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Data / Medical devices / Neurological Stereotaxic Instrument

Neurological Stereotaxic Instrument (HAW): 194 FDA-registered makers in 19 countries

194 establishments in 19 countries are registered with the FDA to make Neurological Stereotaxic Instrument (product code HAW, Class 2, 21 CFR 882.4560). 70 of them have a 510(k) clearance or PMA approval on file and 13 have a recall event. The FDA has issued 426 510(k) clearances under this code, the latest on October 15, 2026, and lists 116 recall events (15 Class I). FDA data exported November 2, 2026.

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Product code
HAW
Device class
2
Regulation
882.4560
Medical specialty
Neurology

Makers by country

CountryMakers
United States110
Germany22
Switzerland11
Canada9
France7
Israel5
Malaysia5
South Korea4
China4
Sweden3
Netherlands3
Mexico3
United Kingdom2
Taiwan1
Belgium1
Colombia1
Denmark1
Finland1
India1

Makers of Neurological Stereotaxic Instrument

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Medtronic Navigation, Inc.Lafayette, CO, United StatesManufacturer, Repackager or relabeler, Specification developer41March 26, 20260357api.fda.gov
Brainlab SeMunich Bavaria, GermanyExporter to the US, Manufacturer17January 28, 2025092api.fda.gov
Stryker Leibinger GMBH & Co. KGFREIBURG Baden-Wurttemberg, GermanyComplaint file establishment, Manufacturer, Specification developer12February 16, 2023010api.fda.gov
FHC, Inc.Bowdoin, ME, United StatesComplaint file establishment, Manufacturer9July 26, 2012061api.fda.gov
Zimmer CasMontreal, Quebec, CanadaManufacturer9July 20, 2007040api.fda.gov
ClearPoint Neuro Inc.Carlsbad, CA, United StatesManufacturer7January 24, 2025000api.fda.gov
Integra Lifesciences CorporationCincinnati, OH, United StatesManufacturer5December 6, 2016000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer5January 14, 2005000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer5January 14, 2005000api.fda.gov
Synaptive Medical IncMississauga Ontario, CanadaExporter to the US, Manufacturer5July 14, 2019021api.fda.gov
7D Surgical ULCToronto Ontario, CanadaManufacturer, Specification developer4December 27, 2024000api.fda.gov
Aesculap AGTUTTLINGEN, DONAU Baden-Wurttemberg, GermanyComplaint file establishment, Manufacturer4May 23, 2008000api.fda.gov
Izi Medical Products LLCOwings Mills, MD, United StatesManufacturer, Repackager or relabeler4April 13, 2015000api.fda.gov
COMPASS International Innovations, Inc.Rochester, MN, United StatesManufacturer, Specification developer3August 19, 1997000api.fda.gov
Depuy Orthopaedics, Inc.Warsaw, IN, United StatesManufacturer, Repackager or relabeler, Specification developer3May 23, 2007000api.fda.gov
Depuy Orthopaedics, Inc.Raynham, MA, United StatesManufacturer, Specification developer3May 23, 2007000api.fda.gov
Elekta Solutions ABStockholm, SwedenExporter to the US, Manufacturer, Specification developer3August 5, 2026000api.fda.gov
Mazor Robotics Ltd.Caesarea Haifa, IsraelManufacturer3July 12, 2012010api.fda.gov
Medtech SASMAUGUIO Occitanie, FranceManufacturer3July 20, 2023042api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer3January 14, 2005000api.fda.gov
Ad-Tech Medical Instrument Corp.Oak Creek, WI, United StatesManufacturer2April 24, 2012000api.fda.gov
ClaroNav Inc.Toronto Ontario, CanadaManufacturer2February 5, 2025000api.fda.gov
Image Navigation LtdJerusalem, IsraelManufacturer2December 16, 2005000api.fda.gov
Integra Pain ManagementWest Valley City, UT, United StatesManufacturer, Repackager or relabeler2December 6, 2016000api.fda.gov
Koh Young Technology Inc.Yeoju Gyeonggi, South KoreaManufacturer2September 10, 2026000api.fda.gov
Medtronic Xomed, Inc.Jacksonville, FL, United StatesManufacturer2August 7, 2013010api.fda.gov
Navinetics Inc.Rochester, MN, United StatesSpecification developer2July 14, 2023010api.fda.gov
Northern Digital, Inc.WATERLOO Ontario, CanadaComplaint file establishment, Exporter to the US, Specification developer2July 14, 2010020api.fda.gov
Pajunk GMBH MedizintechnologieGEISINGEN Baden-Wurttemberg, GermanyComplaint file establishment, Contract manufacturer, Manufacturer2February 22, 2023000api.fda.gov
Stryker SpineAllendale, NJ, United StatesComplaint file establishment, Manufacturer, Specification developer2June 5, 2014000api.fda.gov
Zeta Surgical Inc.Boston, MA, United StatesManufacturer2May 1, 2026000api.fda.gov
Biomet, Inc.Warsaw, IN, United StatesManufacturer1March 21, 2006010api.fda.gov
Blue OrthoMeylan Isere, FranceManufacturer1July 13, 2016000api.fda.gov
Brain Navi Biotechnology Co., Ltd.Zhubei City Hsinchu(County), TaiwanManufacturer1May 23, 2025000api.fda.gov
Brain Science Tools BVDe Bilt Utrecht, NetherlandsComplaint file establishment, Manufacturer1April 6, 2020000api.fda.gov
Bayer Medical Care B.V.Maastricht Limburg, NetherlandsSpecification developer1September 4, 2025000api.fda.gov
Depuy Intl., Ltd.Leeds, United KingdomManufacturer, Specification developer1March 4, 2005000api.fda.gov
Eemagine Medical Imaging Solutions GMBHBerlin, GermanyManufacturer1April 8, 2022000api.fda.gov
FHC, IncGreenville, PA, United StatesManufacturer1February 12, 2010000api.fda.gov
GSB LLCNashville, TN, United StatesComplaint file establishment, Manufacturer1March 6, 2014000api.fda.gov
Hill-Rom De Mexico S De RL De CVAPODACA Nuevo Leon, MexicoManufacturer1June 12, 2000000api.fda.gov
Hill-Rom, Inc.Batesville, IN, United StatesManufacturer1June 12, 2000000api.fda.gov
Inomed Medizintechnik GMBHEMMENDINGEN Baden-Wurttemberg, GermanyManufacturer1May 17, 2001000api.fda.gov
Intravent Medical Partners LPBlue Bell, PA, United StatesSpecification developer1September 5, 2025000api.fda.gov
Karl Storz Se & Co KGTUTTLINGEN Baden-Wurttemberg, GermanySpecification developer1September 27, 2012000api.fda.gov
Localite GMBHBonn North Rhine-Westphalia, GermanyManufacturer1April 17, 2023000api.fda.gov
Linvatec CorporationLargo, FL, United StatesManufacturer1March 17, 1983000api.fda.gov
Materialise N.V.LEUVEN Vlaams Brabant, BelgiumManufacturer1March 27, 2012000api.fda.gov
Medacta International SACastel San Pietro Ticino, SwitzerlandComplaint file establishment, Manufacturer1March 31, 2010000api.fda.gov
Medacta International SARancate Ticino, SwitzerlandComplaint file establishment, Manufacturer1March 31, 2010000api.fda.gov
Medivis, Inc.New York, NY, United StatesManufacturer1October 21, 2025000api.fda.gov
Medtronic Powered Surgical SolutionsFort Worth, TX, United StatesManufacturer1November 1, 2019000api.fda.gov
Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United StatesManufacturer1June 12, 2000000api.fda.gov
Materialise Colombia S.A.SMedellin Antioquia, ColombiaManufacturer1March 27, 2012000api.fda.gov
Materialise Sdn BhdPetaling Jaya Selangor, MalaysiaManufacturer1March 27, 2012000api.fda.gov
Materialise USA, LLC.Plymouth, MI, United StatesManufacturer1March 27, 2012000api.fda.gov
Med-Surgical ServicesTucson, AZ, United StatesManufacturer1March 13, 2000000api.fda.gov
Medtronic (Changzhou) Medical Devices Technology Co., LtdChangzhou Jiangsu, ChinaManufacturer1June 2, 2005000api.fda.gov
Medtronic Grand RapidsGrand Rapids, MI, United StatesManufacturer1May 3, 2000000api.fda.gov
Neurodynamics, Inc.Manhattan, NY, United StatesSpecification developer1February 20, 1986000api.fda.gov
Phasor Health, LLCHouston, TX, United StatesComplaint file establishment, Manufacturer1July 9, 2025000api.fda.gov
PMT Corp.Chanhassen, MN, United StatesManufacturer1June 15, 1983000api.fda.gov
Renishaw MayfieldChassieu Rhone, FranceManufacturer1July 26, 2018000api.fda.gov
Sion Biotext Medical LtdSderot Southern, IsraelManufacturer1July 12, 2012000api.fda.gov
Smith & Nephew Inc.Oklahoma City, OK, United StatesManufacturer1June 22, 2004000api.fda.gov
Spinal Elements, Inc.Carlsbad, CA, United StatesComplaint file establishment, Manufacturer1April 7, 2005000api.fda.gov
Synthes GMBHZuchwil Solothurn, SwitzerlandSpecification developer1December 17, 2012000api.fda.gov
Sinovation (Beijing) Medical Technology Co., LtdBeijing, ChinaManufacturer1June 18, 2023000api.fda.gov
Synthes GMBHSelzach Solothurn, SwitzerlandManufacturer1December 17, 2012000api.fda.gov
Tonica Elektronik A/SFARUM Hovedstaden, DenmarkContract manufacturer, Manufacturer1March 17, 2023000api.fda.gov
3C-Medical Intelligence GmbHLandsberg am Lech Bavaria, GermanyContract manufacturer0000api.fda.gov
3D Instrumentation Sdn BhdBukit Mertajam Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
Alden Tool Company, Inc.Berlin, CT, United StatesContract manufacturer0000api.fda.gov
American Industrial Plastics, LLCDaytona Beach, FL, United StatesContract manufacturer0000api.fda.gov
American Manufacturing And EngineeringMontgomeryville, PA, United StatesContract manufacturer0000api.fda.gov
ARCH Medical Solutions - MemphisBartlett, TN, United StatesContract manufacturer0000api.fda.gov
ARCH Medical Solutions - MemphisLexington, TN, United StatesContract manufacturer0000api.fda.gov
ARCH Medical Solutions - Olive BranchOlive Branch, MS, United StatesContract manufacturer0000api.fda.gov
ARCH Medical Solutions - SeabrookSeabrook, NH, United StatesContract manufacturer0000api.fda.gov
ARCH-MedTorqueKenosha, WI, United StatesContract manufacturer0000api.fda.gov
Axial MedicalIvyland, PA, United StatesContract manufacturer0000api.fda.gov
Autocam MedicalMurfreesboro, TN, United StatesContract manufacturer0000api.fda.gov
Avalign Instruments & ImplantsFort Wayne, IN, United StatesContract manufacturer0000api.fda.gov
B & G MFG. Co.Hatfield, PA, United StatesContract manufacturer0000api.fda.gov
Bemotec GMBHSonnenbühl Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Branch Medical GroupEagleville, PA, United StatesContract manufacturer0000api.fda.gov
Branch Medical GroupLimerick, PA, United StatesContract manufacturer0000api.fda.gov
Bradshaw Medical Inc.Kenosha, WI, United StatesContract manufacturer0000api.fda.gov
C+a Tool Engineering, Inc.Churubusco, IN, United StatesContract manufacturer0000api.fda.gov
CEA Medical Manufacturing, Inc.Colorado Springs, CO, United StatesContract manufacturer0000api.fda.gov
Cenova ABMJOLBY Ostergotland, SwedenContract manufacturer0000api.fda.gov
Classic Wire Cut Company, Inc.Valencia, CA, United StatesContract manufacturer0000api.fda.gov
Culver Tool & EngineeringPlymouth, IN, United StatesContract manufacturer0000api.fda.gov
Depuy Spine, Inc.Raynham, MA, United StatesSpecification developer0000api.fda.gov
DHF Praezisionsmechanik GMBHTuntenhausen Bavaria, GermanyContract manufacturer0000api.fda.gov
Elos Medtech Timmersdala ABTIMMERSDALA Vastra Gotaland, SwedenContract manufacturer0000api.fda.gov
Engineering CPR Inc.mississauga Ontario, CanadaContract manufacturer0000api.fda.gov
Eurofins Inpac Medizintechnik GMBHBirkenfeld Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Elite Medical, LLCBartlett, TN, United StatesContract manufacturer0000api.fda.gov
Elite Medical, LLCFlorence, AL, United StatesContract manufacturer0000api.fda.gov
Engineered Medical Systems, LLCBartlett, TN, United StatesContract manufacturer0000api.fda.gov
Euclide CareAixe Sur Vienne Haute-Vienne, FranceContract manufacturer0000api.fda.gov
Exo-s Saint-Damien Inc.St-Damien de Buckland Quebec, CanadaContract manufacturer0000api.fda.gov
Ferry Machine CorporationOakland, NJ, United StatesContract manufacturer0000api.fda.gov
First Article IncSouderton, PA, United StatesContract manufacturer0000api.fda.gov
Five Star Manufacturing, Inc.New Bedford, MA, United StatesContract manufacturer0000api.fda.gov
Flex-Cell Precision, Inc.Lancaster, PA, United StatesContract manufacturer0000api.fda.gov
Flexbar Machine Corp.Islandia, NY, United StatesContract manufacturer0000api.fda.gov
Freyer GMBH & Co. KGTuningen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Friedrich Daniels GMBHSOLINGEN North Rhine-Westphalia, GermanyContract manufacturer0000api.fda.gov
Ferry Machine CorporationLittle Ferry, NJ, United StatesContract manufacturer0000api.fda.gov
Gauthier Biomedical, Inc.Grafton, WI, United StatesContract manufacturer0000api.fda.gov
Gebruder Renggli, AGSchaffhausen, SwitzerlandContract manufacturer0000api.fda.gov
Globus Medical, Inc.Audubon, PA, United StatesManufacturer0010api.fda.gov
Globus Medical, Inc.Methuen, MA, United StatesManufacturer0000api.fda.gov
Globus Medical, Inc.Memphis, TN, United StatesManufacturer0000api.fda.gov
Harwood Design, Inc.Bristol, PA, United StatesContract manufacturer0000api.fda.gov
Highridge Medical, LLCWestminster, CO, United StatesSpecification developer0000api.fda.gov
Hipp Medical AGRenquishausen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
I-Tek Medical, Inc.White Bear Lake, MN, United StatesContract manufacturer0000api.fda.gov
Iimed Medical Mexicana S. De R.L. De C.V.Reynosa Tamaulipas, MexicoContract manufacturer0000api.fda.gov
Incipio DevicesHuntington, IN, United StatesContract manufacturer0000api.fda.gov
Insert Molding Solutions, Inc.Cumming, GA, United StatesContract manufacturer0000api.fda.gov
Instru-Med TechnologiesWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
J & J Precision Technologies, LLCLititz, PA, United StatesContract manufacturer0000api.fda.gov
J&B Precision, Inc.Cordova, TN, United StatesContract manufacturer0000api.fda.gov
JAKUTEC MEDIZINTECHNIK GMBH & Co. KGLIPTINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Jatex, Inc.Nappanee, IN, United StatesContract manufacturer0000api.fda.gov
Josef Frech GMBH & Co. KGKonigsheim Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Jabil Inc. (Monument)Monument, CO, United StatesContract manufacturer0000api.fda.gov
Jabil Switzerland Manufacturing GmbH (Balsthal)Balsthal Solothurn, SwitzerlandContract manufacturer0000api.fda.gov
Jabil Switzerland Manufacturing GmbH (Hagendorf)Hagendorf Solothurn, SwitzerlandContract manufacturer0000api.fda.gov
Karl Storz Se & Co. KGTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Karl Storz Se & Co. KGNEUHAUSEN OBECK Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
KLS Martin SE & Co. KGMuhlheim/Donau Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
KM HealthcareCheorwon-gun, Gangwon-do, South KoreaContract manufacturer0000api.fda.gov
Life Science Outsourcing, Inc.Brea, CA, United StatesContract manufacturer0000api.fda.gov
Lowell,inc.Brooklyn Park, MN, United StatesContract manufacturer0000api.fda.gov
Mackay Manufacturing, Inc.Spokane Valley, WA, United StatesContract manufacturer0000api.fda.gov
Magnus Medical Inc.Burlingame, CA, United StatesManufacturer0000api.fda.gov
Maitland EngineeringSouth Bend, IN, United StatesContract manufacturer0000api.fda.gov
Matrix Machining Technologies, Inc.Memphis, TN, United StatesContract manufacturer0000api.fda.gov
Mclean Medical & ScientificSaint Paul, MN, United StatesContract manufacturer0000api.fda.gov
Medos International SarlLe Locle Neuchatel, SwitzerlandSpecification developer0000api.fda.gov
Millstone Medical Outsourcing LLC.Fall River, MA, United StatesContract manufacturer0000api.fda.gov
Monteris Medical CorpMinnetonka, MN, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
MSK Precision Products, Inc.Tamarac, FL, United StatesContract manufacturer0000api.fda.gov
Multisource Manufacturing LLCLongmont, CO, United StatesContract manufacturer0000api.fda.gov
Nexstim PlcHelsinki Uusimaa, FinlandManufacturer0000api.fda.gov
NPA de Mexico S.de R.L. de C.V.Tijuana Baja California, MexicoContract manufacturer0000api.fda.gov
Nse-AutomatechGranby Quebec, CanadaContract manufacturer0000api.fda.gov
Nucletron B.V.VEENENDAAL Utrecht, NetherlandsContract manufacturer0000api.fda.gov
Nuvasive, Inc.Guaynabo, PR, United StatesManufacturer0000api.fda.gov
Nuvasive, Inc.San Diego, CA, United StatesManufacturer0000api.fda.gov
Neuromedex GmbHHamburg Schleswig-Holstein, GermanyContract manufacturer0000api.fda.gov
NextPhase Medical Devices LLCRochester, NH, United StatesContract manufacturer0000api.fda.gov
Onyx Healthcare Usa, Inc.Orange, CA, United StatesManufacturer0000api.fda.gov
Onyx Medical LLCMemphis, TN, United StatesContract manufacturer0000api.fda.gov
Orchid UniqueBridgeport, MI, United StatesContract manufacturer0000api.fda.gov
Olive Branch Distribution CenterOlive Branch, MS, United StatesContract manufacturer0000api.fda.gov
Orchid Orthopedic Solutions Alabama LLCArab, AL, United StatesContract manufacturer0000api.fda.gov
Packaging Compliance Medical, LLCKentwood, MI, United StatesContract manufacturer0000api.fda.gov
Paragon Medical, Inc.Pierceton, IN, United StatesContract manufacturer0000api.fda.gov
Plexus Corp.Buffalo Grove, IL, United StatesContract manufacturer0000api.fda.gov
Paragon Medical Device (Changzhou) Co., Ltd.Changzhou Jiangsu, ChinaContract manufacturer0000api.fda.gov
Quality Tech Services, LLCBloomington, MN, United StatesContract manufacturer0000api.fda.gov
Quality Tech Services, LLCShakopee, MN, United StatesContract manufacturer0000api.fda.gov
RAUMEDIC - Werk ZwoenitzZwoenitz Saxony, GermanyContract manufacturer0000api.fda.gov
Remington Medical, Inc.Alpharetta, GA, United StatesContract manufacturer0000api.fda.gov
Renishaw Neuro Solutions LtdWotton-under-Edge Gloucestershire, United KingdomContract manufacturer0000api.fda.gov
Remington Medical, Inc.Alpharetta, GA, United StatesContract manufacturer0000api.fda.gov
Sanmina- Sci Israel Medical Systems Ltd.Maalot-Tarshiha Northern, IsraelContract manufacturer0000api.fda.gov
Shandong Weigao Orthopaedic Device Co.,ltdweihai Shandong, ChinaContract manufacturer0000api.fda.gov
SimagecROUSSET CEDEX Bouches-du-Rhone, FranceContract manufacturer0000api.fda.gov
Starfish Product EngineeringToronto Ontario, CanadaContract manufacturer0000api.fda.gov
Straits Orthopaedics (MFG) Sdn BhdSimpang Ampat Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
Straits Orthopaedics (MFG) Sdn BhdPerai Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
Straits Orthopaedics (MFG) Sdn BhdBandar Cassia Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
Structure Medical, LLC.Naples, FL, United StatesContract manufacturer0000api.fda.gov
STRYKER GmbHSELZACH Solothurn, SwitzerlandContract manufacturer0000api.fda.gov
Stryker SpineCESTAS Nouvelle-Aquitaine, FranceContract manufacturer0000api.fda.gov
Surgical Technologies, Inc.St. Paul, MN, United StatesContract manufacturer0000api.fda.gov
Symmetry Medical Manufacturing IncClaypool, IN, United StatesContract manufacturer0000api.fda.gov
Symmetry Medical Manufacturing Inc.Warsaw, IN, United StatesContract manufacturer0000api.fda.gov
Symmetry Medical Polyvac SASWAMBRECHIES Nord, FranceContract manufacturer0000api.fda.gov
Spartronics Watertown LLCWatertown, SD, United StatesContract manufacturer0000api.fda.gov
Syrma Johari MedTech LimitedJodhpur Rajasthan, IndiaContract manufacturer0000api.fda.gov
Tamuz F.T.K. SolutionsAfula Northern, IsraelContract manufacturer0000api.fda.gov
Turner Medical Inc.Athens, AL, United StatesContract manufacturer0000api.fda.gov
Unimed S.A.ECUBLENS Vaud, SwitzerlandContract manufacturer0000api.fda.gov
Valid Co., Ltd.Hwaseong Gyeonggi, South KoreaContract manufacturer0000api.fda.gov
Victoria Precision Inc.Trevose, PA, United StatesContract manufacturer0000api.fda.gov
Zdhitech Co., Ltd.Hwaseong Gyeonggi, South KoreaContract manufacturer0000api.fda.gov
Zimmer GMBHWINTERTHUR Zurich, SwitzerlandContract manufacturer0000api.fda.gov

Updated October 15, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.