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 |
|---|---|---|---|
| Oct 29, 1998 | K981508 | VECTORVISION SPINE MODULE Brainlab AG | HAW |
| Oct 13, 1998 | K980820 | PHILIPS EASYGUIDE Philips Medical Systems, Inc. | HAW |
| Sep 23, 1998 | K982244 | MAYFIELD ACCISS OPTICAL SYSTEM Ohio Medical Instrument Co., Inc. | HAW |
| Aug 24, 1998 | K961903 | MAGELLAN Biosense, Ltd., IL | HAW |
| Aug 14, 1998 | K981809 | CAROLINE GUIDE Surgical Solutions, Inc. | HAW |
| Aug 7, 1998 | K981686 | STEALTHSTATION SYSTEM DIGITIZER CHANGE Surgical Navigation Technologies, Inc. | HAW |
| Aug 6, 1998 | K981684 | STEALTHSTATION TREATMENT GUIDANCE PLATFORM Surgical Navigation Technologies, Inc. | HAW |
| Aug 5, 1998 | K982364 | WIRELESS STANDARD PROBE, DYNAMIC REFERENCE FRAME (DRF) Radionics, Inc. | HAW |
| Jul 9, 1998 | K981315 | NAVITRACK Orthosoft, Inc., CA | HAW |
| Jul 1, 1998 | K981213 | UNIVERSAL INSTRUMENT REGISTRATION (UIR) MICROSCOPE MODULE I Radionics, Inc. | HAW |
| May 18, 1998 | K980584 | ATLASPLAN Radionics, Inc. | HAW |
| Apr 21, 1998 | K974602 | OPTICAL TRACKING SYSTEM (OTS) Radionics Software Applications, Inc. | HAW |
| Mar 31, 1998 | K973684 | LEKSELL VIEWSCOPE, LEKSELL SURGISCOPE, LEKSELL FREEHAND Elekta Instrument AB | HAW |
| Mar 2, 1998 | K972324 | LEKSELL STEREOTACTIC SYSTEM Elekta Instrument AB | HAW |
| Jan 21, 1998 | K974187 | STEALTHSTATION SYSTEM Surgical Navigation Technologies, Inc. | HAW |
| Nov 21, 1997 | K974161 | STEALTHSTATION SYSTEM Surgical Navigation Technologies, Inc. | HAW |
| Nov 17, 1997 | K973277 | CAROLINE GUIDE/DELIA LOCALIZER Surgical Solutions, Inc. | HAW |
| Sep 16, 1997 | K972398 | STEALTHSTATION PASSIVE INSTRUMENT OPTION Surgical Navigation Technologies, Inc. | HAW |
| Aug 19, 1997 | K964229 | REGULUS NAVIGATOR Compass Intl., Inc. | HAW |
| Jul 14, 1997 | K971675 | SNT STEREOTACTIC LOCALIZATION SYSTEM Surgical Navigation Technologies, Inc. | HAW |
| Jun 16, 1997 | K971247 | SNT DISPOSABLE BIOPSY NEEDLE Surgical Navigation Technologies, Inc. | HAW |
| Jun 4, 1997 | K970865 | ISG FAMILY OF VIEWING WANDS I.S.G. Technologies, Inc., CA | HAW |
| Jun 2, 1997 | K964801 | OPTICAL TRACKING SYSTEM (OTS) Radionics Software Applications, Inc. | HAW |
| May 22, 1997 | K962939 | VECTORVISION Brainlab, Inc. | HAW |
| May 19, 1997 | K970604 | VIEWPOINT - 3.0 SOFTWARE Philips Medical Systems (Cleveland), Inc. | HAW |
| May 9, 1997 | K963256 | NEUROMATE STEREOTACTIC SYSTEM Integrated Surgical Systems, S.A. | HAW |
| Apr 23, 1997 | K965139 | SURGICAL MICROSCOPE NAVIGATOR (SMN) SYSTEM/SURGICAL TOOL NAVIGATOR (STN) SYSTEM Carl Zeiss, Inc. | HAW |
| Jan 10, 1997 | K963221 | OPTICAL DIGITIZER OPTION FOR VIEW POINT Philips Medical Systems (Cleveland), Inc. | HAW |
| Nov 8, 1996 | K961834 | PHILIPS EASYGUIDE NEURO Philips Medical Systems, Inc. | HAW |
| Oct 25, 1996 | K963173 | STEALTHSTATION SYSTEM Surgical Navigation Technologies, Inc. | HAW |
| Oct 23, 1996 | K961844 | OPERATING ARM SYSTEM (OAS) [WITH CT AND MR IMAGES] Radionics Software Applications, Inc. | HAW |
| Aug 12, 1996 | K954789 | BRAINLAB HEADPINS Brainlab AG | HAW |
| Aug 7, 1996 | K961858 | COSGROVE DEPTH ELECTRODE KIT(CDEK) Radionics, Inc. | HAW |
| Jul 26, 1996 | K961639 | LEKSELL IMAGE GUIDANCE SURGICAL SYSTEM (LIGS) Elekta Instrument AB, SE | HAW |
| May 29, 1996 | K960714 | ISG VIEWING WAND I.S.G. Technologies, Inc., CA | HAW |
| May 10, 1996 | K961120 | MARKER SYSTEM FOR STEREOTAXIC NAVIGATION Howmedica Leibinger, Inc. | HAW |
| Apr 30, 1996 | K955397 | MAYFIELD-ACCISS WORKSTATION Nomos Corp. | HAW |
| Feb 29, 1996 | K953568 | CODMAN FIDUCIAL MARKER SYSTEM Codman & Shurtleff, Inc. | HAW |
| Feb 2, 1996 | K952390 | BRAINLAB STEROTATIC HEADRING Brainlab Med. Computersysteme GmbH, DE | HAW |
| Jan 24, 1996 | K954276 | STEALTHSTATION Surgical Navigation Technologies, Inc. | HAW |
| Oct 26, 1995 | K944463 | CRW-1 SYSTEM Radionics Software Applications, Inc. | HAW |
| Oct 13, 1995 | K935456 | REGULUS MEASUREMENT UNIT Compass Intl., Inc. | HAW |
| Sep 1, 1995 | K946033 | LEIBINGER STEREOPLAN PLUS STEROTACTIC TREATMENT PLAN ING SOFTWARE PACKAGE Leibinger GmbH | HAW |
| Mar 14, 1995 | K946252 | STEREOPLAN Radionics Software Applications, Inc. | HAW |
| Jan 20, 1995 | K943468 | LEKSELL SURGIPLAN Elekta Instruments, Inc. | HAW |
| Mar 22, 1994 | K936019 | NOMOS STEREOTACTIC BIOPSY INSTRUMENTS Nomos Corp. | HAW |
| Aug 20, 1993 | K931991 | GNOMOS STEREOTACTIC SYSTEM W/ NONINVASIVE FIXATION Nomos Corp. | HAW |
| Nov 23, 1992 | K924348 | AD-TECH'S BRAIN BIOPSY NEEDLE FOR STEREOTAXIC Ad-Tech Medical Instrument Corp | HAW |
| Jul 10, 1992 | K915791 | CORITAXIC MULTI-MODAL STEREOTAXI WORKSTATION Coritechs, Inc. | HAW |
| May 11, 1992 | K915819 | BRAINSCAN WORKSTATION Brainlab Medizinische Computersysteme GmbH, GR | HAW |
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