Data / Medical devices / Laparoscope, General & Plastic Surgery
Laparoscope, General & Plastic Surgery (GCJ): 346 FDA-registered makers in 32 countries
346 establishments in 32 countries are registered with the FDA to make Laparoscope, General & Plastic Surgery (product code GCJ, Class 2, 21 CFR 876.1500). 182 of them have a 510(k) clearance or PMA approval on file and 22 have a recall event. The FDA has issued 1,431 510(k) clearances under this code, the latest on October 14, 2026, and lists 94 recall events (2 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
- GCJ
- Device class
- 2
- Regulation
- 876.1500
- Medical specialty
- Gastroenterology, Urology
Makers by country
| Country | Makers |
|---|---|
| United States | 146 |
| Germany | 64 |
| China | 36 |
| Mexico | 19 |
| Japan | 14 |
| Israel | 8 |
| Taiwan | 7 |
| France | 6 |
| United Kingdom | 5 |
| South Korea | 5 |
| Canada | 3 |
| Switzerland | 3 |
| Dominican Republic | 2 |
| Costa Rica | 2 |
| Australia | 2 |
| Italy | 2 |
| Pakistan | 2 |
| Malaysia | 2 |
| Singapore | 2 |
| Guatemala | 2 |
| Thailand | 2 |
| Bulgaria | 2 |
| Turkey | 1 |
| Belgium | 1 |
| Ireland | 1 |
| Indonesia | 1 |
| Netherlands | 1 |
| Estonia | 1 |
| Malta | 1 |
| Hong Kong | 1 |
| Czechia | 1 |
| Poland | 1 |
Makers of Laparoscope, General & Plastic Surgery
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 |
|---|---|---|---|---|---|---|---|---|
| Covidien | North Haven, CT, United States | Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer | 56 | June 27, 2022 | 0 | 4 | 0 | api.fda.gov |
| Karl Storz Se & Co KG | TUTTLINGEN Baden-Wurttemberg, Germany | Specification developer | 52 | September 1, 2026 | 0 | 0 | 0 | api.fda.gov |
| Stryker Endoscopy | San Jose, CA, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 41 | February 18, 2026 | 0 | 10 | 0 | api.fda.gov |
| Conmed Corporation | Utica, NY, United States | Complaint file establishment, Manufacturer, Manufacturer for export, Repackager or relabeler | 39 | February 19, 2021 | 0 | 3 | 0 | api.fda.gov |
| Covidien | Ponce, PR, United States | Contract manufacturer, Manufacturer | 34 | October 18, 2016 | 0 | 0 | 0 | api.fda.gov |
| Covidien | - Santo Domingo, Dominican Republic | Manufacturer | 31 | June 27, 2022 | 0 | 0 | 0 | api.fda.gov |
| ConMed Corporation | Greenwood Village, CO, United States | Specification developer | 25 | February 19, 2021 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Distribution Center | Memphis, TN, United States | Manufacturer | 20 | March 8, 2017 | 0 | 0 | 0 | api.fda.gov |
| Applied Medical Resources Corp. | Rsm, CA, United States | Complaint file establishment, Contract manufacturer, Manufacturer | 19 | November 1, 2023 | 0 | 10 | 0 | api.fda.gov |
| Applied Medical Distribution Center | Irvine, CA, United States | Manufacturer | 18 | November 1, 2023 | 0 | 0 | 0 | api.fda.gov |
| Intuitive Surgical, Inc. | Sunnyvale, CA, United States | Specification developer | 17 | October 14, 2026 | 0 | 1 | 0 | api.fda.gov |
| Sanmed Medikal Otomotiv Tekstil Ticaret Limited Sirketi | Istanbul, Turkey | Exporter to the US, Manufacturer | 17 | June 27, 2022 | 0 | 0 | 0 | api.fda.gov |
| Linvatec Corporation | Largo, FL, United States | Complaint file establishment, Manufacturer, Specification developer | 16 | July 8, 2020 | 0 | 0 | 0 | api.fda.gov |
| Smith & Nephew Inc. | Oklahoma City, OK, United States | Manufacturer | 15 | October 20, 2022 | 0 | 0 | 0 | api.fda.gov |
| Richard Wolf GMBH | KNITTLINGEN Baden-Wurttemberg, Germany | Manufacturer | 14 | May 14, 2008 | 0 | 0 | 0 | api.fda.gov |
| Arthrex, Inc. | Naples, FL, United States | Specification developer | 13 | October 16, 2025 | 0 | 0 | 0 | api.fda.gov |
| Sopro | LA CIOTAT CEDEX Bouches-du-Rhone, France | Manufacturer | 13 | April 1, 2009 | 0 | 0 | 0 | api.fda.gov |
| Smith & Nephew Inc. | Andover, MA, United States | Specification developer | 12 | October 20, 2022 | 0 | 2 | 0 | api.fda.gov |
| Teleflex Medical LLC | Morrisville, NC, United States | Complaint file establishment, Specification developer | 12 | April 9, 2020 | 0 | 4 | 0 | api.fda.gov |
| Teleflex LLC (NADC) | Olive Branch, MS, United States | Manufacturer, Repackager or relabeler | 11 | April 9, 2020 | 0 | 0 | 0 | api.fda.gov |
| Aesculap AG | TUTTLINGEN, DONAU Baden-Wurttemberg, Germany | Manufacturer | 10 | February 20, 2018 | 0 | 0 | 0 | api.fda.gov |
| Deroyal Industries, Inc. | Powell, TN, United States | Complaint file establishment, Specification developer | 10 | August 17, 2017 | 0 | 1 | 0 | api.fda.gov |
| Gyrus ACMI, Inc. | Brooklyn Park, MN, United States | Complaint file establishment, Manufacturer, Specification developer | 10 | March 9, 2022 | 0 | 0 | 0 | api.fda.gov |
| Olympus Medical Systems Corp. | HACHIOJI-SHI Tokyo, Japan | Exporter to the US, Specification developer | 10 | August 26, 2026 | 0 | 0 | 0 | api.fda.gov |
| STERIS Corporation | Saint Louis, MO, United States | Complaint file establishment, Manufacturer, Repackager or relabeler | 10 | February 1, 2016 | 0 | 0 | 0 | api.fda.gov |
| Ethicon Endo-Surgery, Inc. | Cincinnati, OH, United States | Specification developer | 9 | October 1, 2012 | 0 | 5 | 0 | api.fda.gov |
| Ethicon Endo-Surgery, LLC | Guaynabo, PR, United States | Specification developer | 9 | October 1, 2012 | 0 | 0 | 0 | api.fda.gov |
| Teleflex Medical de Tecate, S. de R.L de C.V. | TECATE Baja California, Mexico | Contract manufacturer, Manufacturer | 8 | January 21, 2015 | 0 | 0 | 0 | api.fda.gov |
| Aspen Surgical Products, Inc. | Caledonia, MI, United States | Manufacturer | 7 | November 12, 2014 | 0 | 2 | 0 | api.fda.gov |
| Olympus Winter & Ibe GMBH | Hamburg, Germany | Complaint file establishment, Exporter to the US, Manufacturer, Specification developer | 7 | April 3, 2020 | 0 | 0 | 0 | api.fda.gov |
| Guangdong Optomedic Technologies, Inc. | Foshan Guangdong, China | Manufacturer | 6 | October 29, 2025 | 0 | 0 | 0 | api.fda.gov |
| Humantouch Surgical Ltd. | Netanya Central, Israel | Complaint file establishment, Manufacturer | 6 | June 5, 2023 | 0 | 0 | 0 | api.fda.gov |
| Micromedics, Inc. | Saint Paul, MN, United States | Manufacturer | 6 | July 15, 2024 | 0 | 0 | 0 | api.fda.gov |
| Surgical Innovations Ltd | Leeds, United Kingdom | Manufacturer | 6 | June 18, 2021 | 0 | 3 | 0 | api.fda.gov |
| Sony Corporation | Yokohama-shi Kanagawa, Japan | Complaint file establishment, Specification developer | 6 | August 26, 2026 | 0 | 0 | 0 | api.fda.gov |
| Arthrex GmbH | Munich Bavaria, Germany | Exporter to the US, Specification developer | 5 | July 25, 2024 | 0 | 0 | 0 | api.fda.gov |
| LG Electronics Inc. | Gumi-si Gyeongbuk, South Korea | Exporter to the US, Manufacturer | 5 | July 17, 2026 | 0 | 0 | 0 | api.fda.gov |
| LG Electronics Nanjing New Technology Co., Ltd. | Nanjing Jiangsu, China | Exporter to the US, Manufacturer | 5 | July 17, 2026 | 0 | 0 | 0 | api.fda.gov |
| NDS Surgical Imaging, LLC. | Sarasota, FL, United States | Manufacturer, Specification developer | 5 | October 19, 2022 | 0 | 0 | 0 | api.fda.gov |
| Shirakawa Olympus Co., Ltd. | NISHISHIRAKAWA-GUN Fukushima, Japan | Manufacturer | 5 | April 3, 2020 | 0 | 0 | 0 | api.fda.gov |
| Tekno Medical Optik-Chirurgie GMBH | TUTTLINGEN-Nendingen Baden-Wurttemberg, Germany | Contract manufacturer, Repackager or relabeler | 5 | February 20, 2007 | 0 | 0 | 0 | api.fda.gov |
| Xenocor, Inc. | Salt Lake City, UT, United States | Complaint file establishment, Specification developer | 5 | February 12, 2026 | 0 | 0 | 0 | api.fda.gov |
| Arthrex California Technology, Incorporated | Santa Barbara, CA, United States | Contract manufacturer, Contract sterilizer, Manufacturer, Specification developer | 4 | October 16, 2025 | 0 | 0 | 0 | api.fda.gov |
| Coopersurgical, Inc. | Trumbull, CT, United States | Manufacturer, Repackager or relabeler | 4 | February 15, 2002 | 0 | 1 | 0 | api.fda.gov |
| Integra LifeSciences Production Corporation | Mansfield, MA, United States | Specification developer | 4 | September 11, 2012 | 0 | 0 | 0 | api.fda.gov |
| Microline Surgical, Inc | Beverly, MA, United States | Complaint file establishment, Manufacturer | 4 | April 29, 2019 | 0 | 0 | 0 | api.fda.gov |
| Nordson MEDICAL Mexico | Guaymas Sonora, Mexico | Contract manufacturer, Exporter to the US | 4 | January 8, 2013 | 0 | 0 | 0 | api.fda.gov |
| Novadaq Technologies ULC | Burnaby British Columbia, Canada | Complaint file establishment, Manufacturer, Specification developer | 4 | November 21, 2018 | 0 | 1 | 0 | api.fda.gov |
| Pajunk GMBH Medizintechnologie | GEISINGEN Baden-Wurttemberg, Germany | Contract manufacturer, Manufacturer | 4 | April 16, 2009 | 0 | 0 | 0 | api.fda.gov |
| Santa Barbara Imaging Systems | Goleta, CA, United States | Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer | 4 | February 28, 2023 | 0 | 0 | 0 | api.fda.gov |
| AB Medica SAS | Mery Sur Cher Centre-Val de Loire, France | Manufacturer, Repackager or relabeler | 3 | January 23, 2026 | 0 | 0 | 0 | api.fda.gov |
| Deroyal Industries, Inc. | New Tazewell, TN, United States | Contract manufacturer, Repackager or relabeler | 3 | October 30, 2003 | 0 | 0 | 0 | api.fda.gov |
| Flexbar Machine Corp. | Islandia, NY, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 3 | December 11, 2013 | 0 | 0 | 0 | api.fda.gov |
| FUJIFILM Corporation Medical Systems Research & Development Center Kaisei | Ashigarakami-Gun Kanagawa, Japan | Contract manufacturer, Manufacturer | 3 | December 2, 2021 | 0 | 0 | 0 | api.fda.gov |
| FUJIFILM Healthcare Manufacturing Corporation Hanamaki Office | HANAMAKI-SHI Iwate, Japan | Manufacturer | 3 | December 2, 2021 | 0 | 0 | 0 | api.fda.gov |
| Intuitive Surgical, S. de R.L. de C.V. | Mexicali Baja California, Mexico | Exporter to the US, Manufacturer | 3 | July 14, 2026 | 0 | 0 | 0 | api.fda.gov |
| Lsi Solutions Inc. | Victor, NY, United States | Manufacturer | 3 | January 12, 2024 | 0 | 0 | 0 | api.fda.gov |
| Maquet Cardiovascular LLC | Wayne, NJ, United States | Manufacturer, Specification developer | 3 | April 15, 2020 | 0 | 0 | 0 | api.fda.gov |
| RG Medical USA | Mount Juliet, TN, United States | Repackager or relabeler, Specification developer | 3 | August 23, 1994 | 0 | 0 | 0 | api.fda.gov |
| Schoelly Fiberoptic, GMBH | DENZLINGEN Baden-Wurttemberg, Germany | Contract manufacturer, Manufacturer | 3 | June 20, 2024 | 0 | 0 | 0 | api.fda.gov |
| Scivita Medical Technology Co., Ltd. | suzhou Jiangsu, China | Manufacturer | 3 | January 13, 2023 | 0 | 0 | 0 | api.fda.gov |
| Sharp Fluidics, Inc. | El Granada, CA, United States | Complaint file establishment, Specification developer | 3 | November 8, 2018 | 0 | 0 | 0 | api.fda.gov |
| Taiwan Surgical Corporation | Zhubei City Hsinchu(County), Taiwan | Manufacturer | 3 | June 2, 2026 | 0 | 0 | 0 | api.fda.gov |
| Terumo Cardiovascular Systems Corporation | Elkton, MD, United States | Manufacturer | 3 | May 12, 2010 | 0 | 1 | 0 | api.fda.gov |
| Unimax Medical Systems Inc. | New Taipei City, Taiwan | Exporter to the US, Specification developer | 3 | October 17, 2011 | 0 | 1 | 0 | api.fda.gov |
| Unimax Medical Systems Inc. | Yilan County, Taiwan | Manufacturer | 3 | October 17, 2011 | 0 | 0 | 0 | api.fda.gov |
| Unimicro Medical Systems (shenzhen) Co., Ltd. | ShenZhen Guangdong, China | Manufacturer | 3 | August 10, 2015 | 0 | 0 | 0 | api.fda.gov |
| Applied Medical Technology, Inc. | Brecksville, OH, United States | Manufacturer | 2 | July 5, 2024 | 0 | 0 | 0 | api.fda.gov |
| Atc Technologies Inc. | Wilmington, MA, United States | Contract manufacturer, Manufacturer | 2 | December 18, 1998 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Marlborough, MA, United States | Complaint file establishment, Specification developer | 2 | February 10, 1997 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | El Coyol Alajuela, Costa Rica | Manufacturer | 2 | February 10, 1997 | 0 | 0 | 0 | api.fda.gov |
| C2Dx, Inc. | Schoolcraft, MI, United States | Complaint file establishment, Manufacturer | 2 | December 15, 2014 | 0 | 0 | 0 | api.fda.gov |
| Dannik | Orlando, FL, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 2 | March 12, 2025 | 0 | 0 | 0 | api.fda.gov |
| Davol Inc., Sub. C.R. Bard, Inc. | Warwick, RI, United States | Complaint file establishment, Specification developer | 2 | March 16, 1995 | 0 | 3 | 0 | api.fda.gov |
| Eizo Corporation | HAKUSAN Ishikawa, Japan | Manufacturer | 2 | September 11, 2026 | 0 | 0 | 0 | api.fda.gov |
| Ethicon, Inc. | Somerville, NJ, United States | Manufacturer | 2 | August 9, 2005 | 0 | 0 | 0 | api.fda.gov |
| Ethicon, Inc. | Raritan, NJ, United States | Manufacturer, Specification developer | 2 | August 9, 2005 | 0 | 0 | 0 | api.fda.gov |
| FUJIFILM Healthcare Manufacturing Corporation Sano Office | Sano City Tochigi, Japan | Manufacturer | 2 | June 30, 2021 | 0 | 0 | 0 | api.fda.gov |
| Lagis Enterprise Co., Ltd. | Dajia Dist, Taichung City, Taiwan | Manufacturer | 2 | March 17, 2025 | 0 | 0 | 0 | api.fda.gov |
| Mahe Medical Usa | Laramie, WY, United States | Complaint file establishment, Specification developer | 2 | August 23, 1994 | 0 | 0 | 0 | api.fda.gov |
| Mitaka Kohki Co., Ltd. | MITAKA SHI Tokyo, Japan | Contract manufacturer, Manufacturer | 2 | July 6, 2009 | 0 | 0 | 0 | api.fda.gov |
| Schoelly Usa Inc. | Northborough, MA, United States | Manufacturer | 2 | December 5, 2014 | 0 | 0 | 0 | api.fda.gov |
| Silex Medical, LLC | Southington, CT, United States | Manufacturer | 2 | January 26, 1995 | 0 | 0 | 0 | api.fda.gov |
| Smith & Nephew Inc. | Mansfield, MA, United States | Manufacturer | 2 | April 23, 1997 | 0 | 0 | 0 | api.fda.gov |
| Transamerican Technologies International | San Ramon, CA, United States | Manufacturer | 2 | February 14, 1994 | 0 | 0 | 0 | api.fda.gov |
| Zhuhai Dipu Medical Technology Co., Ltd. | Zhuhai Guangdong, China | Manufacturer | 2 | June 26, 2024 | 0 | 0 | 0 | api.fda.gov |
| Ackermann Instrumente GMBH | RIETHEIM, WEILHEIM Baden-Wurttemberg, Germany | Contract manufacturer, Manufacturer | 1 | April 21, 1998 | 0 | 0 | 0 | api.fda.gov |
| Advanced Medical Design Co., Ltd. | New Taipei City, Taiwan | Manufacturer | 1 | July 30, 2021 | 0 | 0 | 0 | api.fda.gov |
| Aizu Olympus Co., Ltd. | AIZUWAKAMATSU-SHI Fukushima, Japan | Manufacturer | 1 | January 30, 2002 | 0 | 0 | 0 | api.fda.gov |
| Anchor Products Co. | Addison, IL, United States | Manufacturer | 1 | September 23, 2009 | 0 | 1 | 0 | api.fda.gov |
| AOMORI OLYMPUS CO., LTD. Kuroishi Site | KUROISHI-SHI Aomori, Japan | Manufacturer | 1 | January 30, 2002 | 0 | 0 | 0 | api.fda.gov |
| Ark Surgical | Nazareth Haifa, Israel | Manufacturer | 1 | August 25, 2022 | 0 | 0 | 0 | api.fda.gov |
| Armm, Inc. | Huntington Beach, CA, United States | Contract manufacturer, Manufacturer, Repackager or relabeler | 1 | September 23, 1993 | 0 | 0 | 0 | api.fda.gov |
| Ashitaka Factory Of Terumo Corp. | FUJINOMIYA Shizuoka, Japan | Manufacturer | 1 | April 29, 1993 | 0 | 0 | 0 | api.fda.gov |
| AVENT S. de R.L. de C.V. | NOGALES Sonora, Mexico | Manufacturer | 1 | April 29, 1994 | 0 | 0 | 0 | api.fda.gov |
| Activ Surgical Inc | Boston, MA, United States | Complaint file establishment, Manufacturer | 1 | May 16, 1994 | 0 | 0 | 0 | api.fda.gov |
| Arthrex Manufacturing Inc. | Pendleton, SC, United States | Contract manufacturer, Contract sterilizer, Manufacturer | 1 | July 5, 2019 | 0 | 0 | 0 | api.fda.gov |
| Asclepion Laser Technologies GmbH | Jena Thuringia, Germany | Manufacturer | 1 | November 6, 2024 | 0 | 0 | 0 | api.fda.gov |
| Avanos Medical, Inc. | Alpharetta, GA, United States | Specification developer | 1 | April 29, 1994 | 0 | 0 | 0 | api.fda.gov |
| Barco N.V. | KORTRIJK West-Vlaanderen, Belgium | Manufacturer | 1 | December 13, 2024 | 0 | 0 | 0 | api.fda.gov |
| Baxter Healthcare Corporation | Round Lake, IL, United States | Complaint file establishment, Specification developer | 1 | January 8, 2020 | 0 | 0 | 0 | api.fda.gov |
| Beijing Biosis Healing Biological Technology Co., Ltd | Beijing, China | Manufacturer | 1 | August 6, 2020 | 0 | 0 | 0 | api.fda.gov |
| Beijing Hangtian Kadi Technology R&D Institute | Beijing, China | Manufacturer | 1 | February 1, 2018 | 0 | 0 | 0 | api.fda.gov |
| Biomet, Inc. | Warsaw, IN, United States | Manufacturer | 1 | June 4, 2004 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Spencer, IN, United States | Manufacturer | 1 | February 10, 1997 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Coventry, RI, United States | Manufacturer | 1 | February 10, 1997 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Limited | GALWAY Galway(County), Ireland | Manufacturer | 1 | February 10, 1997 | 0 | 0 | 0 | api.fda.gov |
| Clearcam | Austin, TX, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | February 19, 2020 | 0 | 0 | 0 | api.fda.gov |
| Cardinal Health | Hazelwood, MO, United States | Specification developer | 1 | August 24, 1993 | 0 | 0 | 0 | api.fda.gov |
| Cardinal Health (Kenmex Medical Specialties) | TIJUANA Baja California, Mexico | Manufacturer, Repackager or relabeler | 1 | August 24, 1993 | 0 | 0 | 0 | api.fda.gov |
| Consolidated Medical Equipment Company | Chihuahua, Mexico | Contract manufacturer, Manufacturer | 1 | July 8, 2020 | 0 | 0 | 0 | api.fda.gov |
| DePuy Mitek, Inc. | Raynham, MA, United States | Specification developer | 1 | May 16, 1994 | 0 | 0 | 0 | api.fda.gov |
| Elmed, Inc. | Glendale Heights, IL, United States | Manufacturer, Repackager or relabeler | 1 | March 22, 2019 | 0 | 0 | 0 | api.fda.gov |
| Endoclot Plus Co., Ltd. | Suzhou Jiangsu, China | Manufacturer | 1 | January 18, 2017 | 0 | 0 | 0 | api.fda.gov |
| Endocontrol | La Tronche Isere, France | Manufacturer | 1 | December 18, 2008 | 0 | 0 | 0 | api.fda.gov |
| Ethicon, Inc. | CIUDAD JUAREZ Chihuahua, Mexico | Manufacturer | 1 | October 25, 1996 | 0 | 0 | 0 | api.fda.gov |
| Ethicon, LLC | Guaynabo, PR, United States | Manufacturer | 1 | October 25, 1996 | 0 | 0 | 0 | api.fda.gov |
| Fengh Medical Co., Ltd. | Jiangyin Jiangsu, China | Manufacturer | 1 | April 9, 2018 | 0 | 0 | 0 | api.fda.gov |
| Freyja Healthcare, LLC | Boston, MA, United States | Specification developer | 1 | October 20, 2025 | 0 | 0 | 0 | api.fda.gov |
| Fujifilm Corporation | ASHIGARAKAMI-GUN Kanagawa, Japan | Specification developer | 1 | March 10, 2017 | 0 | 0 | 0 | api.fda.gov |
| Fannin UK Ltd | Clevedon North Somerset, United Kingdom | Manufacturer | 1 | September 26, 2011 | 0 | 1 | 0 | api.fda.gov |
| Globus Medical, Inc. | Audubon, PA, United States | Manufacturer | 1 | March 7, 2018 | 0 | 0 | 0 | api.fda.gov |
| Guangzhou T.K Medical Instrument Co., Ltd. | Guangzhou Guangdong, China | Manufacturer | 1 | July 9, 2020 | 0 | 0 | 0 | api.fda.gov |
| Global Medical Production Co. Ltd | JiaXing Zhejiang, China | Manufacturer | 1 | June 6, 2011 | 0 | 0 | 0 | api.fda.gov |
| Hangzhou Hawk Optical Electronic Instruments Co., Ltd. | Hangzhou Zhejiang, China | Manufacturer | 1 | January 29, 2026 | 0 | 0 | 0 | api.fda.gov |
| Hangzhou Kangji Medical Instrument Co., Ltd. | HANGZHOU Zhejiang, China | Contract manufacturer, Manufacturer | 1 | April 9, 2024 | 0 | 0 | 0 | api.fda.gov |
| Hebumedical GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer, Repackager or relabeler | 1 | September 8, 1995 | 0 | 0 | 0 | api.fda.gov |
| Henke-Sass Wolf, GMBH. | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer, Manufacturer | 1 | May 16, 1994 | 0 | 0 | 0 | api.fda.gov |
| Hermann Medizintechnik GMBH | FRIDINGEN Baden-Wurttemberg, Germany | Contract manufacturer, Manufacturer, Repackager or relabeler | 1 | July 29, 2005 | 0 | 0 | 0 | api.fda.gov |
| Hunan Endoso Life Technology Co., Ltd | XiangTan Hunan, China | Manufacturer | 1 | October 16, 2023 | 0 | 0 | 0 | api.fda.gov |
| I.C. Medical, Inc. | Phoenix, AZ, United States | Manufacturer | 1 | October 7, 1995 | 0 | 0 | 0 | api.fda.gov |
| Icu Medical, Inc. | San Clemente, CA, United States | Complaint file establishment, Specification developer | 1 | November 28, 1983 | 0 | 0 | 0 | api.fda.gov |
| ICU Medical Healthcare Manufacturing S.A. de C.V. | APODACA Nuevo Leon, Mexico | Manufacturer | 1 | November 28, 1983 | 0 | 0 | 0 | api.fda.gov |
| Incore Co., Ltd. | Daegu, South Korea | Manufacturer | 1 | June 21, 2022 | 0 | 0 | 0 | api.fda.gov |
| Integra Microfrance SAS | SAINT AUBIN LE MONIAL Auvergne-Rhone-Alpes, France | Manufacturer | 1 | May 22, 2008 | 0 | 0 | 0 | api.fda.gov |
| Integrated Endoscopy, Inc. | Irvine, CA, United States | Manufacturer | 1 | November 20, 2025 | 0 | 0 | 0 | api.fda.gov |
| Intuitive Surgical Optics GmbH | Freiburg Baden-Wurttemberg, Germany | Manufacturer | 1 | October 14, 2026 | 0 | 0 | 0 | api.fda.gov |
| Intuitive Surgical, Inc. | Sunnyvale, CA, United States | Manufacturer | 1 | July 14, 2026 | 0 | 0 | 0 | api.fda.gov |
| Jiangsu Haize Medical Scientific Development Co.,Ltd. | Wuxi Jiangsu, China | Manufacturer | 1 | June 24, 2016 | 0 | 0 | 0 | api.fda.gov |
| Kronner Prototypes, Inc. | Roseburg, OR, United States | Manufacturer | 1 | May 2, 2000 | 0 | 0 | 0 | api.fda.gov |
| Lexington Medical, Inc. | Bedford, MA, United States | Complaint file establishment, Specification developer | 1 | March 27, 2018 | 0 | 0 | 0 | api.fda.gov |
| Lumenis, Ltd. | YOKNEAM Northern, Israel | Manufacturer, Specification developer | 1 | March 31, 2005 | 0 | 2 | 1 | api.fda.gov |
| Lazurite Inc. | Cleveland, OH, United States | Manufacturer | 1 | March 23, 2022 | 0 | 0 | 0 | api.fda.gov |
| Livac Pty Ltd | Hawthorn Victoria, Australia | Specification developer | 1 | October 20, 2016 | 0 | 0 | 0 | api.fda.gov |
| LivsMed Inc. | Seongnam-si Gyeonggi, South Korea | Manufacturer | 1 | December 3, 2021 | 0 | 0 | 0 | api.fda.gov |
| Med Contact GMBH | Burladingen-Salmendingen Baden-Wurttemberg, Germany | Specification developer | 1 | November 29, 1994 | 0 | 0 | 0 | api.fda.gov |
| Med2b Ltd. | Kitzingen Bavaria, Germany | Manufacturer | 1 | July 19, 2006 | 0 | 0 | 0 | api.fda.gov |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Specification developer | 1 | July 19, 2006 | 0 | 0 | 0 | api.fda.gov |
| Medos International Sarl | Le Locle Neuchatel, Switzerland | Specification developer | 1 | May 16, 1994 | 0 | 0 | 0 | api.fda.gov |
| Nanjing Jusha Display Technology Co., Ltd | Nanjing Jiangsu, China | Manufacturer | 1 | May 31, 2019 | 0 | 0 | 0 | api.fda.gov |
| National Advanced Endoscopy Devices, Inc. | Canoga Park, CA, United States | Manufacturer, Repackager or relabeler | 1 | December 6, 1999 | 0 | 0 | 0 | api.fda.gov |
| Novatech S.A. | LA CIOTAT CEDEX Bouches-du-Rhone, France | Manufacturer | 1 | March 13, 2017 | 0 | 0 | 0 | api.fda.gov |
| Northgate Technologies Inc. | Elgin, IL, United States | Complaint file establishment, Manufacturer | 1 | January 27, 1992 | 0 | 0 | 0 | api.fda.gov |
| Omec Medical NV Inc | Reno, NV, United States | Contract manufacturer, Manufacturer | 1 | June 22, 2020 | 0 | 0 | 0 | api.fda.gov |
| Parallel Robotics, LLC | Ann Arbor, MI, United States | Manufacturer | 1 | May 24, 2026 | 0 | 0 | 0 | api.fda.gov |
| Plasmatica | RaAnana Tel Aviv, Israel | Manufacturer, Repackager or relabeler, Specification developer | 1 | September 12, 2022 | 0 | 0 | 0 | api.fda.gov |
| PT. Team Metal Indonesia | BATAM Riau, Indonesia | Contract manufacturer, Manufacturer | 1 | January 9, 1992 | 0 | 0 | 0 | api.fda.gov |
| Prosurg, Inc | San Jose, CA, United States | Manufacturer | 1 | April 29, 2016 | 0 | 0 | 0 | api.fda.gov |
| Ranfac Corp. | Avon, MA, United States | Contract manufacturer, Manufacturer | 1 | July 11, 1995 | 0 | 0 | 0 | api.fda.gov |
| Scanlan International, Inc. | Saint Paul, MN, United States | Manufacturer, Repackager or relabeler, Specification developer | 1 | December 5, 1994 | 0 | 0 | 0 | api.fda.gov |
| Scopix | Amikam Northern, Israel | Manufacturer | 1 | April 8, 2026 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Sophway Technology Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 1 | October 2, 2025 | 0 | 0 | 0 | api.fda.gov |
| Sidam SRL | Mirandola Modena, Italy | Manufacturer | 1 | July 31, 2020 | 0 | 0 | 0 | api.fda.gov |
| Surgical Principals, Inc. - Spi | Tacoma, WA, United States | Specification developer | 1 | September 22, 2025 | 0 | 0 | 0 | api.fda.gov |
| Shanghai Xodus Medical Company Limited | Shanghai, China | Manufacturer | 1 | September 19, 2018 | 0 | 0 | 0 | api.fda.gov |
| Sinolinks Medical Innovation, Inc. | ChangZhou Jiangsu, China | Complaint file establishment, Manufacturer | 1 | July 11, 2025 | 0 | 0 | 0 | api.fda.gov |
| T.A. Walthem & Company | Sialkot Punjab, Pakistan | Manufacturer | 1 | January 22, 2016 | 0 | 0 | 0 | api.fda.gov |
| T.A.G. Medical Products Corporation Ltd | GAATON Northern, Israel | Manufacturer | 1 | April 28, 2023 | 0 | 0 | 0 | api.fda.gov |
| Thermasolutions LLC. | White Bear Lake, MN, United States | Manufacturer | 1 | December 6, 2022 | 0 | 0 | 0 | api.fda.gov |
| Tianjin Uwell Medical Device Manufacturing Co Ltd | Tianjin, China | Manufacturer | 1 | January 11, 2017 | 0 | 0 | 0 | api.fda.gov |
| Tontarra Medizintechnik GMBH | WURMLINGEN Baden-Wurttemberg, Germany | Contract manufacturer, Exporter to the US | 1 | July 19, 2006 | 0 | 0 | 0 | api.fda.gov |
| Trocare, LLC | Houston, TX, United States | Specification developer | 1 | October 4, 2024 | 0 | 0 | 0 | api.fda.gov |
| Trokamed GMBH | GEISINGEN Baden-Wurttemberg, Germany | Contract manufacturer, Manufacturer | 1 | July 19, 2006 | 0 | 0 | 0 | api.fda.gov |
| Teleflex Medical Inc. | Cincinnati, OH, United States | Specification developer | 1 | April 9, 2020 | 0 | 0 | 0 | api.fda.gov |
| Vascular Technology Incorporated | Nashua, NH, United States | Manufacturer | 1 | June 4, 2014 | 0 | 0 | 0 | api.fda.gov |
| Vernacare Ltd. | Chorley Lancashire, United Kingdom | Manufacturer | 1 | March 4, 2004 | 0 | 0 | 0 | api.fda.gov |
| Well Lead Medical Co. Ltd | GUANGZHOU Guangdong, China | Contract manufacturer, Manufacturer | 1 | November 29, 2016 | 0 | 0 | 0 | api.fda.gov |
| Well Lead Medical Co. Ltd | GUANGZHOU Guangdong, China | Manufacturer | 1 | November 29, 2016 | 0 | 0 | 0 | api.fda.gov |
| Wexler Surgical, Inc. | Houston, TX, United States | Repackager or relabeler, Specification developer | 1 | May 10, 2011 | 0 | 0 | 0 | api.fda.gov |
| Xodus Medical, Inc. | New Kensington, PA, United States | Manufacturer | 1 | September 19, 2018 | 0 | 0 | 0 | api.fda.gov |
| Xpan Inc. | Vaughan Ontario, Canada | Complaint file establishment, Specification developer | 1 | June 2, 2023 | 0 | 0 | 0 | api.fda.gov |
| Zinnanti Surgical Design Group Inc | Santa Cruz, CA, United States | Specification developer | 1 | June 25, 1993 | 0 | 0 | 0 | api.fda.gov |
| Almikro GMBH & Co. KG | Bad Krozingen Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| AVALIGN TECHNOLOGIES, Inc. | Fort Wayne, IN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alleima Karlsruhe GmbH | Karlsruhe Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Altek Biotechnology Corporation | Hsinchu Hsinchu(City), Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Altek Medical Sdn. Bhd. | Iskandar Puteri Johor, Malaysia | Contract manufacturer | 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 | |
| AvailMed S.A.De C.V. | Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| B. Braun Medical Industries Sdn. Bhd. | PENANG Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| B.Y. Medimor Ltd | Tiberias Northern, Israel | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bacher Medizintechnik GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| BAK KOHLER Medical KG | NEUHAUSEN OB ECK-Schwandorf Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Barco S.R.L. | Saronno Varese, Italy | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bard Shannon Limited | Humacao, PR, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beilun Plastech Inc | Ningbo Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bema-Gmbh & Co. KG | EMMINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biomet Microfixation | Jacksonville, FL, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bowa-Electronic GMBH | GOMARINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bruetsch Technology AG | Beringen Schaffhausen, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Barco (Suzhou) Healthcare Technology Co., Ltd. | Suzhou Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boyd Weiler GmbH & Co. KG | Weiler-Simmerberg Bavaria, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Carestream Health, Inc. | Rochester, NY, 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 | |
| Celestica Electronics (S) Pte Ltd. | Singapore Central Singapore, Singapore | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CELESTICA de MONTERREY S.A. de C.V. | Apodaca Nuevo Leon, Mexico | 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 | |
| Comhuge Medical Wire And Harness Technology Co., Ltd | Dongguan Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Canadian Hospital Specialties Ltd. | OAKVILLE Ontario, Canada | Contract manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Cook Incorporated | Bloomington, IN, United States | Complaint file establishment, Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Cook Incorporated | Spencer, IN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| D&T Inc. | Yuseong-gu Daejeon, South Korea | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Davol Surgical Innovations | CD. JUAREZ Chihuahua, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Deroyal Intercontinental, S.R.L. | Santiago, Dominican Republic | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Design Standards Corp. | Charlestown, NH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Honfield Precision Parts Co., Ltd | Zhangmutou, Dongguan Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dufner Instrumente GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dielectrics, Inc. | Chicopee, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Erchinger AG | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ethicon Endo-Surgery S.A. De C.V. Planta Ii | CIUDAD JUAREZ Chihuahua, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eurofins STERIPAC GMBH | Calw-Altburg Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fibertech Co., Ltd. | Sakura-shi Chiba, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fmi Medisch BV | Schiedam Zuid-Holland, Netherlands | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fong's Engineering & Manufacturing Private Limited | Singapore Central Singapore, Singapore | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Faulhaber Pinzetten KG | FRITTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ge Healthcare | Chicago, IL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Geomed Medizin-Technik GMBH & Co. KG | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Geotec, Inc. | Warwick, RI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Getsch + Hiller Medizintechnik GMBH | Tuttlingen Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Glaser AG | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gordian Surgical | M.P. Misgav Northern, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guenter Bissinger Medizintechnik GMBH | TENINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guenter Stoffel Medizintechnik GMBH | WURMLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guatemala Medical Manufacturing | Villa Canales Guatemala, Guatemala | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hafner Chirurgische Instrumente | BALGHEIM Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Endo Medical Instrument Co.,ltd | hangzhou Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Harmac Medical Products, Inc. | Buffalo, NY, United States | 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 | |
| HGR Instrumente GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hupfer Metallwerke GMBH & Co. KG | Coesfeld North Rhine-Westphalia, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hipp Medical AG | Renquishausen Baden-Wurttemberg, Germany | 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 | |
| Intravu, Inc. | Redwood City, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Itek | Cartago, Costa Rica | Contract manufacturer | 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 | |
| Instrumed GmbH dba Avalign German Specialty Instruments | TUTTLINGEN Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Intuitive Surgical Bulgaria EOOD | Parvomay Plovdiv, Bulgaria | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Intuitive Surgical Optics GmbH | Emmendingen Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Intuitive Surgical, Inc. | Phoenix, AZ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| JR Montagearbeiten | TUTTLINGEN Baden-Wurttemberg, Germany | Contract 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 | |
| Jiangsu BANA Medical Technology Co., Ltd. | Changzhou Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Karl Klappenecker GMBH & Co. KG | TUTTLINGEN Baden-Wurttemberg, Germany | 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 Imaging, Inc. | Goleta, CA, 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 | |
| Karl Storz Video Endoscopy Estonia Oue | Laagri Harjumaa, Estonia | 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 | |
| Kunststoff Christel GMBH & Co. KG | Bad Durrheim Baden-Wurttemberg, Germany | 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 | |
| Lexion Medical, LLC. | Saint Paul, MN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Life Science Logistics, LLC | Brownsburg, IN, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| LivaNova USA, INC. | Arvada, CO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| M&L Precision Machining Inc. | Morgan Hill, CA, 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 | |
| Martech Medical Products S. De RL. De CV. | MEXICALI Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mauna Kea Technologies | PARIS Ile-de-France, France | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Max Hauser Suddeutsche Chirurgiemechanik GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medcare Solutions GMBH | Emmingen Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Microtek Medical Malta Limited | Mosta, Malta | 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 Ltd. | HENG LI, DONGGUAN Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Modern Medical Equipment Manufacturing, Ltd. | Kwai Chung, N.T., Hong Kong | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Myriad Fiber Imaging Technologies, Inc. | Dudley, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MediConcepts Technology (Shenzhen) Company Limited | Shenzhen Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medline Industries, LP - Mexicali (MXC) | Mexicali Baja California, Mexico | Contract sterilizer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medline ReNewal | Redmond, OR, United States | Reprocessor | 0 | 0 | 0 | 0 | api.fda.gov | |
| NBS Group Supply- Medical Products Division, LLC | New Brunswick, NJ, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| NDS Surgical Imaging, LLC | Ludwigsstadt Bavaria, Germany | 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 | |
| Norwood Medical LLC | Dayton, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Novanta Medical S.R.O. | Prelouc Pardubicky Kraj, Czechia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Novaprobe Inc. | Lansdale, PA, United States | 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 | |
| NPA de México S. de R.L. de C.V. | TIJUANA Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nissha Medical Technologies (Ohio), Inc. | Norwalk, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Novanta Medical GmbH | LUDWIGSSTADT Bavaria, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Novanta Medical GmbH | Berlin, Germany | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nypro Healthcare Baja Inc. (Albuquerque) | Albuquerque, NM, United States | Contract manufacturer, Contract sterilizer, Manufacturer for export | 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 | |
| Omec Thai Co.,ltd. | Bang Bo District Samut Prakan, Thailand | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ORIGAMI SURGICAL Inc. | Dover, MA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orthoscan, Inc. | Scottsdale, AZ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Olympus Winter & Ibe GmbH | TELTOW Brandenburg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ortho and Surgical Products Enterprises S.A. | Villa Canales Guatemala, Guatemala | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Phillips-Medisize, LLC | New Richmond, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Phoenix Instruments, Inc. | Lisle, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Phoenix Medical Products, Inc. | Mountain City, TN, 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 | |
| PRO-TECH Design & Mfg, Inc. | Santa Fe Springs, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Productos Medline S.A. De C.V. | NUEVO LAREDO Tamaulipas, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Purple Surgical International Limited | Herts England, United Kingdom | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Primo Medical Group, INC | Stoughton, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Primo Medical Group, Inc | W Bridgewater, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Purple Surgical Manufacturing Limited | Taunton Somerset, United Kingdom | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Qingdao O-Mec Medical Technology Co., Ltd. | Qingdao Shandong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Qisda Electronics (suzhou) Co., Ltd. | Suzhou Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Qsa Surgical (pvt) Ltd. | SIALKOT Punjab, Pakistan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| R.K. Manufacturing | Danbury, CT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Richard Wolf Medical Instruments Corp. | Vernon Hills, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rominger Medizintechnik GMBH | SEITINGEN-OBERFLACHT Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rudolf Medical GMBH + Co. KG | FRIDINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rudolf Storz GMBH | EMMINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RZ Medizintechnik GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sabre Medical Pty Ltd | Lane Cove West New South Wales, Australia | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Samax Precision Inc. | Sunnyvale, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Schoelly-Optix Ood | Panagyurishte Pazardzhik, Bulgaria | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen El3imaging Medical Devices Co., Ltd. | Shenzhen Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Jingxintai Houseware Co., Ltd | Shenzhen Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sichuan Innovation Technology Co., Ltd. | Chengdu Sichuan, China | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Steripack Medical Poland SP. Z O.O. | Jelcz-Laskowice Dolnoslaskie, Poland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Steute Technologies GMBH & Co. KG | Loehne North Rhine-Westphalia, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Storz Endoskop Produktions GMBH | Schaffhausen, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Supreme Screw Products | Plainview, NY, United States | 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 | |
| Surgnova Healthcare Technologies (zhejiang) Co., Ltd. | Cixi Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sony Global Manufacturing & Operations Corporation Kohda Site | Nukata-gun Aichi, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Springboard Manufacturing | Rancho Cordova, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Strub Medical GmbH & Co. KG | NEUHAUSEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stryker Sustainability Solutions | Tempe, AZ, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stryker Sustainability Solutions - Chandler | Chandler, AZ, United States | Reprocessor | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stryker Sustainability Solutions Lakeland | Lakeland, FL, United States | Reprocessor | 0 | 0 | 0 | 0 | api.fda.gov | |
| Teufel & Gerlach GmbH | Tuttlingen Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| United States Endoscopy Group, Inc. | Mentor, OH, United States | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Veridiam, LLC | El Cajon, CA, United States | Contract manufacturer | 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 | |
| Vpix Medical, Inc. | Jung-gu Daejeon, South Korea | 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 | Brimfield, MA, United States | Contract manufacturer | 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 | |
| medi-G GMBH | Messkirch Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| medi-plus Instrumente GmbH | TUTTLINGEN-NENDINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| rms Surgical | Anoka, MN, 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.