ClearanceBrief
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
Jun 5, 2014K140868STRYKER KWIC NEEDLE
Orthovita, Inc.
HAW
Apr 29, 2014K132755NEUROMATE FRAMELESS GEN II
Renishaw Mayfield Sarl, FR
HAW
Mar 6, 2014K132611MICROTABLE SYSTEM
Fred Haer Company, Inc.
HAW
Oct 18, 2013K131214CRANIAL MAP NEURO
Stryker Corporate, DE
HAW
Sep 27, 2013K130874STRYKER NAV3I PLATFORM
Stryker Corporate, DE
HAW
Aug 7, 2013K130608QUADCUT
Medtronic Navigation, Inc.
HAW
Dec 17, 2012K122211SYNTHES NAVIGABLE PEDICLE PREPARATION INSTRUMENTS
Synthes Spine
HAW
Sep 27, 2012K122096KARL STORZ NAVIGATIONPANEL UNIT (NPU) SYSTEM
KARL STORZ Endoscopy-America, Inc.
HAW
Jul 26, 2012K121950MICROTARGETING XL STAR DRIVE SYSTEM
FHC, Inc.
HAW
Jul 12, 2012K120812RENAISSANCE
Mazor Robotics , Ltd., IL
HAW
May 24, 2012K110644PRAEZIS PLUS
Tatramed Spol. S.R.O.
HAW
Apr 24, 2012K112094BRAIN BIOPSY NEEDLE
Ad-Tech Medical Instrument Corp
HAW
Mar 27, 2012K111558SURGICASE GUIDE
Materialise NV, BE
HAW
Mar 23, 2012K112469GENERAL PRUPOSE LOCALIZERS AND ADAPTERS-NEW ACCESSORIES FOR SONOWAND SYSTEM
Sonowand AS
HAW
Dec 1, 2011K113228RENAISSANCE SYSTEM
Mazor Robotics , Ltd., IL
HAW
Jun 3, 2011K101627IPLAN
Brainlab AG, DE
HAW
Apr 28, 2011K110911RENAISSANCE SYSTEM
Mazor Robotics , Ltd., IL
HAW
Feb 7, 2011K103192NAVIGATION MARKER, REFLECTIVE MARKER SPHERES
Ilumark GmbH, DE
HAW
Sep 23, 2010K101791ROSA SURGICAL DEVICE
Medtech S.A.S, FR
HAW
Aug 26, 2010K102130TENZING SYSTEM
Mazor Surgical Technologies , Ltd., IL
HAW
Jul 14, 2010K100038DISPOSABLE REFLECTIVE MARKER SPHERES
Brainlab AG, DE
HAW
May 6, 2010K092467VECTORVISION CRANIAL, VECTORVISION ENT, KOLIBRI CRANIAL, KOLIBRI ENT, CRANIAL ESSENTIAL, CRANIAL UNLIMITED
Brainlab AG, DE
HAW
Mar 31, 2010K100314IMNS MEDACTA NAVIGATION SYSTEM,33.221000US
Medacta International S.A.
HAW
Feb 12, 2010K092192WAYPOINT STEREOTACTIC SYSTEM
FHC, Inc.
HAW
Nov 17, 2009K092239ROSA SURGICAL DEVICE, MODEL ROSA 1.1
Medtech S.A, FR
HAW
Oct 9, 2009K090190WIN-NEUS STEREOTACTIC SURGERY TREATMENT PLANNING SYSTEM
Nuclemed S.A.
HAW
Sep 25, 2009K083597SONOWAND INVITE
Sonowand AS
HAW
Sep 18, 2009K092562MICROTARGETING STAR DRIVE SYSTEM, COMPONENTS
FHC, Inc.
HAW
Aug 6, 2009K090240MONTERIS MEDICAL UFO
Monteris Medical,
HAW
May 8, 2009K082060CRANIAL IMAGE GUIDED SURGERY SYSTEM
Brainlab AG, DE
HAW
May 1, 2009K080355LEKSELL STEREOTACTIC SYSTEM WITH REUSABLE FIXATION SCREWS
Elekta Instrument AB, SE
HAW
Feb 20, 2009K083565PIGALILEO TOTAL HIP REPLACEMENT (THR) SOFTWARE APPLICATION V3.0
Smith & Nephew, Inc.
HAW
Nov 25, 2008K081867MAKO SURGICAL TACTILE GUIDANCE SYSTEM VERSION 2.0
Mako Surgical Corp.
HAW
Oct 29, 2008K082267PIGALILEO CAS, VERSION 4.0 AND TKR BASE, VERSION 2.1
Smith & Nephew, Inc.
HAW
Sep 5, 2008K073615BRAINLAB KNEE ESSENTIAL, BRAINLAB KNEE UNLIMITED CI KNEE, CI KNEE UNLIMITED
Brainlab AG, DE
HAW
Aug 6, 2008K081232TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH PRAXITELES
Praxim, FR
HAW
Jul 18, 2008K080875PIGALILEO 4TH GENERATION SYSTEM
Smith & Nephew, Inc.
HAW
Jul 17, 2008K080450STRYKER POWER TOOL NAVIGATOR ATTACHMENT
Stryker Corp.
HAW
Jun 6, 2008K080678UNI-KNEE 2.0
Brainlab AG, DE
HAW
May 23, 2008K080547ORTHOPILOT NEXT GENERATION, MODEL FS101-FS106
Aesculap Implant System, Inc.
HAW
May 23, 2008K073467SPINEASSIST SYSTEM
Mazor Surgical Technologies , Ltd., IL
HAW
May 13, 2008K080250LEKSELL SURGIPLAN, MODEL 1006947
Elekta Instrument AB, SE
HAW
Feb 6, 2008K072899ORTHOPILOT 2 TOTAL HIP ARTHROPLASTY (THA) VERSION 3.0
Aesculap Implant Systems, Inc.
HAW
Jan 24, 2008K072806MAKO SURGICAL TACTILE GUIDANCE SYSTEM (TGS)
Mako Surgical Corp.
HAW
Dec 18, 2007K072271STRYKER NAVIGATION SYSTEM INFINITUS HIP RESURFACING MODULE
Stryker Corp.
HAW
Dec 10, 2007K072267TOTAL HIP SURGETICS NAVIGATION SYSTEM
Praxim S.A, FR
HAW
Oct 12, 2007K072716VECTOR VISION HIP
Brainlab AG, DE
HAW
Oct 11, 2007K072573VECTORVISION HIP AND HIP SR
Brainlab AG, DE
HAW
Sep 25, 2007K070556BRAINSUITE NET
Brainlab AG, DE
HAW
Sep 19, 2007K071929NAVITRACK SYSTEM- PARTIAL HIP RESURFACING UNIVERSAL
Orthosoft, Inc., CA
HAW

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