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 20, 2002 | K023975 | VOYAGER LINUX Z-Kat, Inc. | HAW |
| Dec 9, 2002 | K021798 | SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR HIP APPLICATIONS Smith & Nephew, Inc. | HAW |
| Nov 19, 2002 | K021980 | HIP MODULE FOR THE STEALTHSTATION SYSTEM Medtronic Surgical Navigation Technologies | HAW |
| Oct 25, 2002 | K021306 | VECTORVISION CT-FREE KNEE Brainlab AG, DE | HAW |
| Oct 17, 2002 | K021815 | SMITH & NEPHEW IMAGE SURGICAL INSTRUMENTS FOR TRAUMA APPLICATIONS Smith & Nephew, Inc. | HAW |
| Sep 25, 2002 | K022100 | NAVIGUS MANUAL DISPOSABLE MICRODRIVE WITH DIGITAL DISPLAY, MODELS MI-1000 & MI-1010 Image-Guided Neurologics, Inc. | HAW |
| Sep 9, 2002 | K020631 | IPLAN Brainlab AG, DE | HAW |
| Aug 27, 2002 | K021760 | NAVITRACK SYSTEM-OPTICAL TKR CT-LESS, MODEL 900.120 Orthosoft, Inc., CA | HAW |
| Aug 19, 2002 | K022460 | SMITH & NEPHEW IMAGE GUIDED SURGICAL SYSTEM FOR KNEE APPLICATIONS Smith & Nephew, Inc. | HAW |
| Aug 14, 2002 | K022414 | STEALTHSTATION SYSTEM THREE DIMENSIONAL C-ARM INTERFACE Medtronic Surgical Navigation Technologies | HAW |
| Aug 13, 2002 | K022074 | SPHERZ I.Z.I. Corp. | HAW |
| Aug 7, 2002 | K013396 | ALPHA DRIVE SYSTEM Alpha Omega , Ltd., IL | HAW |
| Jul 25, 2002 | K021327 | ORTHOPILOT HTO MODULE Aesculap, Inc. | HAW |
| Jul 19, 2002 | K014256 | KOLIBRI IGS SYSTEMS Brainlab AG, DE | HAW |
| Jun 14, 2002 | K014113 | ENDOMAP Siemens Medical Solutions USA, Inc. | HAW |
| Jun 3, 2002 | K020764 | NAVIPRO Kinamed, Inc. | HAW |
| May 20, 2002 | K020298 | GALILEO CAS/NAV TKR SYSTEM Plus Orthopedics | HAW |
| Apr 4, 2002 | K013569 | ORTHOPILOT 2 Aesculap, Inc. | HAW |
| Apr 4, 2002 | K013428 | MAYFIELD/ACCISS OPERATING ARM SYSTEM AND MAYFIELD/OPTICAL ACCISS SYSTEM Ohio Medical Instrument Co., Inc. | HAW |
| Mar 14, 2002 | K012448 | VECTORVISION TRAUMA Brainlab AG, DE | HAW |
| Feb 27, 2002 | K020338 | STEALTHSTATION WITH FLUOROMERGE SOFTWARE Medtronic Surgical Navigation Technologies | HAW |
| Feb 8, 2002 | K012938 | SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR KNEE APPLICATIONS Smith & Nephew, Inc. | HAW |
| Jan 25, 2002 | K012937 | KNEE MODULE FOR THE STEALTHSTATION SYSTEM Medtronic Surgical Navigation Technologies | HAW |
| Dec 20, 2001 | K011255 | 3D LINE STEROTACTIC HARDWARE ACCESSORIES 3D Line USA, Inc. | HAW |
| Dec 6, 2001 | K013861 | MODIFICATION TO LEKSELL SURGIPLAN WITH ATLASPACE Elekta Instrument AB | HAW |
| Dec 3, 2001 | K012380 | MODIFICATION TO: STRYKER NAVIGATION SYSTEM, STRYKER FLUOROSCOPY SYSTEM,VIRTUAL FLUOROSCOPY Stryker Leibinger | HAW |
| Oct 30, 2001 | K013257 | HEMI-ARC SURGICAL NAVIGATOR Nuvasive, Inc. | HAW |
| Oct 22, 2001 | K012719 | NAVIGUS II MR Image-Guided Neurologics, Inc. | HAW |
| Oct 9, 2001 | K012886 | CBYON SYSTEM WITH IMAGE ENHANCED FLUOROSCOPY MODULE Cbyon, Inc. | HAW |
| Oct 3, 2001 | K013025 | MODIFICATION TO FLOUROLAB PLUS Z-Kat, Inc. | HAW |
| Oct 1, 2001 | K012366 | NAVIGUS II TRAJECTORY GUIDE Image-Guided Neurologics, Inc. | HAW |
| Sep 12, 2001 | K010602 | VECTORVISION HIP Brainlab AG, DE | HAW |
| Sep 6, 2001 | K012564 | MODIFICATION TO: VECTORVISION FRAMELESS BIOPSY SYSTEM Brainlab AG, DE | HAW |
| Sep 6, 2001 | K010612 | VECTORVISION KNEE Brainlab AG, DE | HAW |
| Aug 31, 2001 | K010204 | STRYKER NAVIGATION SYSTEM-KNEE MODULE Stryker Corp. | HAW |
| Aug 30, 2001 | K011775 | MICRO TARGETING DRIVE SYSTEM FHC, Inc. | HAW |
| Aug 30, 2001 | K010968 | VECTORVISION CT/FLUORO Brainlab AG, DE | HAW |
| Aug 14, 2001 | K011992 | FHC MICROTARGETING DRIVE SYSTEM FHC, Inc. | HAW |
| Aug 3, 2001 | K011971 | NAVIGUS TRAJECTORY GUIDE BIOPSY KIT, MODELS BK-7000 AND 8000 Image-Guided Neurologics, Inc. | HAW |
| May 21, 2001 | K003589 | VECTORVISION CRANIAL, VECTORVISION SPINAL, VECTORVISION ENT Brainlab AG, DE | HAW |
| May 17, 2001 | K003486 | STEREOTACTIC FRAME BASED SYSTEM Stryker Instruments | HAW |
| May 8, 2001 | K010542 | SNN SYSTEM INCLUDING THE TOMOGUIDE OPTION Surgical Navigation Specialists, Inc., CA | HAW |
| Mar 15, 2001 | K010427 | LORENZ FIDUCAIL SCREW Walter Lorenz Surgical, Inc. | HAW |
| Mar 12, 2001 | K010548 | MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS) Radionics, A Division of Tyco Healthcare Group LP | HAW |
| Feb 27, 2001 | K003699 | MEDIVISION IGS SYSTEM Medivision (U.S.A.), Inc. | HAW |
| Feb 23, 2001 | K003776 | MICROTARGETING DRIVE SYSTEM FHC, Inc. | HAW |
| Feb 23, 2001 | K003347 | ORTHOPILOT Kinamed, Inc. | HAW |
| Feb 22, 2001 | K003268 | Z-TOUCH Brainlab AG | HAW |
| Jan 24, 2001 | K004027 | STRYKER REMOTE SURGICAL PLANNING SYSTEM Stryker Instruments | HAW |
| Jan 4, 2001 | K003111 | STRYKER NAVIGATION SYSTEM-SPINE & FLUOROSCOPY MODULES Stryker Instruments | HAW |
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