meddevicedb.com FDA Device Reference

Review Panel

Neurology FDA 510(k) Clearances & Devices

Cleared Devices
6,130
Product Codes (page)
33
Latest Decision
1991-02-21

Clearances · page 50 of 62

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K905433 CODMAN DISPOSABLE SCALP CLIP APPLIER Codman & Shurtleff, Inc. HBO Class II 1991-02-21
K900723 ITC BUNJI COIL Interventional Therapeutics Corp. HCG Class II 1991-02-19
K903690 MEDTRONIC (R) MODEL 3625 SCREENER Medtronic Vascular GZB Class II 1991-02-14
K910226 DURAL DISSECTORS Acra Cut, Inc. HAO Class I 1991-02-12
K903497 FLEXCOMP DSP & PROCOMP Thought Technology , Ltd. HCC Class II 1991-02-12
K910225 BONE PAD REMOVER Acra Cut, Inc. HAO Class I 1991-02-12
K910199 MEDTRONIC MODEL 3487A PISCES-QUAD LEAD Medtronic Vascular GZB Class II 1991-02-11
K901797 THE WONDER BOX Micro Tronics Corp. GWL Class II 1991-02-07
K903731 SAPPHIRE SERIES 1P, 1L, 2L, AND 2ME Teca, Inc. GWF Class II 1991-02-04
K905407 MODEL 3487A PISCES-QUAD,3587A RESUME,3586 RESUME Medtronic Vascular GZB Class II 1991-02-01
K904409 MEDTRONIC(R) MODEL 3470 X-TREL(TM) RECEIVER Medtronic Vascular GZF Class II 1991-01-30
K902450 BODYLOG ENHANCED STRESS REDUCTION PACKAGE Bodylog, Inc. HCC Class II 1991-01-25
K905255 NEUROMED MODEL 1992 LS LAMITRODE LEAD Neuromed, Inc. GZB Class II 1991-01-25
K905445 ADSON-BECKMAN RETRACTOR, SPINAL A. Henniss GZT Class II 1991-01-25
K904222 VISTA GRAPH POLYSOMNOGRAPHY AMPLIFIER Telediagnostic Systems, Inc. GWL Class II 1991-01-18
K903828 SYNAPS (TM) Henley Intl. GZJ Class II 1991-01-18
K903814 NEUROMED TS8 TEST STIMULATOR Neuromed, Inc. GZB Class II 1991-01-16
K903128 STIMTRAC PC, CATALOG NO. 78-8510 Stimtech Products GZJ Class II 1991-01-02
K903844 OMNISHUNT SYSTEM FOR VENTRICULAR SHUNTING Cordis Corp. JXG Class II 1990-12-28
K905097 MICRO-AIRE MODEL NUMBER: MK-426 Micro Surgical Instruments Corp. HBE Class II 1990-12-21
K902822 MEDICAL DESIGNS, INC., SPECTRUM II TENS DEVICE Medical Design & Manufacturing Corp. GZJ Class II 1990-12-19
K903151 INTERVERTEBRAL DISC RONGEUR Von Zeppelin GmbH HAE Class II 1990-12-11
K902752 NEURITOR 2001 Imexco General , Ltd. GWQ Class II 1990-12-04
K896825 TRANSCUTANEOUS ELECTRONIC NERVE STIMULATOR Infrasonics Corp. GZJ Class II 1990-11-16
K903004 EE1114, 1118, 1121 ELECTRO-ENCEPHALOGRAPH Teca, Inc. GWQ Class II 1990-11-15
K902703 CRANIOTOME BLADE OR DRILL BIT A. Henniss HBE Class II 1990-11-13
K901337 HILAL EMBOLIZATION MICROCOIL(TM) Cook, Inc. HCG Class II 1990-11-13
K903017 MEGA-TENS DUAL CHANNEL T.E.N.S. Futuremed Div. of Future Impex Corp. GZJ Class II 1990-10-26
K901549 CNS SATELLITE 100, 200, 1000, 2000 ELECTROENCE. Cns, Inc. GWQ Class II 1990-10-24
K904120 ACCU-FLO* UNITIZED SHUNT Codman & Shurtleff, Inc. JXG Class II 1990-10-09
K896409 M(3):MICRO MUSCLE MONITOR Thought Technology , Ltd. HCC Class II 1990-10-09
K903085 SMS-712NA Toshiba America Medical Systems, In.C GXW Class II 1990-10-05
K903654 LISS CRANIAL STIMULATOR MODEL SBL202-B Medical Consultants Intl. , Ltd. QJQ Class II 1990-10-04
K900639 DYNATRON 350 EMG/BIOFEEDBACK ANALYZER Dynatronics Laser Corp. HCC Class II 1990-10-04
K904283 PS MEDICAL CRANIAL HAND DRILL Pudenz-Schulte Medical Research Corp. HBG Class II 1990-10-03
K896408 QUANTUM Stressmaster Systems, Inc. GZJ Class II 1990-09-20
K902544 SUNDT AVM MICRO CLIP Codman & Shurtleff, Inc. HCI Class II 1990-09-20
K902818 MULTIPLE NONPOWERED NEUROSURGICAL INSTRUMENT Ruggles Corp. HBG Class II 1990-09-20
K902921 RAYON NEUROLOGICAL SPONGE American Silk Sutures, Inc. HBA Class II 1990-09-18
K903664 MICRO-AIRE WIRE PASS AND CRANIOTOME DRILL Micro-Aire Surgical Instruments, Inc. HBE Class II 1990-09-13
K902976 MEDI MODEL SBL502-B (LISS BODY STIMULATOR) ZERO DC Medical Consultants Intl. , Ltd. GZL Class II 1990-09-07
K901393 MAINZ HEAD FIXATION BY PERNECZKY Zeppelin GmbH HBL Class II 1990-09-04
K900472 SKYTRON MODEL 860 AND 800 COMP. SURGITA NEURO EQUI Skytron, Div. the Kmw Group, Inc. HBN Class I 1990-09-04
K903554 NORTECH MODEL 87202204 ELECTRODE Medtronic Andover Medical, Inc. GXY Class II 1990-08-30
K901417 ELECTROSTIM MST Promatek Industries, Ltd. GZJ Class II 1990-08-28
K903402 GEOHESIVE (TM), MODEL NUMBERS 1022L, 1023L, 1026L Medi-Source, Inc. GXY Class II 1990-08-22
K903427 NORTECH MODEL 86901000 ELECTRODE Andover Medical, Inc. GXY Class II 1990-08-17
K901312 PERNECZKY ANEURYSM CLIP Von Zeppelin GmbH HCH Class II 1990-08-17
K901726 LUMISCOPE MICRO 100 Lumiscope Co., Inc. GZJ Class II 1990-08-14
K903401 SPECIAL RONGEUR Sur-Med Instruments, Inc. HAE Class II 1990-08-10
K902783 PS MEDICAL DELTA CSF-FLOW CONTROL VALVE Pudenz-Schulte Medical Research Corp. JXG Class II 1990-08-08
K894560 QSI 9000 Quantified Signal Imaging, Inc. GWF Class II 1990-08-08
K896787 TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION Saratoga Intl., Inc. GZJ Class II 1990-07-30
K901313 INSTRUMENTS FOR NEUROLOGICAL SURGERY Von Zeppelin GmbH HAE Class II 1990-07-23
K902257 CODMAN* EXTERNAL DRAINAGE SYSTEM II (EDS-II) Codman & Shurtleff, Inc. JXG Class II 1990-07-19
K902719 SPECT.E.N.S. REPOSTION.-E FOAM PIN TYPE TENS ELECT Labeltape Meditect, Inc. GXY Class II 1990-07-19
K902850 ZEPPELIN INSTRUMENTS Ruggles Corp. HAO Class I 1990-07-18
K901630 CHEMPAD(TM), ELECTROCONDUCTIVE MEDIA (882.1275) Henley Intl. GYB Class II 1990-07-16
K901670 GNOMOS STEREOTACTIC DEVICE Medical Equipment Development Co., Inc. HAW Class II 1990-07-03
K901721 MODIFIED TARGET THERAPEUTICS COILS Target Therapeutics HCG Class II 1990-07-03
K884823 TRANSPAC(R) II, DISPOSABLE TRANSDUCER Abbott Laboratories GWM Class II 1990-07-03
K902517 NEUROSURGICAL HEADFRAME ACCESSORIES Sims Surgical, Inc. GZT Class II 1990-07-03
K901499 NEUROMED OCTRODE MODEL MNR-88 W/98 ADAPTER NEURO. Neuromed, Inc. GZB Class II 1990-06-29
K901372 LAMINECTOMY RONGEUR Zeppelin GmbH HAE Class II 1990-06-28
K901563 MOUTHPIECE BREATHING Scott All-Sports, Inc. JXL Class II 1990-06-28
K901215 700 SERIES BIOMAGNETOMETER Biomagnetic Technologies, Inc. OLX Class II 1990-06-25
K900596 ACUDATA INDICATENS MODEL 5A Acudata Software GZJ Class II 1990-06-22
K900668 ACUDATA INDICATENS MODEL 5XS Acudata Software GZJ Class II 1990-06-22
K900482 SOFTWARE & HARDWARE ADDITION TO SENTINEL-4 EEG Axon Systems, Inc. GWF Class II 1990-06-20
K901809 LUMISCOPE ELECTRODES MODELS EL-08,11,15,06,21,25 Lumiscope Co., Inc. GXY Class II 1990-06-18
K902195 TBD TENS REUSABLE ELECTRODE Empi GXY Class II 1990-06-08
K900200 COOK STEREOTAXIC GUIDE Cook, Inc. HAW Class II 1990-05-31
K900759 POLY-OP (TM) Nu-Gyn-Tek, Inc. OCF Class II 1990-05-24
K894911 SENSORY NEEDLE ELECTRODE DNE 111-115,116-117,118 Dantec Electronics, Inc. GXZ Class II 1990-05-14
K901280 DISPOSIBLE EEG NEEDLE ELECTRODES Medicotest, Inc. GXZ Class II 1990-05-11
K900740 SPECIMEX DC Soredex Medical Systems GXZ Class II 1990-05-11
K900388 MODIFIED STERILIZATION OF DRILLS, BURRS, TREPHINES Midas Rex Pneumatic Tools, Inc. HBE Class II 1990-05-07
K894515 LISS CRANIAL STIMULATOR MODEL SBL201-M Medical Consultants Intl. , Ltd. QJQ Class II 1990-05-03
K901575 REUSABLE TENS PARAVERTEBRAL PAD #641 BACK ELECTROD Pioneering Technologies, Inc. GXY Class II 1990-05-02
K890061 MODEL 3586 RESUME LEAD Medtronic Vascular GZB Class II 1990-04-30
K896620 NEUROTENS Henley Intl. GZJ Class II 1990-04-26
K895635 MYOSYSTEM 1000 ELECTROMYOGRAPH Noraxon USA, Inc. HCC Class II 1990-04-19
K895633 MYOTRACE 10 BIOFEEDBACK DEVICE Noraxon USA, Inc. HCC Class II 1990-04-13
K900825 'POLYSTIM' Medical Science Products, Inc. GXY Class II 1990-04-10
K896226 LISS BODY STIMULATOR MODEL SBL501-M Medical Consultants Intl. , Ltd. GZJ Class II 1990-04-10
K900378 EMG OPTION FOR MICROSHEV 4000 Micro-Shev , Ltd. JXE Class II 1990-04-10
K895524 HYDROCEPHALUS SHUNT SYSTEM, LOW/MEDIUM/HIGH PRESS. Theramed, Inc. JXG Class II 1990-04-10
K900676 CSF-FLOW CONTROL VALVE, CYLINDRICAL & SHUNT KIT Pudenz-Schulte Medical Research Corp. JXG Class II 1990-04-03
K891993 COLLAGEN NEUROSPONGE Vitaphore Corp. HBA Class II 1990-03-23
K901103 MODIFIED ISLAND SNAP TENS DISPOSABLE ELECTRODE Empi GXY Class II 1990-03-23
K901102 MODIFIED ISLAND PIN TENS DISPOSABLE ELECTRODE Empi GXY Class II 1990-03-23
K896723 CLIP GUN WITH RANEY TYPE SCALP CLIPS Omni Medical Designs HBO Class II 1990-03-23
K896766 TD-28 DISPOSABLE ELECTRODE Med USA GXY Class II 1990-03-14
K900606 'CONDUCTOR' DISPOSABLE TENS ELECTRODE Medical Science Products, Inc. GXY Class II 1990-03-13
K900997 K-STERILE TENS ELECTRODES Katecho, Inc. GXY Class II 1990-03-13
K894629 NICOLET BEAM II SYSTEM Nicolet Instrument Corp. GWS Class I 1990-03-09
K896942 SPACELABS MODEL 90480 EEG MODULE Spacelabs, Inc. GWQ Class II 1990-03-08
K900656 SPEC T.E.N.S. PREWIRED REPOSITIONABLE TENS ELECT. Labeltape Meditect, Inc. GXY Class II 1990-03-01
K896834 MODEL BT-1 FOT BOLT INSTALLATION KIT Pearl Instruments Corp. GWM Class II 1990-02-23
K896948 ALPHA-STIM CS Electromedical Products, Inc. GZJ Class II 1990-02-23

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