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.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Product code
- HAW
- Device class
- 2
- Regulation
- 882.4560
- Medical specialty
- Neurology
Makers by country
| Country | Makers |
|---|---|
| United States | 110 |
| Germany | 22 |
| Switzerland | 11 |
| Canada | 9 |
| France | 7 |
| Israel | 5 |
| Malaysia | 5 |
| South Korea | 4 |
| China | 4 |
| Sweden | 3 |
| Netherlands | 3 |
| Mexico | 3 |
| United Kingdom | 2 |
| Taiwan | 1 |
| Belgium | 1 |
| Colombia | 1 |
| Denmark | 1 |
| Finland | 1 |
| India | 1 |
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.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Medtronic Navigation, Inc. | Lafayette, CO, United States | Manufacturer, Repackager or relabeler, Specification developer | 41 | March 26, 2026 | 0 | 35 | 7 | api.fda.gov |
| Brainlab Se | Munich Bavaria, Germany | Exporter to the US, Manufacturer | 17 | January 28, 2025 | 0 | 9 | 2 | api.fda.gov |
| Stryker Leibinger GMBH & Co. KG | FREIBURG Baden-Wurttemberg, Germany | Complaint file establishment, Manufacturer, Specification developer | 12 | February 16, 2023 | 0 | 1 | 0 | api.fda.gov |
| FHC, Inc. | Bowdoin, ME, United States | Complaint file establishment, Manufacturer | 9 | July 26, 2012 | 0 | 6 | 1 | api.fda.gov |
| Zimmer Cas | Montreal, Quebec, Canada | Manufacturer | 9 | July 20, 2007 | 0 | 4 | 0 | api.fda.gov |
| ClearPoint Neuro Inc. | Carlsbad, CA, United States | Manufacturer | 7 | January 24, 2025 | 0 | 0 | 0 | api.fda.gov |
| Integra Lifesciences Corporation | Cincinnati, OH, United States | Manufacturer | 5 | December 6, 2016 | 0 | 0 | 0 | api.fda.gov |
| Smith & Nephew, Inc. | Memphis, TN, United States | Manufacturer | 5 | January 14, 2005 | 0 | 0 | 0 | api.fda.gov |
| Smith & Nephew, Inc. | Memphis, TN, United States | Manufacturer | 5 | January 14, 2005 | 0 | 0 | 0 | api.fda.gov |
| Synaptive Medical Inc | Mississauga Ontario, Canada | Exporter to the US, Manufacturer | 5 | July 14, 2019 | 0 | 2 | 1 | api.fda.gov |
| 7D Surgical ULC | Toronto Ontario, Canada | Manufacturer, Specification developer | 4 | December 27, 2024 | 0 | 0 | 0 | api.fda.gov |
| Aesculap AG | TUTTLINGEN, DONAU Baden-Wurttemberg, Germany | Complaint file establishment, Manufacturer | 4 | May 23, 2008 | 0 | 0 | 0 | api.fda.gov |
| Izi Medical Products LLC | Owings Mills, MD, United States | Manufacturer, Repackager or relabeler | 4 | April 13, 2015 | 0 | 0 | 0 | api.fda.gov |
| COMPASS International Innovations, Inc. | Rochester, MN, United States | Manufacturer, Specification developer | 3 | August 19, 1997 | 0 | 0 | 0 | api.fda.gov |
| Depuy Orthopaedics, Inc. | Warsaw, IN, United States | Manufacturer, Repackager or relabeler, Specification developer | 3 | May 23, 2007 | 0 | 0 | 0 | api.fda.gov |
| Depuy Orthopaedics, Inc. | Raynham, MA, United States | Manufacturer, Specification developer | 3 | May 23, 2007 | 0 | 0 | 0 | api.fda.gov |
| Elekta Solutions AB | Stockholm, Sweden | Exporter to the US, Manufacturer, Specification developer | 3 | August 5, 2026 | 0 | 0 | 0 | api.fda.gov |
| Mazor Robotics Ltd. | Caesarea Haifa, Israel | Manufacturer | 3 | July 12, 2012 | 0 | 1 | 0 | api.fda.gov |
| Medtech SAS | MAUGUIO Occitanie, France | Manufacturer | 3 | July 20, 2023 | 0 | 4 | 2 | api.fda.gov |
| Smith & Nephew, Inc. | Memphis, TN, United States | Manufacturer | 3 | January 14, 2005 | 0 | 0 | 0 | api.fda.gov |
| Ad-Tech Medical Instrument Corp. | Oak Creek, WI, United States | Manufacturer | 2 | April 24, 2012 | 0 | 0 | 0 | api.fda.gov |
| ClaroNav Inc. | Toronto Ontario, Canada | Manufacturer | 2 | February 5, 2025 | 0 | 0 | 0 | api.fda.gov |
| Image Navigation Ltd | Jerusalem, Israel | Manufacturer | 2 | December 16, 2005 | 0 | 0 | 0 | api.fda.gov |
| Integra Pain Management | West Valley City, UT, United States | Manufacturer, Repackager or relabeler | 2 | December 6, 2016 | 0 | 0 | 0 | api.fda.gov |
| Koh Young Technology Inc. | Yeoju Gyeonggi, South Korea | Manufacturer | 2 | September 10, 2026 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Xomed, Inc. | Jacksonville, FL, United States | Manufacturer | 2 | August 7, 2013 | 0 | 1 | 0 | api.fda.gov |
| Navinetics Inc. | Rochester, MN, United States | Specification developer | 2 | July 14, 2023 | 0 | 1 | 0 | api.fda.gov |
| Northern Digital, Inc. | WATERLOO Ontario, Canada | Complaint file establishment, Exporter to the US, Specification developer | 2 | July 14, 2010 | 0 | 2 | 0 | api.fda.gov |
| Pajunk GMBH Medizintechnologie | GEISINGEN Baden-Wurttemberg, Germany | Complaint file establishment, Contract manufacturer, Manufacturer | 2 | February 22, 2023 | 0 | 0 | 0 | api.fda.gov |
| Stryker Spine | Allendale, NJ, United States | Complaint file establishment, Manufacturer, Specification developer | 2 | June 5, 2014 | 0 | 0 | 0 | api.fda.gov |
| Zeta Surgical Inc. | Boston, MA, United States | Manufacturer | 2 | May 1, 2026 | 0 | 0 | 0 | api.fda.gov |
| Biomet, Inc. | Warsaw, IN, United States | Manufacturer | 1 | March 21, 2006 | 0 | 1 | 0 | api.fda.gov |
| Blue Ortho | Meylan Isere, France | Manufacturer | 1 | July 13, 2016 | 0 | 0 | 0 | api.fda.gov |
| Brain Navi Biotechnology Co., Ltd. | Zhubei City Hsinchu(County), Taiwan | Manufacturer | 1 | May 23, 2025 | 0 | 0 | 0 | api.fda.gov |
| Brain Science Tools BV | De Bilt Utrecht, Netherlands | Complaint file establishment, Manufacturer | 1 | April 6, 2020 | 0 | 0 | 0 | api.fda.gov |
| Bayer Medical Care B.V. | Maastricht Limburg, Netherlands | Specification developer | 1 | September 4, 2025 | 0 | 0 | 0 | api.fda.gov |
| Depuy Intl., Ltd. | Leeds, United Kingdom | Manufacturer, Specification developer | 1 | March 4, 2005 | 0 | 0 | 0 | api.fda.gov |
| Eemagine Medical Imaging Solutions GMBH | Berlin, Germany | Manufacturer | 1 | April 8, 2022 | 0 | 0 | 0 | api.fda.gov |
| FHC, Inc | Greenville, PA, United States | Manufacturer | 1 | February 12, 2010 | 0 | 0 | 0 | api.fda.gov |
| GSB LLC | Nashville, TN, United States | Complaint file establishment, Manufacturer | 1 | March 6, 2014 | 0 | 0 | 0 | api.fda.gov |
| Hill-Rom De Mexico S De RL De CV | APODACA Nuevo Leon, Mexico | Manufacturer | 1 | June 12, 2000 | 0 | 0 | 0 | api.fda.gov |
| Hill-Rom, Inc. | Batesville, IN, United States | Manufacturer | 1 | June 12, 2000 | 0 | 0 | 0 | api.fda.gov |
| Inomed Medizintechnik GMBH | EMMENDINGEN Baden-Wurttemberg, Germany | Manufacturer | 1 | May 17, 2001 | 0 | 0 | 0 | api.fda.gov |
| Intravent Medical Partners LP | Blue Bell, PA, United States | Specification developer | 1 | September 5, 2025 | 0 | 0 | 0 | api.fda.gov |
| Karl Storz Se & Co KG | TUTTLINGEN Baden-Wurttemberg, Germany | Specification developer | 1 | September 27, 2012 | 0 | 0 | 0 | api.fda.gov |
| Localite GMBH | Bonn North Rhine-Westphalia, Germany | Manufacturer | 1 | April 17, 2023 | 0 | 0 | 0 | api.fda.gov |
| Linvatec Corporation | Largo, FL, United States | Manufacturer | 1 | March 17, 1983 | 0 | 0 | 0 | api.fda.gov |
| Materialise N.V. | LEUVEN Vlaams Brabant, Belgium | Manufacturer | 1 | March 27, 2012 | 0 | 0 | 0 | api.fda.gov |
| Medacta International SA | Castel San Pietro Ticino, Switzerland | Complaint file establishment, Manufacturer | 1 | March 31, 2010 | 0 | 0 | 0 | api.fda.gov |
| Medacta International SA | Rancate Ticino, Switzerland | Complaint file establishment, Manufacturer | 1 | March 31, 2010 | 0 | 0 | 0 | api.fda.gov |
| Medivis, Inc. | New York, NY, United States | Manufacturer | 1 | October 21, 2025 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Powered Surgical Solutions | Fort Worth, TX, United States | Manufacturer | 1 | November 1, 2019 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Sofamor Danek Usa, Inc. | Memphis, TN, United States | Manufacturer | 1 | June 12, 2000 | 0 | 0 | 0 | api.fda.gov |
| Materialise Colombia S.A.S | Medellin Antioquia, Colombia | Manufacturer | 1 | March 27, 2012 | 0 | 0 | 0 | api.fda.gov |
| Materialise Sdn Bhd | Petaling Jaya Selangor, Malaysia | Manufacturer | 1 | March 27, 2012 | 0 | 0 | 0 | api.fda.gov |
| Materialise USA, LLC. | Plymouth, MI, United States | Manufacturer | 1 | March 27, 2012 | 0 | 0 | 0 | api.fda.gov |
| Med-Surgical Services | Tucson, AZ, United States | Manufacturer | 1 | March 13, 2000 | 0 | 0 | 0 | api.fda.gov |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd | Changzhou Jiangsu, China | Manufacturer | 1 | June 2, 2005 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Grand Rapids | Grand Rapids, MI, United States | Manufacturer | 1 | May 3, 2000 | 0 | 0 | 0 | api.fda.gov |
| Neurodynamics, Inc. | Manhattan, NY, United States | Specification developer | 1 | February 20, 1986 | 0 | 0 | 0 | api.fda.gov |
| Phasor Health, LLC | Houston, TX, United States | Complaint file establishment, Manufacturer | 1 | July 9, 2025 | 0 | 0 | 0 | api.fda.gov |
| PMT Corp. | Chanhassen, MN, United States | Manufacturer | 1 | June 15, 1983 | 0 | 0 | 0 | api.fda.gov |
| Renishaw Mayfield | Chassieu Rhone, France | Manufacturer | 1 | July 26, 2018 | 0 | 0 | 0 | api.fda.gov |
| Sion Biotext Medical Ltd | Sderot Southern, Israel | Manufacturer | 1 | July 12, 2012 | 0 | 0 | 0 | api.fda.gov |
| Smith & Nephew Inc. | Oklahoma City, OK, United States | Manufacturer | 1 | June 22, 2004 | 0 | 0 | 0 | api.fda.gov |
| Spinal Elements, Inc. | Carlsbad, CA, United States | Complaint file establishment, Manufacturer | 1 | April 7, 2005 | 0 | 0 | 0 | api.fda.gov |
| Synthes GMBH | Zuchwil Solothurn, Switzerland | Specification developer | 1 | December 17, 2012 | 0 | 0 | 0 | api.fda.gov |
| Sinovation (Beijing) Medical Technology Co., Ltd | Beijing, China | Manufacturer | 1 | June 18, 2023 | 0 | 0 | 0 | api.fda.gov |
| Synthes GMBH | Selzach Solothurn, Switzerland | Manufacturer | 1 | December 17, 2012 | 0 | 0 | 0 | api.fda.gov |
| Tonica Elektronik A/S | FARUM Hovedstaden, Denmark | Contract manufacturer, Manufacturer | 1 | March 17, 2023 | 0 | 0 | 0 | api.fda.gov |
| 3C-Medical Intelligence GmbH | Landsberg am Lech Bavaria, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| 3D Instrumentation Sdn Bhd | Bukit Mertajam Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alden Tool Company, Inc. | Berlin, CT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| American Industrial Plastics, LLC | Daytona Beach, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| American Manufacturing And Engineering | Montgomeryville, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ARCH Medical Solutions - Memphis | Bartlett, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ARCH Medical Solutions - Memphis | Lexington, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ARCH Medical Solutions - Olive Branch | Olive Branch, MS, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ARCH Medical Solutions - Seabrook | Seabrook, NH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ARCH-MedTorque | Kenosha, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Axial Medical | Ivyland, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Autocam Medical | Murfreesboro, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Avalign Instruments & Implants | Fort Wayne, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| B & G MFG. Co. | Hatfield, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bemotec GMBH | Sonnenbühl Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Branch Medical Group | Eagleville, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Branch Medical Group | Limerick, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bradshaw Medical Inc. | Kenosha, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| C+a Tool Engineering, Inc. | Churubusco, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CEA Medical Manufacturing, Inc. | Colorado Springs, CO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cenova AB | MJOLBY Ostergotland, Sweden | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Classic Wire Cut Company, Inc. | Valencia, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Culver Tool & Engineering | Plymouth, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Depuy Spine, Inc. | Raynham, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DHF Praezisionsmechanik GMBH | Tuntenhausen Bavaria, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Elos Medtech Timmersdala AB | TIMMERSDALA Vastra Gotaland, Sweden | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Engineering CPR Inc. | mississauga Ontario, Canada | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eurofins Inpac Medizintechnik GMBH | Birkenfeld Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Elite Medical, LLC | Bartlett, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Elite Medical, LLC | Florence, AL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Engineered Medical Systems, LLC | Bartlett, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Euclide Care | Aixe Sur Vienne Haute-Vienne, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Exo-s Saint-Damien Inc. | St-Damien de Buckland Quebec, Canada | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ferry Machine Corporation | Oakland, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| First Article Inc | Souderton, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Five Star Manufacturing, Inc. | New Bedford, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Flex-Cell Precision, Inc. | Lancaster, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Flexbar Machine Corp. | Islandia, NY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Freyer GMBH & Co. KG | Tuningen Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Friedrich Daniels GMBH | SOLINGEN North Rhine-Westphalia, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ferry Machine Corporation | Little Ferry, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gauthier Biomedical, Inc. | Grafton, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gebruder Renggli, AG | Schaffhausen, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Globus Medical, Inc. | Audubon, PA, United States | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Globus Medical, Inc. | Methuen, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Globus Medical, Inc. | Memphis, TN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Harwood Design, Inc. | Bristol, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Highridge Medical, LLC | Westminster, CO, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hipp Medical AG | Renquishausen Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| I-Tek Medical, Inc. | White Bear Lake, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Iimed Medical Mexicana S. De R.L. De C.V. | Reynosa Tamaulipas, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Incipio Devices | Huntington, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Insert Molding Solutions, Inc. | Cumming, GA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Instru-Med Technologies | Warsaw, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| J & J Precision Technologies, LLC | Lititz, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| J&B Precision, Inc. | Cordova, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| JAKUTEC MEDIZINTECHNIK GMBH & Co. KG | LIPTINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jatex, Inc. | Nappanee, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Josef Frech GMBH & Co. KG | Konigsheim Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Inc. (Monument) | Monument, CO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Switzerland Manufacturing GmbH (Balsthal) | Balsthal Solothurn, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Switzerland Manufacturing GmbH (Hagendorf) | Hagendorf Solothurn, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Karl Storz Se & Co. KG | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Karl Storz Se & Co. KG | NEUHAUSEN OBECK Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| KLS Martin SE & Co. KG | Muhlheim/Donau Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| KM Healthcare | Cheorwon-gun, Gangwon-do, South Korea | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Life Science Outsourcing, Inc. | Brea, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lowell,inc. | Brooklyn Park, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mackay Manufacturing, Inc. | Spokane Valley, WA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Magnus Medical Inc. | Burlingame, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Maitland Engineering | South Bend, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Matrix Machining Technologies, Inc. | Memphis, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mclean Medical & Scientific | Saint Paul, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medos International Sarl | Le Locle Neuchatel, Switzerland | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Millstone Medical Outsourcing LLC. | Fall River, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Monteris Medical Corp | Minnetonka, MN, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MSK Precision Products, Inc. | Tamarac, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Multisource Manufacturing LLC | Longmont, CO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nexstim Plc | Helsinki Uusimaa, Finland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| NPA de Mexico S.de R.L. de C.V. | Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nse-Automatech | Granby Quebec, Canada | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nucletron B.V. | VEENENDAAL Utrecht, Netherlands | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nuvasive, Inc. | Guaynabo, PR, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nuvasive, Inc. | San Diego, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Neuromedex GmbH | Hamburg Schleswig-Holstein, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| NextPhase Medical Devices LLC | Rochester, NH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Onyx Healthcare Usa, Inc. | Orange, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Onyx Medical LLC | Memphis, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orchid Unique | Bridgeport, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Olive Branch Distribution Center | Olive Branch, MS, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orchid Orthopedic Solutions Alabama LLC | Arab, AL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Packaging Compliance Medical, LLC | Kentwood, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paragon Medical, Inc. | Pierceton, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Plexus Corp. | Buffalo Grove, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quality Tech Services, LLC | Bloomington, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quality Tech Services, LLC | Shakopee, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RAUMEDIC - Werk Zwoenitz | Zwoenitz Saxony, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Remington Medical, Inc. | Alpharetta, GA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Renishaw Neuro Solutions Ltd | Wotton-under-Edge Gloucestershire, United Kingdom | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Remington Medical, Inc. | Alpharetta, GA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sanmina- Sci Israel Medical Systems Ltd. | Maalot-Tarshiha Northern, Israel | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shandong Weigao Orthopaedic Device Co.,ltd | weihai Shandong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Simagec | ROUSSET CEDEX Bouches-du-Rhone, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Starfish Product Engineering | Toronto Ontario, Canada | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Straits Orthopaedics (MFG) Sdn Bhd | Simpang Ampat Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Straits Orthopaedics (MFG) Sdn Bhd | Perai Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Straits Orthopaedics (MFG) Sdn Bhd | Bandar Cassia Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Structure Medical, LLC. | Naples, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| STRYKER GmbH | SELZACH Solothurn, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stryker Spine | CESTAS Nouvelle-Aquitaine, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Surgical Technologies, Inc. | St. Paul, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Symmetry Medical Manufacturing Inc | Claypool, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Symmetry Medical Manufacturing Inc. | Warsaw, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Symmetry Medical Polyvac SAS | WAMBRECHIES Nord, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Spartronics Watertown LLC | Watertown, SD, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Syrma Johari MedTech Limited | Jodhpur Rajasthan, India | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tamuz F.T.K. Solutions | Afula Northern, Israel | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Turner Medical Inc. | Athens, AL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Unimed S.A. | ECUBLENS Vaud, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Valid Co., Ltd. | Hwaseong Gyeonggi, South Korea | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Victoria Precision Inc. | Trevose, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zdhitech Co., Ltd. | Hwaseong Gyeonggi, South Korea | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zimmer GMBH | WINTERTHUR Zurich, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.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.