Neurological Stereotaxic Instrument
Regulation 882.4560
5510(k)s in 12 months (426 all time)
7recalls in 12 months (202 all time)
199recalls that name a 510(k)
Top companies in HAW
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 12, 2000 | K003201 | STEALTHSTATION TREATMENT GUIDANCE PLATFORM Medtronic Surgical Navigation Technologies | HAW |
| Dec 4, 2000 | K002893 | FLUOROLAB PLUS Z-Kat, Inc. | HAW |
| Oct 2, 2000 | K002732 | STRYKER NAVIGATION SYSTEM - ENT MODULE Stryker Corp. | HAW |
| Sep 12, 2000 | K001642 | INSIGHT IMAGE GUIDED SURGICAL SYSTEM Surgical Insights, Inc. | HAW |
| Aug 3, 2000 | K002053 | NAVITRAK SYSTEM-OPTICAL OPTION, MODEL 900.004 Orthosoft, Inc., CA | HAW |
| Jul 26, 2000 | K001950 | OPTICAL TRACKING SYSTEM (OTS) Radionics, Inc. | HAW |
| Jun 30, 2000 | K001801 | STEATHSTATION TREATMENT GUIDANCE PLATFORM Medtronic Surgical Navigation | HAW |
| Jun 12, 2000 | K001284 | STEALTHSTATION SYSTEM GOLDENEYE MICRO-MAGNETIC TRACKING SYSTEM Medtronic Surgical Navigation Technologies | HAW |
| Jun 7, 2000 | K001192 | SELF ADHERING NAVIGUS GUIDE Image-Guided Neurologics, Inc. | HAW |
| May 17, 2000 | K001431 | MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS) Radionics, Inc. | HAW |
| May 3, 2000 | K001153 | MODIFICATION TO STEATHSTATION TREATMENT GUIDANCE PLATFORM Medtronic Surgical Navigation | HAW |
| Mar 13, 2000 | K000171 | CBYON SURGICAL OPERATING SYSTEM (SOS) Cbyon, Inc. | HAW |
| Feb 23, 2000 | K994421 | SNN STEREOTAXIC PLANNING APPLICATION; SNN STEREOTACTIC APPLICATION Surgical Navigation Specialists, Inc., CA | HAW |
| Feb 22, 2000 | K992461 | STEALTHSTATION TREATMENT GUIDANCE PLATFORM Surgical Navigation Technologies, Inc. | HAW |
| Feb 15, 2000 | K000310 | VOYAGER 6.0 SOFTWARE OPTION Philips Medical Systems (Cleveland), Inc. | HAW |
| Jan 18, 2000 | K993239 | STRYKER NAVIGATION SYSTEM - NEURO MODULE, MODEL 6000-XXX-XXX Stryker Corp. | HAW |
| Jan 11, 2000 | K992916 | BRAINLAB STEREOTACTIC ARC Brainlab | HAW |
| Dec 29, 1999 | K992927 | STEALTHSTATION TREATMENT GUIDANCE PLATFORM Surgical Navigation Technologies, Inc. | HAW |
| Dec 21, 1999 | K993673 | SNN FLUORO NAVIGATION SYSTEM I.S.G. Technologies, Inc., CA | HAW |
| Dec 7, 1999 | K991706 | VIRTUOSO-STEREOTAXIC PLANNING SOFTWARE Stryker Corp. | HAW |
| Nov 22, 1999 | K993501 | 3D1 MICROPOSITIONING HEADSTAGE Scientific Tools, Inc. | HAW |
| Nov 3, 1999 | K990683 | AXON MP-1 MICROPOSITIONER Axon Instruments, Inc. | HAW |
| Nov 2, 1999 | K992843 | THE MAYFIELD / ACCISS SYSTEM WITH WINDOWS NT FOR CRANIAL SURGERY, THE MAYFIELD / OPTICAL ACCISS SYSTEM WITH WINDOWS NT F Ohio Medical Instrument Co., Inc. | HAW |
| Oct 8, 1999 | K991256 | VIEWPOINT ENT/ORTHOPEDIC OPTION Philips Medical Systems (Cleveland), Inc. | HAW |
| Sep 24, 1999 | K992882 | LEKSELL IMAGE GUIDANCE SURGICAL SYSTEM, VIEW SCOPE, SURGISCOPE,ELEKTA INSIGHT Elekta Instrument AB | HAW |
| Sep 17, 1999 | K983410 | @ TARGET Brainlab AG | HAW |
| Sep 10, 1999 | K992721 | COSMAN ROBERT WELLS FUNCTIONAL PROBE MICRODRIVE Radionics, Inc. | HAW |
| Aug 27, 1999 | K992457 | SNN SYSTEM WITH OLIVIER DOUBLE CHUCK SUPPORT ARM OPTION Surgical Navigation Specialists, Inc., CA | HAW |
| Aug 27, 1999 | K992304 | NAVIGUS TRAJECTORY GUIDE, MODEL TG-XXXX Image-Guided Neurologics, Inc. | HAW |
| Aug 12, 1999 | K990907 | REMOTE INTRODUCER, MODEL PI-1000 Image-Guided Neurologics, Inc. | HAW |
| Jul 20, 1999 | K991636 | ELEKTA STEREOTACTIC GUIDE Elekta Instrument AB | HAW |
| Jul 12, 1999 | K991267 | SPINE APPLICATIONS FOR THE MAYFIELD/ACCISS OPERATING ARM AND OPTICAL ACCISS SYSTEMS MODULE, MAYFIELD/ACCISS SPINE RING A Ohio Medical Instrument Co., Inc. | HAW |
| Jul 8, 1999 | K983764 | VIEWPOINT TOOLS- STERRAD Philips Medical Systems (Cleveland), Inc. | HAW |
| Jun 25, 1999 | K991081 | FRAMELESS NEUROMATE Integrated Surgical Systems, Inc. | HAW |
| Jun 23, 1999 | K984298 | Z KAT FLUROTACTIC GUIDANCE SYSTEM MKI Z-Kat, Inc. | HAW |
| May 19, 1999 | K983831 | VECTORVISION2 Brainlab AG | HAW |
| Apr 29, 1999 | K990632 | OPTICAL TRACKING SYSTEM (OTS) Radionics, Inc. | HAW |
| Apr 22, 1999 | K990214 | FLUORONAV MODULE FOR THE STEALTHSTATION SYSTEM Surgical Navigation Technologies, Inc. | HAW |
| Mar 30, 1999 | K990868 | VIEWPOINT PASSIVE TOOL OPTION Philips Medical Systems (Cleveland), Inc. | HAW |
| Mar 30, 1999 | K990860 | VIEWPOINT MICROSCOPE OPTION Philips Medical Systems (Cleveland), Inc. | HAW |
| Mar 4, 1999 | K990326 | OPTICAL TRACKING SYSTEM MICROSCOPE MODULE II, MODEL OTS MMII Radionics Software Applications, Inc. | HAW |
| Feb 12, 1999 | K983539 | TRAJECTORY GUIDE, MODEL # TGX-XXX Image-Guided Neurologics, Inc. | HAW |
| Jan 28, 1999 | K981480 | PHILIPS EASYGUIDE Philips Medical Systems, Inc. | HAW |
| Jan 14, 1999 | K983670 | STEALTHSTATION SYSTEM Surgical Navigation Technologies, Inc. | HAW |
| Jan 13, 1999 | K982570 | SNN SCOUT I.S.G. Technologies, Inc., CA | HAW |
| Dec 18, 1998 | K984245 | NON-INVASIVE DYNAMIC REFERENCE FRAME (DRF) FOR OPTICAL TRACKING SYSTEM, MODEL OTS Radionics, Inc. | HAW |
| Dec 4, 1998 | K983397 | STEALTHSTATION TREATMENT GUIDANCE PLAFFORM Surgical Navigation Technologies, Inc. | HAW |
| Nov 23, 1998 | K981768 | STEALTHSTATION TREATMENT GUIDANCE PLATFORM Surgical Navigation Technologies, Inc. | HAW |
| Nov 18, 1998 | K983669 | OPTICAL TRACKING SYSTEM WITH SURFACE MATCHING MODULE, MODEL OTS Radionics, Inc. | HAW |
| Nov 10, 1998 | K983603 | REFLECTIVE SPHERE STANDARD PROBE AND REFLECTIVE SPHERE DYNAMIC REFERENCE FRAME Radionics, Inc. | HAW |
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