-05-31
K881265 RANEY CLIPS Zimmer, Inc. HBO Class II 1988-05-31
K881491 MODEL 3487A PISCES EPIDURAL LEAD Medtronic Vascular GZB Class II 1988-05-25
K874850 EPI-SCAN SELECTIVE TISSUE CONDUCTANCE METER Epi-Scan Corp. GZO Class II 1988-05-20
K881690 PORT-A-CATH PORTAL INTRODUCER FORCEPS Pharmacia Deltec, Inc. LKG Class II 1988-05-20
K881493 PORT-A-CATH IMPLANTABLE ACCESS SYSTEM - KIT CONF. Pharmacia Deltec, Inc. LKG Class II 1988-05-20
K880916 M444 EMG MONITOR Bio-Logic Devices HCC Class II 1988-05-11
K880914 T824 TEMPERATURE MONITOR Bio-Logic Devices HCC Class II 1988-05-11

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