meddevicedb.com FDA Device Reference

Review Panel

Neurology FDA 510(k) Clearances & Devices

Cleared Devices
6,130
Product Codes (page)
40
Latest Decision
1988-05-11

Clearances · page 53 of 62

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K880913 M424 EMG MONITOR Bio-Logic Devices HCC Class II 1988-05-11
K880601 WIRE PASS DRILL BITS Nuell Air Equipment & Hospital Supplies, Inc. HBE Class II 1988-05-06
K881343 DURADERM BUTTERFLY Sentry Medical Products, Inc. GXY Class II 1988-05-04
K881183 VENTRICULAR BOLT PRESSURE MONITORING KIT #110-4H Camino Laboratories, Inc. GWM Class II 1988-05-04
K881704 EASY TENS American Imex GZJ Class II 1988-05-04
K880088 CADWELL EXCEL Cadwell Laboratories, Inc. GWF Class II 1988-05-04
K880492 INTERCEPT T.E.N.S. DEVICE Medical Design & Manufacturing Corp. GZJ Class II 1988-04-18
K881114 EMPI MODEL 989, TENS Empi GZJ Class II 1988-04-15
K880925 DISPOSABLE WET FIELD ERASER Advanced Surgical Products, Inc. GXI Class II 1988-04-13
K880951 DISPOSABLE COAXIAL BIPOLAR PEN P/N 00150 Advanced Surgical Products, Inc. GXI Class II 1988-04-13
K870384 ENDOMED 433 Henley Intl. LIH Class II 1988-04-13
K881424 PREMIER 10S (TENS) American Imex GZJ Class II 1988-04-11
K880980 SCHULDT* PC* - DUAL CHANNEL TENS Schuldt Laboratories, Inc. GZJ Class II 1988-04-11
K880751 ULTIMA XS (TENS) American Imex GZJ Class II 1988-04-06
K880593 TECA/MEDELEC MISTRAL Teca, Inc. GWE Class II 1988-04-06
K881160 CRANK FRAME RETRACTOR T. Korossurgical Instruments Corp. GZT Class II 1988-04-06
K880154 METATECH INTRACRANIAL PRESSURE MONITORING SYSTEM Metatech Corp. GWM Class II 1988-03-28
K874136 PHOTIC STIMULATOR MODELS 580-PSCOMP,PSCEEG,PSSTAL Bio-Logic Systems Corp. GWE Class II 1988-03-25
K873834 INET MODEL BIOVISION Inet Corp. HCC Class II 1988-03-24
K874829 MEDCO MEMORY RETRACTOR SYSTEM Medical Equipment Development Co., Inc. GZT Class II 1988-03-24
K880452 LUMISCOPE TENS MODEL 2000T OR APCC 3001 OR PAIN RE Lumiscope Co., Inc. GZJ Class II 1988-03-24
K874193 MICROSHEV MODEL 2000 Micro-Shev , Ltd. GWJ Class II 1988-03-21
K880293 THE STORZ BIPOLAR PENCIL AND CORD Storz Instrument Co. GXI Class II 1988-03-17
K874693 OBT STEREOTACTIC SYSTEM Tipal Instruments , Ltd. HAW Class II 1988-03-11
K880649 TENS ELECTRODE SNAP TYPE, DISPOSA., SELF-ADHERING Labeltape Meditect, Inc. GXY Class II 1988-03-04
K874833 ARC ADAPTER ASSEMBLY Medical Equipment Development Co., Inc. HAW Class II 1988-03-03
K880402 CODMAN SURGICAL PATTIE Codman & Shurtleff, Inc. HBA Class II 1988-03-02
K874733 GUARDIAN, EEG BRAIN MONITORING SYSTEM Tracor Northern, Inc. OLT Class II 1988-02-29
K875308 PROFESSIONAL SERIES BIOFEEDBACK DEVICES MODEL 421 Self Regulation Systems, Inc. HCC Class II 1988-02-26
K872877 TARGET PROGRAM & EPSON HX-20 COMPUTER Walter Lorenz Surgical, Inc. HAW Class II 1988-02-12
K874498 CSF-VENTRICULOSTOMY RESERVOIR Pudenz-Schulte Medical Research Corp. LKG Class II 1988-02-11
K880278 MALLEABLE PTFE COATED BRAIN SPATULAE Downs Surgical , Ltd. HAO Class I 1988-02-11
K874468 P-S MEDICAL VENTRICULAR ACCESS PORT Pudenz-Schulte Medical Research Corp. LKG Class II 1988-02-11
K873693 LEVTECH COMPOSITE TRACTION TONGS Levtech, Inc. HAX Class II 1988-02-05
K874298 MALCOLM-RAND MICRONEUROSURGICAL CRANIO-XRAY FRAME Engineered Orthopedic Technologies, Inc. HBL Class II 1988-02-04
K874962 FORCEPS CLIPRACK VENTRICULAR CANNULA SAWS SPATULAS Solway, Inc. HAO Class I 1988-02-02
K870815 KONTRON E.E.G. MONITOR, SUPERMON MODULE 7265 Kontron Instruments, Inc. GWQ Class II 1988-02-01
K873566 ELECTROSTIM I.F. Promatek Industries, Ltd. LIH Class II 1988-02-01
K874469 TRANSCUTANEOUS ELECTRIC NERVE STIMULATION (TENS) Axelgaard Mfg. Co., Ltd. GXY Class II 1988-01-28
K875224 HUDSON CRANINAL BURRS Tri-Med, Inc. HBE Class II 1988-01-28
K875018 GHAJAR GUIDE TWIST DRILL Neurodynamics, Inc. HBG Class II 1988-01-28
K874956 SELF-RETAINING RETRACTOR FOR NEUROSURGERY Solway, Inc. GZT Class II 1988-01-28
K875284 MEDTRONIC SNAP EASE MODEL 7795 CUTANEOUS ELECTRODE Medtronic Vascular GXY Class II 1988-01-28
K875043 RONGEUR (NEUROSURGICAL INSTRUMENTS) Solway, Inc. HAE Class II 1988-01-22
K874119 INTERFERENTIAL CURRENT UNIT Compustim Electronics LIH Class II 1988-01-22
K874735 DANTEC 13L35/36/37 STIM. AND RECORDING ELECTRODE Dantec Electronics, Inc. GXY Class II 1988-01-22
K872704 AMASTIM 2000 Amatech International, Inc. GZJ Class II 1988-01-22
K875019 GHAJAR GUIDE SYSTEM FOR THE PERFORATOR Neurodynamics, Inc. HBF Class II 1988-01-22
K874508 H-H EXTERNAL VENTRICULAR DRAINAGE COLLECTION BAG Holter-Hausner Intl. JXG Class II 1988-01-19
K874796 MODEL EEG 4400 WITH OPTIONAL ACCESSORIES Nihon Kohden America, Inc. GWQ Class II 1988-01-19
K874966 TUNING FORKS Solway, Inc. GWX Class I 1988-01-04
K874952 MANUAL CRANIAL DRILL, BURR, TREPHINE & ACCESSORIES Solway, Inc. HBG Class II 1987-12-30
K873920 BR-2 BIOREST Biorest, Inc. QJQ Class II 1987-12-29
K874630 RANGE OF TITANIUM NEUROSURGERY INSTRUMENTS Downs Surgical , Ltd. HAO Class I 1987-12-23
K873190 MEC-I-TRON, MODEL P-1 Meyer Equipment Company, Inc. GZJ Class II 1987-12-18
K873771 HEYER-SCHULTE(R) ONE PIECE SHUNT VENT. CATH. INTRO American V. Mueller GYK Class I 1987-12-18
K873933 RANGE OF NEUROSURGICAL INSTRUMENTS IN TITANIUM Downs Surgical , Ltd. GZX Class I 1987-12-17
K873692 RAYLOR(TM) DRILL STOP Cedar Surgical, Inc. HBE Class II 1987-12-17
K873418 BODYLOG STRESS REDUCTION PACKAGE Bodylog, Inc. HCC Class II 1987-12-17
K873934 RANGE OF CROCODILE ACTION INSTRUMENTS Downs Surgical , Ltd. GZX Class I 1987-12-17
K874085 REBUILDER(TM) Micromed, Inc. GZJ Class II 1987-12-11
K874257 S-10 TELEPHONIC POLYSOMNOGRAPH Telediagnostic Systems, Inc. GYE Class II 1987-12-11
K873298 ELEC-TIP Etymotic Research GXY Class II 1987-11-24
K874333 TX-2(TENS) Oms Medico, Inc. GZJ Class II 1987-11-20
K874550 TX-4(TENS) (SIGMA TENS) Oms Medico, Inc. GZJ Class II 1987-11-20
K872931 TECA/MEDELEC TTT THERMAL THRESHOLD TESTER Teca, Inc. LLN Class I 1987-11-16
K874300 AESTHESIOMETER Orthopedic Systems, Inc. GWI Class I 1987-11-06
K873689 CRANIOPLASTIC, ACRYLIC CRANIOPLASTY MATERIAL Dentsply Intl. GXP Class II 1987-10-26
K873357 ELECTROBLOC TRANS. ELECTRICAL NERVE BLOCK GENERA. Th Charters, Inc. GZJ Class II 1987-10-26
K873688 ANEUROPLASTIC, ACRYLIC ANEURYOMORRHAPLY MATERIAL Dentsply Intl. JXH Class II 1987-10-26
K873535 NICOLET EXPERT SLEEP/WAKE ANALYSIS SYSTEM Nicolet Biomedical Instruments GWQ Class II 1987-10-26
K870028 SMK SLUYTER-MEHTA CANNULAE, RF POLE, POLE,FLEXIBLE Radionics, Inc. GXI Class II 1987-10-26
K874075 PT-100-30 SOMATOSENSORY STIMULATING ELECTRODE Weaver & Co. GXY Class II 1987-10-20
K871931 ISTAT SOFTWARE Neuroscience, Inc. GWS Class I 1987-10-13
K873420 GLOBALCARE(TENS) Oms Medico, Inc. GZJ Class II 1987-10-08
K871990 MODEL MPA MULTI PARAMETER ANALYSIS MONITORING SYS. Oxford Medilog, Inc. OLZ Class II 1987-10-07
K872290 BIO-LOGIC BANKER Bio-Logic Systems Corp. GWK Class II 1987-10-06
K870567 EVOPORT 300 Dantec Electronics, Inc. GWF Class II 1987-10-06
K873675 MODIFIED #3587 RESUME SE-4/#3487 PISCES-QUAD Medtronic Vascular GZB Class II 1987-10-06
K871964 SIEGEN NEUROSCOPE SEEG FOR EVOKED RESPONSE STIMU. Siegen Corp. GWF Class II 1987-10-01
K870794 MEM-4104 EVOKED RESPONSE/ELECTROMYOGRAPHY RECORDER Nihon Kohden America, Inc. GWL Class II 1987-09-30
K873608 TENS LEAD Desco Industries, Inc. GZI Class II 1987-09-30
K873691 CEDAR(TM) RETRACTOR RING Cedar Surgical, Inc. GZT Class II 1987-09-28
K872976 TENS PALS PLUS Axelgaard Mfg. Co., Ltd. GXY Class II 1987-09-22
K873247 CSF-FLOW CONTROL VALVE, ULTRA SMALL Pudenz-Schulte Medical Research Corp. JXG Class II 1987-09-18
K873484 120Z(TENS) Oms Medico, Inc. GZJ Class II 1987-09-16
K872106 DANTEC COUNTERPOINT Dantec Electronics, Inc. GWF Class II 1987-09-10
K863136 HIGH PROFILE NEEDLE ELECTRODE (N-SPYRAL HP) Neurotechnics, Inc. GXZ Class II 1987-09-04
K863135 LOW PROFILE NEEDLE ELECTRODE (N-SPYRAL LP) Neurotechnics, Inc. GXZ Class II 1987-09-04
K872725 MODEL 100 VISUAL EVOKED RESPONSE RECORDING SYSTEM Eyetronics, Inc. GWE Class II 1987-08-14
K872250 LECTEC STIMULATING ELECTRODE Lectec Corp. GXY Class II 1987-08-07
K872657 ULTRAPAC II SX PLUS (TM) Medical Devices, Inc. GZJ Class II 1987-08-04
K870568 BIO-PROMPT(TM) Physical Health Devices, Inc. HCC Class II 1987-08-04
K872495 BIOCOMP 2001 BIOFEEDBACK DEVICE Biofeedback Research Institute, Inc. HCC Class II 1987-08-04
K871338 NOVAMETRIX MODEL 200 MAGSTIM Novametrix Medical Systems, Inc. GWF Class II 1987-08-04
K872398 T.E.N.S. DEVICE MODEL SPL 2000 Spartan Laboratories, Inc. GZJ Class II 1987-07-29
K872399 T.E.N.S. DEVICE MODEL SPL 2000S Spartan Laboratories, Inc. GZJ Class II 1987-07-27
K871466 VESTIBULAR AUTOROTATION TEST Western Systems Research, Inc. GWN Class II 1987-07-24
K872574 TENSAGAIN Ferris Mfg. Corp. GXY Class II 1987-07-23
K872492 ALTERNATE SUPPLIERS FOR TENS ELECTRODE Franklin Sales & Mfg. Co. GXY Class II 1987-07-22

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