Data / Medical devices / Arthroscope
Arthroscope (HRX): 225 FDA-registered makers in 24 countries
225 establishments in 24 countries are registered with the FDA to make Arthroscope (product code HRX, Class 2, 21 CFR 888.1100). 97 of them have a 510(k) clearance or PMA approval on file and 19 have a recall event. The FDA has issued 685 510(k) clearances under this code, the latest on October 14, 2026, and lists 52 recall events (0 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
- HRX
- Device class
- 2
- Regulation
- 888.1100
- Medical specialty
- Orthopedic
Makers by country
| Country | Makers |
|---|---|
| United States | 126 |
| Germany | 29 |
| China | 12 |
| Switzerland | 8 |
| Mexico | 8 |
| South Korea | 6 |
| Italy | 6 |
| Costa Rica | 5 |
| Malaysia | 4 |
| Dominican Republic | 3 |
| France | 2 |
| Taiwan | 2 |
| United Kingdom | 2 |
| Thailand | 2 |
| Czechia | 1 |
| Hong Kong | 1 |
| Malta | 1 |
| Nicaragua | 1 |
| Honduras | 1 |
| Canada | 1 |
| Poland | 1 |
| Hungary | 1 |
| Ireland | 1 |
| Bulgaria | 1 |
Makers of Arthroscope
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 |
|---|---|---|---|---|---|---|---|---|
| Karl Storz Endoscopy-America, Inc. | Auburn, MA, United States | Contract manufacturer, Repackager or relabeler | 35 | August 26, 2026 | 0 | 0 | 0 | api.fda.gov |
| Smith & Nephew Inc. | Andover, MA, United States | Manufacturer, Specification developer | 30 | July 20, 2020 | 0 | 3 | 0 | api.fda.gov |
| Karl Storz Se & Co KG | TUTTLINGEN Baden-Wurttemberg, Germany | Specification developer | 23 | August 26, 2026 | 0 | 0 | 0 | api.fda.gov |
| Linvatec Corporation | Largo, FL, United States | Complaint file establishment, Manufacturer, Specification developer | 21 | November 14, 2018 | 0 | 5 | 0 | api.fda.gov |
| Smith & Nephew Inc. | Mansfield, MA, United States | Manufacturer | 19 | May 20, 1998 | 0 | 1 | 0 | api.fda.gov |
| Smith & Nephew Inc. | Oklahoma City, OK, United States | Manufacturer, Repackager or relabeler | 18 | July 20, 2020 | 0 | 0 | 0 | api.fda.gov |
| DePuy Mitek, Inc. | Raynham, MA, United States | Specification developer | 15 | February 26, 2024 | 0 | 2 | 0 | api.fda.gov |
| Medos International Sarl | Le Locle Neuchatel, Switzerland | Specification developer | 12 | October 18, 2022 | 0 | 0 | 0 | api.fda.gov |
| Stryker Endoscopy | San Jose, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 12 | December 1, 2020 | 0 | 7 | 0 | api.fda.gov |
| Arthrex, Inc. | Naples, FL, United States | Specification developer | 10 | May 16, 2025 | 0 | 0 | 0 | api.fda.gov |
| Arthrocare Corporation | Coyol Alajuela, Costa Rica | Manufacturer | 9 | June 28, 2001 | 0 | 0 | 0 | api.fda.gov |
| Richard Wolf GMBH | KNITTLINGEN Baden-Wurttemberg, Germany | Manufacturer | 9 | June 27, 2008 | 0 | 1 | 0 | api.fda.gov |
| Medtronic Sofamor Danek Usa, Inc. | Memphis, TN, United States | Specification developer | 8 | July 23, 2015 | 0 | 1 | 0 | api.fda.gov |
| Stryker Instruments | Portage, MI, United States | Complaint file establishment, Specification developer | 7 | May 6, 2024 | 0 | 0 | 0 | api.fda.gov |
| Arthrex GmbH | Munich Bavaria, Germany | Exporter to the US, Specification developer | 6 | August 3, 2009 | 0 | 0 | 0 | api.fda.gov |
| Stryker Sustainability Solutions Lakeland | Lakeland, FL, United States | Reprocessor | 6 | November 9, 2001 | 0 | 1 | 0 | api.fda.gov |
| Biomet, Inc. | Warsaw, IN, United States | Manufacturer | 5 | January 14, 2008 | 0 | 2 | 0 | api.fda.gov |
| Medtronic Sofamor Danek Usa, Inc. | Memphis, TN, United States | Manufacturer | 5 | January 24, 2011 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Mexico S. de R.L. de CV | Tijuana Baja California, Mexico | Manufacturer | 5 | July 23, 2015 | 0 | 0 | 0 | api.fda.gov |
| Stryker Tijuana Operations | Tijuana Baja California, Mexico | Reprocessor | 5 | November 8, 2001 | 0 | 0 | 0 | api.fda.gov |
| Hydrocision, Inc. | Billerica, MA, United States | Repackager or relabeler, Specification developer | 4 | April 16, 2020 | 0 | 1 | 0 | api.fda.gov |
| Highridge Medical, LLC | Westminster, CO, United States | Specification developer | 4 | June 6, 2006 | 0 | 0 | 0 | api.fda.gov |
| Microaire Surgical Instruments LLC | Charlottesville, VA, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 4 | February 2, 2023 | 0 | 2 | 0 | api.fda.gov |
| Stryker Puerto Rico, LLC. | Arroyo, PR, United States | Contract manufacturer, Manufacturer, Repackager or relabeler | 4 | December 21, 2018 | 0 | 0 | 0 | api.fda.gov |
| Trice Medical | Malvern, PA, United States | Complaint file establishment, Manufacturer, Specification developer | 4 | September 15, 2021 | 0 | 0 | 0 | api.fda.gov |
| Clarus Medical, LLC. | Minneapolis, MN, United States | Manufacturer | 3 | April 25, 2024 | 0 | 0 | 0 | api.fda.gov |
| Instrumed International Inc dba Avalign German Specialty Instruments | Schaumburg, IL, United States | Contract manufacturer, Repackager or relabeler | 3 | July 31, 1997 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Xomed, Inc. | Jacksonville, FL, United States | Manufacturer | 3 | November 10, 1999 | 0 | 0 | 0 | api.fda.gov |
| Novanta Medical S.R.O. | Prelouc Pardubicky Kraj, Czechia | Manufacturer | 3 | December 5, 2025 | 0 | 0 | 0 | api.fda.gov |
| Novanta Medical GmbH | LUDWIGSSTADT Bavaria, Germany | Manufacturer | 3 | December 5, 2025 | 0 | 1 | 0 | api.fda.gov |
| Novanta Medical GmbH | Berlin, Germany | Specification developer | 3 | December 5, 2025 | 0 | 0 | 0 | api.fda.gov |
| Warsaw Orthopedic, Inc. | Warsaw, IN, United States | Manufacturer, Repackager or relabeler | 3 | November 24, 2000 | 0 | 1 | 0 | api.fda.gov |
| Arthrex Logistic Center | Fort Myers, FL, United States | Manufacturer | 2 | October 10, 1996 | 0 | 0 | 0 | api.fda.gov |
| Douglas Medical Products, Inc | Mundelein, IL, United States | Complaint file establishment, Specification developer | 2 | September 30, 1994 | 0 | 0 | 0 | api.fda.gov |
| Elliquence LLC | Baldwin, NY, United States | Manufacturer | 2 | June 11, 2018 | 0 | 0 | 0 | api.fda.gov |
| Eberle GmbH & Co. KG | WURMBERG Baden-Wurttemberg, Germany | Contract manufacturer, Manufacturer | 2 | September 29, 2010 | 0 | 0 | 0 | api.fda.gov |
| Globus Medical, Inc. | Audubon, PA, United States | Manufacturer | 2 | April 5, 2019 | 0 | 0 | 0 | api.fda.gov |
| Hand Biomechanics Lab, Inc. | Sacramento, CA, United States | Manufacturer | 2 | October 15, 2025 | 0 | 0 | 0 | api.fda.gov |
| Hemodia SAS | Labege Haute-Garonne, France | Manufacturer | 2 | March 9, 2023 | 0 | 0 | 0 | api.fda.gov |
| Hoogland Spine Products GmbH | Unterfoehring Munich Bavaria, Germany | Exporter to the US, Specification developer | 2 | October 9, 2009 | 0 | 0 | 0 | api.fda.gov |
| Imedicom Co., Ltd. | Gunpo-si Gyeonggi, South Korea | Manufacturer | 2 | April 6, 2019 | 0 | 0 | 0 | api.fda.gov |
| Integrated Endoscopy, Inc. | Irvine, CA, United States | Complaint file establishment, Specification developer | 2 | July 11, 2019 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Puerto Rico Operations Co., Humacao | Humacao, PR, United States | Manufacturer | 2 | November 24, 2000 | 0 | 0 | 0 | api.fda.gov |
| Medline ReNewal | Redmond, OR, United States | Reprocessor | 2 | December 20, 2011 | 0 | 1 | 0 | api.fda.gov |
| Olympus Winter & Ibe GMBH | Hamburg, Germany | Manufacturer | 2 | April 21, 2016 | 0 | 0 | 0 | api.fda.gov |
| Orthopedic Sciences, Inc | Overland Park, KS, United States | Complaint file establishment, Specification developer | 2 | February 26, 2014 | 0 | 0 | 0 | api.fda.gov |
| Surgentec LLC | Boca Raton, FL, United States | Manufacturer | 2 | October 14, 2026 | 0 | 0 | 0 | api.fda.gov |
| Viseon, Inc. | Irvine, CA, United States | Manufacturer | 2 | July 11, 2019 | 0 | 0 | 0 | api.fda.gov |
| asap endoscopic products GmbH | Umkirch Baden-Wurttemberg, Germany | Manufacturer | 2 | January 8, 2013 | 0 | 0 | 0 | api.fda.gov |
| Adria SRL. | San Giovanni in Persiceto Bologna, Italy | Manufacturer | 1 | December 8, 2014 | 0 | 1 | 0 | api.fda.gov |
| Aju Medical Co., Ltd. | Seongnam-si Gyeonggi, South Korea | Manufacturer | 1 | March 16, 2017 | 0 | 0 | 0 | api.fda.gov |
| ArthroCare Corporation | Austin, TX, United States | Specification developer | 1 | June 28, 2001 | 0 | 1 | 0 | api.fda.gov |
| Biopsybell S.R.L. | MIRANDOLA Modena, Italy | Manufacturer, Repackager or relabeler | 1 | March 26, 2018 | 0 | 0 | 0 | api.fda.gov |
| Conmed Corporation | Utica, NY, United States | Complaint file establishment, Manufacturer | 1 | November 14, 2018 | 0 | 0 | 0 | api.fda.gov |
| Covidien | - Santo Domingo, Dominican Republic | Contract manufacturer, Manufacturer | 1 | November 21, 1994 | 0 | 0 | 0 | api.fda.gov |
| Depuy Spine, Inc. | Raynham, MA, United States | Specification developer | 1 | October 18, 2022 | 0 | 0 | 0 | api.fda.gov |
| Dewimed Medizintechnik GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Manufacturer | 1 | May 31, 2006 | 0 | 0 | 0 | api.fda.gov |
| E Surgical, LLC | Sparks, NV, United States | Specification developer | 1 | February 6, 2024 | 0 | 0 | 0 | api.fda.gov |
| Henke-Sass Wolf, GMBH. | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer, Manufacturer | 1 | January 17, 1997 | 0 | 0 | 0 | api.fda.gov |
| Innoview GMBH | Eichstetten Baden-Wurttemberg, Germany | Manufacturer | 1 | September 11, 1996 | 0 | 0 | 0 | api.fda.gov |
| Insightra Medical, Inc. | Clarksville, TN, United States | Complaint file establishment, Specification developer | 1 | February 24, 2010 | 0 | 0 | 0 | api.fda.gov |
| Intravu, Inc. | Redwood City, CA, United States | Manufacturer | 1 | August 21, 2018 | 0 | 0 | 0 | api.fda.gov |
| Izi Medical Products LLC | Owings Mills, MD, United States | Manufacturer | 1 | August 12, 2020 | 0 | 0 | 0 | api.fda.gov |
| Jiangsu Changmei Medtech Co.,ltd | Changzhou Jiangsu, China | Complaint file establishment, Manufacturer | 1 | August 16, 2023 | 0 | 0 | 0 | api.fda.gov |
| Joimax GMBH | KARLSRUHE Baden-Wurttemberg, Germany | Manufacturer | 1 | August 12, 2005 | 0 | 0 | 0 | api.fda.gov |
| Medacta International SA | Castel San Pietro Ticino, Switzerland | Complaint file establishment, Manufacturer | 1 | October 1, 2020 | 0 | 0 | 0 | api.fda.gov |
| Medacta International SA | Rancate Ticino, Switzerland | Complaint file establishment, Manufacturer | 1 | October 1, 2020 | 0 | 0 | 0 | api.fda.gov |
| Medimaging Integrated Solution Inc. | Hsinchu Hsinchu(City), Taiwan | Manufacturer | 1 | December 23, 2025 | 0 | 0 | 0 | api.fda.gov |
| Medtec Applications, Inc. | Glendale Heights, IL, United States | Manufacturer | 1 | July 25, 1989 | 0 | 0 | 0 | api.fda.gov |
| Merit Medical Systems, Inc. | South Jordan, UT, United States | Manufacturer | 1 | October 9, 2019 | 0 | 0 | 0 | api.fda.gov |
| Modern Medical Equipment Manufacturing, Ltd. | Kwai Chung, N.T., Hong Kong | Contract manufacturer, Manufacturer | 1 | May 31, 2018 | 0 | 0 | 0 | api.fda.gov |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd | Changzhou Jiangsu, China | Manufacturer | 1 | November 24, 2000 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Medical Costa Rica S.R.L. | Coyol Alajuela, Costa Rica | Manufacturer | 1 | November 10, 1999 | 0 | 0 | 0 | api.fda.gov |
| National Advanced Endoscopy Devices, Inc. | Canoga Park, CA, United States | Manufacturer, Repackager or relabeler | 1 | December 2, 1999 | 0 | 0 | 0 | api.fda.gov |
| Nexus CMF | Salt Lake City, UT, United States | Complaint file establishment, Specification developer | 1 | March 18, 2008 | 0 | 0 | 0 | api.fda.gov |
| Orthofix Us LLC | Lewisville, TX, United States | Specification developer | 1 | September 25, 1997 | 0 | 0 | 0 | api.fda.gov |
| Pristine Surgical LLC | Palm Harbor, FL, United States | Complaint file establishment, Specification developer | 1 | December 21, 2022 | 0 | 0 | 0 | api.fda.gov |
| Providence Medical Technology, Inc. | Pleasanton, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | March 8, 2019 | 0 | 0 | 0 | api.fda.gov |
| Prosurg, Inc | San Jose, CA, United States | Manufacturer | 1 | July 11, 2016 | 0 | 0 | 0 | api.fda.gov |
| Rafael Medical Devices, LLC | Newark, NJ, United States | Specification developer | 1 | December 11, 2024 | 0 | 0 | 0 | api.fda.gov |
| Renovo, Inc. | Bend, OR, United States | Reprocessor | 1 | October 4, 2017 | 0 | 1 | 0 | api.fda.gov |
| RZ Medizintechnik GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Manufacturer | 1 | April 14, 2014 | 0 | 0 | 0 | api.fda.gov |
| Santa Barbara Imaging Systems | Goleta, CA, United States | Manufacturer, Repackager or relabeler, Specification developer | 1 | March 18, 2008 | 0 | 0 | 0 | api.fda.gov |
| Schoelly Fiberoptic, GMBH | DENZLINGEN Baden-Wurttemberg, Germany | Manufacturer | 1 | June 2, 2014 | 0 | 0 | 0 | api.fda.gov |
| Schoelly Usa Inc. | Northborough, MA, United States | Manufacturer | 1 | June 2, 2014 | 0 | 0 | 0 | api.fda.gov |
| Shanghai Lange Medtech Co., Ltd. | Shanghai, China | Manufacturer | 1 | November 3, 2025 | 0 | 0 | 0 | api.fda.gov |
| SONEX HEALTH, Inc | Eagan, MN, United States | Complaint file establishment, Specification developer | 1 | September 29, 2025 | 0 | 0 | 0 | api.fda.gov |
| Sopro | LA CIOTAT CEDEX Bouches-du-Rhone, France | Manufacturer | 1 | July 11, 2008 | 0 | 0 | 0 | api.fda.gov |
| Spinal Elements, Inc. | Carlsbad, CA, United States | Complaint file establishment, Manufacturer | 1 | February 27, 2009 | 0 | 0 | 0 | api.fda.gov |
| Spinal Simplicity, LLC | Overland Park, KS, United States | Complaint file establishment, Specification developer | 1 | April 16, 2026 | 0 | 0 | 0 | api.fda.gov |
| SPINEFRONTIER, INC. DBA LESspine Innovations | Burlington, MA, United States | Manufacturer, Specification developer | 1 | August 27, 2025 | 0 | 0 | 0 | api.fda.gov |
| Stryker Leibinger GMBH & Co. KG | FREIBURG Baden-Wurttemberg, Germany | Complaint file establishment, Specification developer | 1 | February 24, 1988 | 0 | 0 | 0 | api.fda.gov |
| Stryker Sustainability Solutions | Tempe, AZ, United States | Reprocessor, Specification developer | 1 | November 7, 2001 | 0 | 1 | 0 | api.fda.gov |
| Stryker Sustainability Solutions - Chandler | Chandler, AZ, United States | Reprocessor | 1 | November 7, 2001 | 0 | 0 | 0 | api.fda.gov |
| Synthes GMBH | Selzach Solothurn, Switzerland | Manufacturer | 1 | December 7, 2012 | 0 | 0 | 0 | api.fda.gov |
| Taeyeon Medical Co., Ltd. | Wonju-si Gangwon, South Korea | Manufacturer | 1 | February 3, 2021 | 0 | 0 | 0 | api.fda.gov |
| Tecres SPA | VERONA Veneto, Italy | Exporter to the US, Manufacturer | 1 | August 16, 2023 | 0 | 0 | 0 | api.fda.gov |
| 3D MEDICAL MANUFACTURING, INC. (dba Tecomet) | Riviera Beach, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| A&m Biomedical Inc. | Laguna Hills, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| AB Medical Technologies, Inc. | Redding, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Accumedix, Inc. | Libertyville, IL, 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 | |
| Aspen Surgical Products, Inc. | Caledonia, MI, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Avid Medical, Inc. A Medical Action Ind. Company 305 | Toano, VA, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Axcesor LLC | Menomonee Falls, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arthrex Manufacturing Inc. | Pendleton, SC, United States | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arthrex, Inc. | Ave Maria, FL, United States | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| B. Braun Us Device Manufacturing LLC | Allentown, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Baxter Healthcare Corporation | Round Lake, IL, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Baxter Productos Medicos, Ltda. | 1-7052 Cartago, Costa Rica | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| BM Korea Co., Ltd. | Gunpo-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bruetsch Technology AG | Beringen Schaffhausen, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Baxter Healthcare, S.A. | Haina San Cristobal, Dominican Republic | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Baxter Limited | Marsa, Malta | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biomerics Alajuela | Alajuela, Costa Rica | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| C & J Industries, Inc. | Meadville, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CEA Global Dominicana d.b.a. Nissha Medical Technologies | San Pedro de Macoris, Dominican Republic | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Command Medical Nicaragua SA | Managua, Nicaragua | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Command Medical Products, LLC. | Ormond Beach, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Consolidated Medical Equipment Company | Chihuahua, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Criterion Tool & Die Inc DBA Criterion Precision Machining | Brookpark, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| D & R Products Co., Inc. | Hudson, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Bao Kang Dian Zi Ke Ji Limited | Dongguan City Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dragon Crown Medical Co., Ltd. | Jinan Shandong, China | 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 | |
| First Article Inc | Souderton, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| G21 S.R.I. | San Possidonio Modena, Italy | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gebruder Renggli, AG | Schaffhausen, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Global Interconnect, Inc. | Pocasset, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GS Medical Co., Ltd. | Heungdeok-gu, Cheongju-si Chungbuk, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gyrus Medical Ltd. | CARDIFF Wales, United Kingdom | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hanchang Co., Ltd | Bucheon-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| HARMAC MEDICAL PRODUCTS, INC./H3 de Tijuana, S. de RL de CV | Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Henke Sass Wolf Of America, Inc. | Dudley, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Honduras Kitting, S.A. | Villanueva Cortes, Honduras | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Infus Medical (thailand) Co., Ltd. | Amphoe Muang Samutprakarn Samut Prakan, Thailand | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Infus Medical Co., Ltd. | Khon Kaen Province, Thailand | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Intl. Medsurg Connection, Inc. | Schaumburg, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Industrias Apson S.A de C.V | AGUA PRIETA Sonora, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Integra Biotechnical, SA de CV | Tijuana Baja California, Mexico | 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. Sterling Industries Ltd. | Concord Ontario, Canada | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jatex, Inc. | Nappanee, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Shenli Medical Production Co.,ltd | CHANGZHOU Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Joline GMBH & Co. KG | HECHINGEN Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jr-Medizintechnik GMBH & Co KG | Leibertingen 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 | |
| Karl Storz Endovision, Inc. | Charlton, MA, United States | 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 | 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 | |
| Koscher & Wuertz GMBH | SPAICHINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kimball Electronics Poland Sp.z o.o | Tarnowo Podgorne Wielkopolskie, Poland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kimball Solutions - Indianapolis | Indianapolis, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kimball Solutions - Indianapolis | Indianapolis, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| L Z Form KFT | Ajka Veszprem(County), Hungary | 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 | |
| Linemaster Switch Corp. | Woodstock, CT, 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 | |
| Mainstream Medical Devices | Austin, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medline Industries, LP - SPT | Waukegan, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtronic Powered Surgical Solutions | Fort Worth, TX, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Merit Medical Ireland, Ltd | Galway Galway(County), Ireland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mi3 Limited | Blackburn Lancashire, United Kingdom | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Midwest Interventional Systems | Maple Grove, MN, United States | Contract manufacturer | 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 | |
| Minnetronix, Inc. | Saint Paul, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Modern Medical Equipment Manufacturing (qing Yuan) Ltd | QING YUAN Guangdong, China | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Modern Medical Equipment Manufacturing Ltd. | HENG LI, DONGGUAN Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Millstone Medical Outsourcing LLC | Olive Branch, MS, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| New Deantronics Taiwan Ltd. | New Taipei City, Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nexus Medical, LLC | Lenexa, KS, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Novatech Scientific LLC | Boca Raton, FL, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| NextPhase Medical Devices, LLC | Mansfield, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nitinol Devices & Components Costa Rica, S. R. L. | El Coyol Alajuela, Costa Rica | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nypro Inc (Maple Grove) | Maple Grove, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orthoscan, Inc. | Scottsdale, AZ, United States | 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 | |
| Pan-International Precision Electronic Co., Ltd. | Dongguan Guangdong, China | 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 | |
| Peter's Technology (suzhou) Co., Ltd. | Suzhou Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pro-Dex, Inc. | Irvine, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pro-Tech Design & MFG., Inc. | Santa Fe Springs, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paragon Medical Inc. | Smithfield, UT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Penn United Technologies, Inc. | Warminster, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Primo Medical Group, INC | Stoughton, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pro-Dex Inc | Tustin, CA, United States | 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 | |
| RAUMEDIC - Muenchberg | Helmbrechts Bavaria, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Relign Corporation | Santa Clara, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Richard Wolf Medical Instruments Corp. | Vernon Hills, IL, United States | Contract manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Rudolf Medical GMBH + Co. KG | FRIDINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Roechling Medical Lancaster, LLC | Denver, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Schmid Medizintechnik GMBH | WURMLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Schoelly-Optix Ood | Panagyurishte Pazardzhik, Bulgaria | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Scientific Molding Corporation, Ltd. Dba SMC Ltd. | Amery, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Scivita Medical Technology Co., Ltd. | suzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SHANGHAI KiNETIC MEDICAL CO LTD | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| STERIL VERONA s.r.l. | ERBE Verona, Italy | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Steripack Asia Sdn Bhd | Klang Selangor, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Storz Endoskop Produktions GMBH | Schaffhausen, Switzerland | 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 | |
| STRYKER Communications, Inc. | Flower Mound, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sutter Medizintechnik GMBH | Emmendingen Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Synthes GMBH | Zuchwil Solothurn, Switzerland | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sanmina | San Jose, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Structure Medical, LLC. | Mooresville, NC, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Surgical Specialties Mexico S DE RL DE CV | Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Synthes (USA) Products LLC | West Chester, PA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Telea Electronic Engineering S.R.L. | Sandrigo Vicenza, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Thermedx, LLC | Solon, OH, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tontarra Medizintechnik GMBH | WURMLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Teufel & Gerlach GmbH | Tuttlingen Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| TranS1 | Magnolia, TX, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vomed Volzer Medizintechnik GMBH & Co.kg | Tuttlingen Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Venusa de Mexico S. de R.L de C.V | CIUDAD JUAREZ Chihuahua, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Viant AS&O Holdings, LLC | Laconia, NH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Viant San Antonio, Inc. | San Antonio, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zavation | Flowood, MS, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zien Medical Technologies LLC | Salt Lake City, UT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated October 14, 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.