Review Panel
Neurology FDA 510(k) Clearances & Devices
- Cleared Devices
- 6,130
- Product Codes (page)
- 34
- Latest Decision
- 2009-09-29
Clearances · page 27 of 62
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K083378 | SYNERGY | Innerspace, Inc. | GWM | Class II | 2009-09-29 |
| K091998 | ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-HIP | Mako Surgical Corp. | OLO | Class II | 2009-09-28 |
| K091411 | KNEEALIGN SYSTEM | Orthalign, Inc. | OLO | Class II | 2009-09-25 |
| K083597 | SONOWAND INVITE | Sonowand AS | HAW | Class II | 2009-09-25 |
| K092562 | MICROTARGETING STAR DRIVE SYSTEM, COMPONENTS | FHC, Inc. | HAW | Class II | 2009-09-18 |
| K092497 | SMITH & NEPHEW PIGALILEO SCREW TARGETING SYSTEM, VERSION 1.1 | Smith & Nephew, Inc. | OLO | Class II | 2009-09-11 |
| K091921 | CODMAN ANEURYSM CLIPS, CODMAN AVM MICRO CLIP SYSTEM, CODMAN SLIM-LINE GRAFT, REINFORCING, MINI ANEURYSM CLIP | Codman & Shurtleff, Inc. | HCH | Class II | 2009-09-08 |
| K092373 | ICS CHARTR EP 200 | Gn Otometrics | GWJ | Class II | 2009-09-03 |
| K091312 | PS MEDICAL STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM | Medtronic Neurosurgery | JXG | Class II | 2009-09-02 |
| K091439 | HEAD FIXATION ARC AND TABLE BASE | Surgivision, Inc. | HBL | Class II | 2009-08-25 |
| K083250 | NEUROMED ELECTROANALGESIC DELIVERY SYSTEMS | Aa Neuromed Corp. | GZJ | Class II | 2009-08-18 |
| K083758 | SENSORY NERVE ELECTRODES-TWO FINGER RINGS, STIMULATOR PROBE ELECTRODES-FACIAL, MONO, BI- & TRIPOLAR NERVE STIMULATORS | The Electrode Store, Inc. | GXY | Class II | 2009-08-14 |
| K090342 | POLARIS PRESSURE ADJUSTABLE VALVE, MODELS SPV, SPVA, SPVB, SPV-140, SPV-300, SPV-400 | Sophysa SA | JXG | Class II | 2009-08-11 |
| K082886 | ZOOM-100DC | Brainscope Company, Inc. | OLT | Class II | 2009-08-10 |
| K083603 | I-PORTAL 4D VIDEO OCULOGRAPHY EYE TRACKING SYSTEM (VOG), I-PORTAL VIDEO NYSTAGMOGRAPHY SYSTEM (VNG), I-PORTAL NEURO OTOL | Neuro Kinetics | GWN | Class II | 2009-08-06 |
| K090240 | MONTERIS MEDICAL UFO | Monteris Medical, | HAW | Class II | 2009-08-06 |
| K090750 | RT300-SL, MODEL FA100052; RT300-SLSA, MODEL FA104581 | Restorative Therapies, Inc. | GZI | Class II | 2009-08-05 |
| K083302 | LIFECARE ELECTRODES | Everyway Medical Instruments Co.,Ltd | GXY | Class II | 2009-08-03 |
| K091993 | RAPID PROGRAMMER, VERSION 3.3.0 | Advanced Neuromodulation Systems, Inc. (Ans Inc.) | GZB | Class II | 2009-07-31 |
| K091236 | MANTRA COMBO, MODEL MECS 320 | Mantra Intl. (Hk) , Ltd. | GZJ | Class II | 2009-07-30 |
| K090733 | PMT HALO SYSTEM | Pmt Corp. | HAX | Class II | 2009-07-28 |
| K091163 | PG471W , PG471/50W, PG474W, PG477W, PG479/32W, PG479/50W, PG479/75W FIAB DISPOSABLE ELECTRODES WITH CABLE FOR ELECTRO-ST | Fiab Spa | GXY | Class II | 2009-07-22 |
| K090587 | STARLIGHT | Orthomerica Products, Inc. | OAN | Class II | 2009-07-17 |
| K090955 | SMITH & NEPHEW RF CANNULATE | Smith & Nephew, Inc. | GXI | Class II | 2009-07-16 |
| K090579 | SMARTSCREENER-PLUS2 | Intelligent Hearing Systems | GWJ | Class II | 2009-07-07 |
| K091854 | BIS CLICK SENSOR/CABLE | Aspect Medical Systems, Inc. | GXY | Class II | 2009-07-02 |
| K082629 | S12X WITH ESAX OPTION | Chatten Associates, Inc. | GYC | Class II | 2009-07-01 |
| K091641 | HYDROCOIL EMBOLIC SYSTEM (HYDROSOFT) AND MICROPLEX COIL SYSTEM (HYPERSOFT) | MicroVention, Inc. | HCG | Class II | 2009-06-30 |
| K083756 | GUARDIAN 150 ELECTRODE | Selectivemed Components, Inc. | GXY | Class II | 2009-06-26 |
| K091317 | LUMBOFIX CONDUCTIVE GARMENT, MODEL 420 BACK | Bio-Medical Research, Ltd. | GZJ | Class II | 2009-06-25 |
| K090198 | JIAJIAN SELF-ADHESIVE ELECTRODE | Wuxi Jiajian Medical Instrument Co., Ltd. | GXY | Class II | 2009-06-23 |
| K090375 | ORTHOPILOT NEXT GENERATION-UKA SOFTWARE, MODEL FS210 | Aesculap Implant System, Inc. | OLO | Class II | 2009-06-23 |
| K090891 | MICROPLEX COIL SYSTEM-COSMOS | MicroVention, Inc. | HCG | Class II | 2009-06-22 |
| K083644 | MAKO SURGICAL TACTILE GUIDANCE SYSTEM-HIP | Mako Surgical Corp. | OLO | Class II | 2009-06-19 |
| K090298 | NUVASIVE NEURO VISION SYSTEM | Nuvasive, Inc. | GWF | Class II | 2009-06-08 |
| K090951 | RS- LB LOW BACK CONDUCTIVE GARMENT, MODEL RS-LBM, RS-LBL, RS-FBG FULL BACK CONDUCTIVE GARMENT , MODEL RS-FBG | Rs Medical | GXY | Class II | 2009-06-05 |
| K090922 | EMPI ACTIVE TRANSCUTANEOUS NERVE STIMULATOR | Empi | GZJ | Class II | 2009-06-05 |
| K091346 | CODMAN HAKIM MICRO II VALVE | Codman & Shurtleff, Inc. | JXG | Class II | 2009-06-02 |
| K090907 | PENTA LEAD KITS, MODELS: 3227-3234 | Advanced Neuromodulation Systems | GZB | Class II | 2009-06-02 |
| K090052 | CRANIAL ELECTRICAL NERVE STIMULATOR, MODEL FM 10/C | Johari Digital Healthcare , Ltd. | QJQ | Class II | 2009-05-29 |
| K090957 | BLACKROCK NEUROPORT BIOPOTENTIAL SIGNAL PROCESSING SYSTEM | I2s Micro Implantable Systems, LLC | GWL | Class II | 2009-05-28 |
| K090420 | SMITH & NEPHEW PIGALILEO SCREW TARGETING SYSTEM V 1.0 | Smith & Nephew, Inc. | OLO | Class II | 2009-05-27 |
| K083322 | NEUROMETRIX BIOAMPLIFIER | Neurometrix, Inc. | GWL | Class II | 2009-05-27 |
| K083441 | FREEDOM STIM 100 AND 200 ELECTRODE AND LEADWIRE EXTENSION | Motion Medical Products, LLC | GXY | Class II | 2009-05-22 |
| K081591 | NEUCODIA | Verisci Corporation | GWE | Class II | 2009-05-15 |
| K082474 | PMT SUBDURAL CORTICAL ELECTRODES | Pmt Corp. | GYC | Class II | 2009-05-08 |
| K082060 | CRANIAL IMAGE GUIDED SURGERY SYSTEM | Brainlab AG | HAW | Class II | 2009-05-08 |
| K090717 | FLEX-TENS | Emsi | GZJ | Class II | 2009-05-08 |
| K083822 | LASER TOUCHONE | Laser Health Technologies, LLC | GZJ | Class II | 2009-05-06 |
| K090042 | PAINMASTER MCT PATCH | Newmark, Inc. | NUH | Class II | 2009-05-06 |
| K081640 | GIMMI ANEURYSM CLIPS AND APPLYING FORCEPS | Gimmi GmbH | HCH | Class II | 2009-05-06 |
| K080355 | LEKSELL STEREOTACTIC SYSTEM WITH REUSABLE FIXATION SCREWS | Elekta Instrument AB | HAW | Class II | 2009-05-01 |
| K083112 | PRIMADO | Nakanishi, Inc. | HBC | Class II | 2009-04-29 |
| K090695 | DINKLER SURGICAL SKULL CLAMP, MODEL 0308 | Dinkler Surgical Devices, Inc. | HBL | Class II | 2009-04-23 |
| K083350 | TENS/NMES/FES STIMULATING ELECTRODE | Covidien LP | GXY | Class II | 2009-04-21 |
| K090506 | MAYFIELD INFINITY XR2 SKULL CLAMP, MODEL A-2114 | Integra LifeSciences Corporation | HBL | Class II | 2009-04-20 |
| K090357 | HYDROFRAME (HES) | MicroVention, Inc. | HCG | Class II | 2009-04-10 |
| K082065 | WELL LIFE SELF ADHESIVE ELECTRODE / MODELS: CM, FA, PU AND SP | Well-Life Healthcare Limited | GXY | Class II | 2009-04-10 |
| K083483 | BRAINLAB HIP UNLIMITED, CI HIP UNLIMITED | Brainlab AG | OLO | Class II | 2009-04-08 |
| K083310 | SPINE & TRAUMA ICT | Brainlab AG | OLO | Class II | 2009-04-01 |
| K090112 | MIDAS REX MR7 PNEUMATIC HIGH SPEED SYSTEM, MODELS PM700, PM710, PC700, PC710, PC720, PA700 | Medtronic Powered Surgical Solutions | HBB | Class II | 2009-03-26 |
| K081835 | ACTICARE IC AND TSE | Bioinduction Limited | GZJ | Class II | 2009-03-19 |
| K090272 | SPETZLER SCALP RETRACTOR CLAMPS (VARIOUS STYLES AND SIZES) | Cardinal Health, Inc. | GZT | Class II | 2009-03-18 |
| K090168 | AZUR DETACTABLE 18, MODELS 45-480305, 45-480310, 45-480405, 44-480415 | MicroVention, Inc. | HCG | Class II | 2009-03-12 |
| K090313 | PIGALILEO TKR BASE V2.3 AND CAS V4.1 | Smith & Nephew, Inc. | OLO | Class II | 2009-03-11 |
| K082190 | BAXOLVE XP CONDUCTIVE GARMENT ACCESSORY & LUMBAR SUPPORT KIT, MODELS 297, 298 | Bio-Medical Research, Ltd. | GZJ | Class II | 2009-03-11 |
| K082614 | EVOX ELECTRO DIAGNOSTIC DEVICE | Laborie Medical Technologies, Inc. | GWF | Class II | 2009-03-06 |
| K090001 | V-GRIP PLUS DETACHMENT CONTROLLER, MODEL VG503 | MicroVention, Inc. | HCG | Class II | 2009-03-05 |
| K090348 | CODMAN BACTISEAL EVD CATHETER SET, CODMAN BACTISEAL CLEAR EVD CATHETER SET | Codman & Shurtleff, Inc. | JXG | Class II | 2009-03-04 |
| K083124 | NIM 3.0 | Medtronic Xomed, Inc. | GWF | Class II | 2009-02-27 |
| K082057 | DX6605E-TENS, DX6605E-G, DX6609-G | Shenzhen Dongdixin Technology Co., Ltd. | GZJ | Class II | 2009-02-26 |
| K082404 | NAVIGATION PROBES | We Sense, Ltd. | GZL | Class II | 2009-02-25 |
| K083399 | ICS CHARTR EP 200 | Gn Otometrics A/S | GWJ | Class II | 2009-02-20 |
| K081255 | SCRAMBLER ST 5 TENS DEVICE | Competitive Technologies,Inc. | GZJ | Class II | 2009-02-20 |
| K083565 | PIGALILEO TOTAL HIP REPLACEMENT (THR) SOFTWARE APPLICATION V3.0 | Smith & Nephew, Inc. | HAW | Class II | 2009-02-20 |
| K083009 | ORTHO-MAP-ONCOLOGY NAVIGATION SOFTWARE, MODELS 6005-650-000, 6005-651-000 | Stryker Leibinger GmbH & Co KG | OLO | Class II | 2009-02-19 |
| K082377 | TENSCARE ITOUCH MODEL(S) EASY AND PLUS | Tenscare, Ltd. | GZJ | Class II | 2009-02-09 |
| K083030 | TENS-EMS-14 | Emsi | GZJ | Class II | 2009-02-05 |
| K090023 | IF SERIES TRUE SINE INTERFERENTIAL STIMULATOR, MODEL: WL-2206B AND WL-2106E | Well-Life Healthcare Limited | LIH | Class II | 2009-01-30 |
| K082035 | MAICO MB 11 WITH BERAPHONE PROBE | Maico Diagnostics | GWJ | Class II | 2009-01-29 |
| K081787 | CAMLAB CRANIAL ORTHOSIS HELMET | Biosculptor Corporation | OAN | Class II | 2009-01-27 |
| K081279 | PRO-TECH DELIVERY SYSTEM ELECTRODES, MODEL TT-2000 | Transfer Technology | GXY | Class II | 2009-01-23 |
| K083818 | UNIVERSAL ELECTRODES | Neurometrix, Inc. | GXY | Class II | 2009-01-21 |
| K083872 | IMNS MEDACTA NAVIGATION SYSTEM | Medacta International S.A. | OLO | Class II | 2009-01-15 |
| K072882 | PAIN VISION, MODEL PS-2100 | Osachi Co., Ltd. | LLN | Class I | 2009-01-08 |
| K083494 | ULTIMA FIVE | Pain Management Technologies | GZJ | Class II | 2009-01-06 |
| K083646 | MICRUS MICROCOLI SYSTEM, DELTAPLUSH, MODELS CPL, DPL | Micrus Endovascular Corporation | HCG | Class II | 2009-01-02 |
| K072964 | NICOLET CORTICAL STIMULATOR | Cardinal Health, Inc. | GYC | Class II | 2008-12-30 |
| K082010 | STRYKER DISPOSABLE CRANIAL PERFORATOR BIT | Stryker Ireland Ltd., Instruments Division | HBF | Class II | 2008-12-29 |
| K081551 | TWIN NEUROTRAC-III | Astro-Med, Inc. | OMA | Class II | 2008-12-24 |
| K082637 | CRANIAL PERFORATOR | The Anspach Effort, Inc. | HBF | Class II | 2008-12-22 |
| K083538 | NEUROSTAR TMS THERAPY SYSTEM, MODEL 1.1 | Neuronetics | OBP | Class II | 2008-12-16 |
| K083063 | BIS INTERFACE FOR VITALOGIK PATIENT MONITORS | Mennen Medical , Ltd. | OLW | Class II | 2008-12-16 |
| K083202 | COMBOCARE 2000 | Xanacare Technologies, LLC | GZJ | Class II | 2008-12-15 |
| K071573 | RUGALIFT, MODEL# V.2.1 | Fatrotek S.R.L. | NFO | Class II | 2008-12-09 |
| K080499 | MAGSTIM DOUBLE 70MM AIR FILM COIL, MODEL 3910-00 | The Magstim Company , Ltd. | GWF | Class II | 2008-12-08 |
| K082950 | STARBAND | Orthomerica Products, Inc. | OAN | Class II | 2008-12-05 |
| K082011 | MEDISTIM XP, TYPE 281 AND MEDITENS XP, TYPE 458 | Bio-Medical Research, Ltd. | GZJ | Class II | 2008-11-28 |
| K082540 | GE ENTROPY SENSOR | GE Healthcare | GXY | Class II | 2008-11-28 |
| K081867 | MAKO SURGICAL TACTILE GUIDANCE SYSTEM VERSION 2.0 | Mako Surgical Corp. | HAW | Class II | 2008-11-25 |
6,130 clearances in the Neurology panel. Data: openFDA.