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Panels › Neurology › Product code HAW · Class 2

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)
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Top companies in HAW

Company510(k)sRecalls
Medtronic Navigation1967
Brainlab599
FHC, Inc.624
Elekta Instrument AB164
Stryker Instruments Division of Stryker Corporation019
Stryker Instruments Div. of Stryker Corporation017
Zimmer Biomet, Inc.016
Image-Guided Neurologics, Inc.150
Surgical Navigation Technologies, Inc.150
Medtronic Surgical Navigation Technologies111
Decided510(k)Device and applicantCode
Aug 23, 2007K063607SPINEASSIST SYSTEM
Mazor Surgical Technologies , Ltd., IL
HAW
Jul 31, 2007K070731PIGALILEO TOTAL HIP REPLACEMENT (THR) SYSTEM
Plus Orthopedics AG
HAW
Jul 20, 2007K071714NAVITRACK SYSTEM - OS UNICONDYLAR KNEE UNIVERSAL, MODEL# PRO-06003
Orthosoft, Inc., CA
HAW
Jul 2, 2007K071334DEPUY CAS HEMI ASR HIP INSTRUMENTS
DePuy Orthopaedics, Inc.
HAW
May 23, 2007K071135DEPUY CI HIP INSTRUMENTATION
DePuy Orthopaedics, Inc.
HAW
Apr 23, 2007K070106VV FLUORO 3D
Brainlab AG, DE
HAW
Apr 5, 2007K061479ARGOS
3D Line Medical Systems S.R.L., IT
HAW
Feb 28, 2007K063408CTLOGICS NAVIGATIONS SYSTEMS
Praxim Medivision, SA, FR
HAW
Jan 17, 2007K062358MODIFICATION TO VECTORVISION TRAUMA
Brainlab AG, DE
HAW
Dec 14, 2006K062640STRYKER NAVIGATION SYSTEM - CRANIAL MODULE, MODEL 6000-650-000
Stryker Instruments
HAW
Dec 12, 2006K063028VECTORVISION HIP SR
Brainlab AG, DE
HAW
Nov 8, 2006K062228ZIMMER HIP COMPUTER ASSISTED SOLUTIONS ELECTROMAGNETIC AND IMAGELESS INSTRUMENTATION
Zimmer, Inc.
HAW
Oct 6, 2006K061362PIGALILEO TOTAL KNEE REPLACEMENT (TKR) SYSTEM
Plus Orthopedics AG
HAW
Sep 20, 2006K062086NAVIVISION
Brainlab AG, DE
HAW
Sep 5, 2006K061224LAPDOC I
Robodent GmbH, DE
HAW
Aug 31, 2006K061248AXIEM IMAGELESS HIP MODULE FOR THE STEALTHSTATION SYSTEM
Medtronic Navigation, Inc.
HAW
Aug 21, 2006K062146UNI KNEE SURGETICS NAVIGATION SYSTEM
Praxim S.A, FR
HAW
Aug 21, 2006K060727VECTORVISION HIP
Brainlab AG, DE
HAW
Aug 4, 2006K053348STRYKER ORTHOPAEDICS RFID INSTRUMENTATION
Howmedica Osteonics Corp.
HAW
Jul 31, 2006K060556BRIGIT SURGICAL DEVICE
Zimmer, Inc.
HAW
Jul 25, 2006K060808BRAINPRO, BRAINPRO ACCESS
PAJUNK GmbH Medizintechnologie, DE
HAW
Jun 6, 2006K053159VECTORVISION SPINE
Brainlab AG, DE
HAW
Apr 28, 2006K060336NAVITRACK SYSTEM-OS KNEE UNIVERSAL, MODEL PRO-05002
Orthosoft, Inc., CA
HAW
Apr 10, 2006K060282TOTAL KNEE SURGETICS NAVIGATION SYSTEM
Praxim S.A
HAW
Apr 10, 2006K053542SURGETICS ORTHO OSTEOLOGICS NAVIGATION SYSTEM
Praxim S.A
HAW
Mar 23, 2006K053164IPLAN FLOW
Brainlab AG, DE
HAW
Mar 21, 2006K060121BIOMET PRE-CALIBRATED COMPUTER AIDED SURGERY NAVIGATION INSTRUMENTS FOR HIP APPLICATIONS
Biomet Manufacturing Corp
HAW
Mar 20, 2006K060468VECTORVISION HIP
Brainlab AG, DE
HAW
Mar 2, 2006K052623IMAGELESS HIP MODULE FOR THE STEALTHSTATION SYSTEM
Medtronic Navigation, Inc.
HAW
Feb 13, 2006K052966CI KNEE, CI MI TKR
Brainlab AG, DE
HAW
Feb 9, 2006K053127IPLAN
Brainlab AG, DE
HAW
Dec 28, 2005K052425ZIMMER COMPUTER ASSISTED SOLUTIONS-ELECTROMAGNETIC AND IMAGELESS KNEE INSTRUMENTATION
Zimmer, Inc.
HAW
Dec 16, 2005K052840IGI-SYSTEM
Denx Advanced Dental Systems, IL
HAW
Nov 23, 2005K051734GE HEALTHCARE INSTA TRAK 3500PLUS/ FLUORO TRAK 9800 PLUS SYSTEM WITH AXCESS BONE PIN, MODEL PART # 1006955
Ge Healthcare Technologies
HAW
Nov 18, 2005K052851VOYAGER LINUX WITH TACTILE GUIDANCE SYSTEM (TGS)
Mako Surgical Corp.
HAW
Nov 2, 2005K052213NAVIGATION SW HIP 3.1 ON CI
Brainlab AG, DE
HAW
Oct 21, 2005K052178DEPUY CAS HIP INSTRUMENTATION
DePuy Orthopaedics, Inc.
HAW
Sep 8, 2005K051676SPINEASSIST DEVICE WITH ADDITIONAL ACCESSORIES
Mazor Surgical Technologies , Ltd., IL
HAW
Jul 27, 2005K050651MEDTRONIC ORTHOPAEDIC TRAUMA APPLICATION
Medtronic Navigation, Inc.
HAW
Jul 25, 2005K051746ELEKTA ESARTE FRAME SYSTEM
Elekta Instrument AB, SE
HAW
Jul 19, 2005K051724ACUMEN IMAGE GUIDED SURGICAL SYSTEM
Ebi, L.P.
HAW
Jun 8, 2005K051029STELTHSTATION WIRELESS SURGEON MOUSE
Medtronic Surgical Navigation
HAW
Jun 7, 2005K031196SURGETICS ORTHO KNEELOGICS NAVIGATION SYSTEM
Praxim
HAW
Jun 2, 2005K050438STEALTHSTATION SYSTEM UPDATE
Medtronic Surgical Navigation Technologies
HAW
Jun 1, 2005K041897MAYFIELD ACCISS II IMAGE GUIDED SURGERY SYSTEM, MODEL 2002-01
Schaerer Mayfield USA, Inc.
HAW
May 24, 2005K050897NAVIPRO SHOULDER SOFTWARE MODULE
Kinamed, Inc.
HAW
May 17, 2005K050973MODIFICATION TO: VOYAGER LINUX
Mako Surgical Corp.
HAW
May 17, 2005K042543IPLAN! DIGITAL TEMPLATING
Brainlab AG, DE
HAW
Apr 27, 2005K050752AESCULAP ORTHOPILOT 2 THA V 2.0
Aesculap, Inc.
HAW
Apr 21, 2005K050772NAVIGUS REUSABLE PASSIVE PROBE, MODEL SP-2000
Image-Guided Neurologics, Inc.
HAW

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