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 |
|---|---|---|---|
| Apr 21, 2005 | K050615 | STRYKER NAVIGATION SYSTEM - CT-BASED HIP MODULE, MODEL 6007-621-000 Stryker Instruments | HAW |
| Apr 19, 2005 | K042721 | KOLIBRI SPINE Brainlab AG, DE | HAW |
| Apr 7, 2005 | K050377 | NBD HEAD SCREW New Business Development, LLC | HAW |
| Mar 4, 2005 | K043223 | DEPUY CAS KNEE INSTRUMENTATION DePuy Orthopaedics, Inc. | HAW |
| Feb 10, 2005 | K042513 | VECTORVISION OSTEOTOMY Brainlab AG, DE | HAW |
| Feb 7, 2005 | K043091 | NAVIGUS NEXDRIVE, MODEL MI-3000 Image-Guided Neurologics, Inc. | HAW |
| Jan 14, 2005 | K043536 | NAVITRACK SYSTEM - S&N IMAGE FREE KNEE Orthosoft, Inc., CA | HAW |
| Jan 13, 2005 | K042512 | VECTORVISION ACL Brainlab AG, DE | HAW |
| Jan 5, 2005 | K043088 | MEDTRONIC SNT STEALTHSTATION AXIEM IMAGELESS KNEE MODULE Medtronic Surgical Navigation Technologies | HAW |
| Dec 9, 2004 | K041477 | PATHFINDER Armstrong Healthcare Limited, GB | HAW |
| Oct 22, 2004 | K041703 | IPLAN! Brainlab AG, DE | HAW |
| Oct 19, 2004 | K042391 | KOLIBRI IMAGE GUIDED SURGERY SYSTEM Brainlab AG, DE | HAW |
| Oct 6, 2004 | K041899 | VECTORVISION UNI-KNEE Brainlab AG, DE | HAW |
| Oct 4, 2004 | K040334 | NAVIGUS PASSIVE PROBE, MODEL NP-1000 Image-Guided Neurologics, Inc. | HAW |
| Sep 22, 2004 | K041330 | IPLAN! FLOW Brainlab AG, DE | HAW |
| Sep 10, 2004 | K033341 | SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR HIP APPLICATIONS Smith & Nephew, Inc. | HAW |
| Aug 23, 2004 | K040368 | VECTORVISION HIP 3.0 Brainlab AG, DE | HAW |
| Jul 23, 2004 | K040979 | ELEKTA MICRODRIVE, MODEL 916716 Elekta Instrument AB, SE | HAW |
| Jul 8, 2004 | K031454 | ACUMEN SURGICAL NAVIGATION SYSTEM Biomet, Inc. | HAW |
| Jun 22, 2004 | K041369 | NAVITRACK SYSTEM - S&N IMAGE FREE HIP, MODEL PRO-03017 Orthosoft, Inc., CA | HAW |
| Jun 3, 2004 | K040834 | NAVIGUS PASSIVE PROBE (BL), MODEL NP-2000 Image-Guided Neurologics, Inc. | HAW |
| Mar 11, 2004 | K033668 | NAVIPRO KNEE SOFTWARE MODULE Kinamed, Inc. | HAW |
| Mar 2, 2004 | K033619 | NAVIGUS UNIBODY FIDUCIAL MARKER SYSTEM, MODEL FM-4000 Image-Guided Neurologics, Inc. | HAW |
| Feb 18, 2004 | K033223 | ZIMMER ORTHO GUIDANCE SYSTEMS- HIP INSTRUMENTS Zimmer, Inc. | HAW |
| Feb 17, 2004 | K023651 | VECTORVISION CRANIAL/ENT Brainlab AG, DE | HAW |
| Feb 12, 2004 | K033340 | LEKSELL SURGIPLAN WITH IMAGEMERGE Elekta Instrument AB, SE | HAW |
| Feb 12, 2004 | K033011 | ZIMMER ORTHO GUIDANCE SYSTEMS- KNEE INSTRUMENTS Zimmer, Inc. | HAW |
| Jan 27, 2004 | K033621 | NDI PASSIVE SPHERES Northern Digital, Inc., CA | HAW |
| Jan 7, 2004 | K033413 | SPINEASSIST DEVICE Mazor Surgical Technologies , Ltd., IL | HAW |
| Oct 21, 2003 | K032917 | NAVITRACK SYSTEM - TOTAL HIP REPLACEMENT CT-FREE Orthosoft, Inc., CA | HAW |
| Oct 15, 2003 | K031732 | EBI ACUMEN SURGICAL NAVIGATION SYSTEM Ebi, L.P. | HAW |
| Sep 15, 2003 | K032054 | RADIONICS NASHOLD BIOPSY NEEDLE - SINGLE USE Radionics, A Division of Tyco Healthcare Group LP | HAW |
| Sep 15, 2003 | K031337 | ACUMEN SURGICAL NAVIGATION SYSTEM Biomet, Inc. | HAW |
| Aug 12, 2003 | K031770 | CI TKR/UKR Brainlab AG, DE | HAW |
| Jul 25, 2003 | K031999 | ELEKTA LEKSELL STEREOTACTIC SYSTEM WITH MR POST KIT Elekta Instrument AB, SE | HAW |
| Jul 25, 2003 | K031980 | MODIFICATION TO LEKSELL STEREOTACTIC SYSTEM Elekta Instrument AB, SE | HAW |
| Jun 11, 2003 | K024192 | VECTORVISION FLUORO3D Brainlab AG, DE | HAW |
| Jun 2, 2003 | K022579 | STRYKER NAVIGATION SYSTEM-KNEE MODULE Stryker Leibinger | HAW |
| May 23, 2003 | K030827 | NAVITRACK SYSTEM: TOTAL HIP REPLACEMENT CT-FREE CUP, MODEL 900.204 Orthosoft, Inc., CA | HAW |
| May 9, 2003 | K031156 | NAVITRACK SYSTEM-FLUOROSPINE, MODEL 900.005 Orthosoft, Inc., CA | HAW |
| May 9, 2003 | K023424 | IGI-SYSTEM Denx Advanced Dental Systems, IL | HAW |
| May 2, 2003 | K030343 | DIEGO POWERED DISSECTOR HANDPIECE WITH STARLINK IMAGE-GUIDED ADAPTER MOUNTING INTERFACE Gyrus Ent LLC | HAW |
| Apr 24, 2003 | K030764 | Z-BOX Z-Kat, Inc. | HAW |
| Mar 19, 2003 | K030552 | IMAGELESS KNEE MODULE FOR THE STEALTHSTATION SYSTEM Medtronic Surgical Navigation Technologies | HAW |
| Mar 12, 2003 | K024201 | NAVIGUS FIDUCIAL MARKER SYSTEM, MODELS FM-1000, FM-2000 Image-Guided Neurologics, Inc. | HAW |
| Feb 25, 2003 | K023949 | NAVIGUS II TRAJECTORY GUIDE WITH VERIFICATION RETICULES Image-Guided Neurologics, Inc. | HAW |
| Feb 12, 2003 | K030106 | STEALTHSTATION SYSTEM ADVANCED CONTOUR REGISTRATION SOFTWARE MODULE Medtronic Surgical Navigation Technologies | HAW |
| Feb 4, 2003 | K022364 | NAVITRACK SYSTEM TOTAL HIP REPLACEMENT,MODEL 900.200 Orthosoft, Inc., CA | HAW |
| Jan 22, 2003 | K022365 | STRYKER NAVIGATION SYSTEM - HIP MODULE Stryker Instruments | HAW |
| Jan 3, 2003 | K022126 | CATHETER INTRODUCER FOR THE STEALTHSTATION SYSTEM Medtronic Surgical Navigation Technologies | HAW |
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