Data / Medical devices / Continuous Measurement Thermometer
Continuous Measurement Thermometer (FLL): 283 FDA-registered makers in 30 countries
283 establishments in 30 countries are registered with the FDA to make Continuous Measurement Thermometer (product code FLL, Class 2, 21 CFR 880.2910). 152 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 798 510(k) clearances under this code, the latest on June 5, 2026, and lists 14 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
- FLL
- Device class
- 2
- Regulation
- 880.2910
- Medical specialty
- General Hospital
Makers by country
| Country | Makers |
|---|---|
| United States | 101 |
| China | 89 |
| Mexico | 14 |
| Taiwan | 10 |
| Germany | 10 |
| Vietnam | 6 |
| Israel | 5 |
| United Kingdom | 5 |
| South Korea | 5 |
| India | 4 |
| Netherlands | 3 |
| Italy | 3 |
| Malaysia | 3 |
| Switzerland | 2 |
| Cambodia | 2 |
| Thailand | 2 |
| Finland | 2 |
| Japan | 2 |
| France | 2 |
| Costa Rica | 2 |
| Philippines | 2 |
| Turkey | 1 |
| Austria | 1 |
| Hong Kong | 1 |
| Dominican Republic | 1 |
| Singapore | 1 |
| Poland | 1 |
| Bulgaria | 1 |
| Sweden | 1 |
| Brazil | 1 |
Makers of Continuous Measurement Thermometer
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 |
|---|---|---|---|---|---|---|---|---|
| Microlife Corp. | Taipei, Taiwan | Manufacturer | 27 | March 1, 2022 | 0 | 0 | 0 | api.fda.gov |
| Onbo Electronic (shenzhen) Co. Ltd. | SHENZHEN Guangdong, China | Contract manufacturer, Manufacturer | 27 | March 1, 2022 | 0 | 0 | 0 | api.fda.gov |
| Kaz USA, Inc., A Helen of Troy Company | Marlborough, MA, United States | Complaint file establishment, Manufacturer, Specification developer | 24 | April 28, 2020 | 0 | 0 | 0 | api.fda.gov |
| Microlife Intellectual Property GMBH | Widnau Sankt Gallen, Switzerland | Specification developer | 23 | March 1, 2022 | 0 | 0 | 0 | api.fda.gov |
| Kaz USA, Inc., A Helen of Troy Company | Olive Branch, MS, United States | Manufacturer, Repackager or relabeler, Specification developer | 18 | April 28, 2020 | 0 | 0 | 0 | api.fda.gov |
| Avita (wujiang) Co., Ltd | Wujiang City Jiangsu, China | Manufacturer | 11 | July 23, 2018 | 0 | 0 | 0 | api.fda.gov |
| Radiant Innovation Inc. | HSINCHU Hsinchu(County), Taiwan | Specification developer | 11 | June 5, 2024 | 0 | 0 | 0 | api.fda.gov |
| Sevenground Trading B.V. | Dordrecht Zuid-Holland, Netherlands | Exporter to the US, Specification developer | 9 | January 2, 2019 | 0 | 0 | 0 | api.fda.gov |
| Hangzhou Hua'an Medical & Health Instruments Co. | Hangzhou Zhejiang, China | Exporter to the US, Manufacturer | 8 | February 13, 2018 | 0 | 0 | 0 | api.fda.gov |
| Joytech Healthcare Co., Ltd. | Hangzhou Zhejiang, China | Exporter to the US, Manufacturer | 8 | July 8, 2020 | 0 | 0 | 0 | api.fda.gov |
| Joytech Healthcare Co.,ltd. | Hangzhou Zhejiang, China | Exporter to the US, Manufacturer | 8 | July 8, 2020 | 0 | 0 | 0 | api.fda.gov |
| Masena Invest, BV | Dordrecht Zuid-Holland, Netherlands | Specification developer | 8 | January 2, 2019 | 0 | 0 | 0 | api.fda.gov |
| Avita Corporation | San-Chung District, New Taipei City, Taiwan | Manufacturer | 7 | July 23, 2018 | 0 | 0 | 0 | api.fda.gov |
| Icu Medical, Inc. | San Clemente, CA, United States | Complaint file establishment, Specification developer | 7 | September 11, 1992 | 0 | 0 | 0 | api.fda.gov |
| R & D Batteries, Inc. | Burnsville, MN, United States | Manufacturer | 7 | August 18, 1995 | 0 | 0 | 0 | api.fda.gov |
| Hetaida Technology Co., Ltd. | Dongguan Guangdong, China | Contract manufacturer, Manufacturer, Specification developer | 6 | February 25, 2021 | 0 | 0 | 0 | api.fda.gov |
| Medisim Ltd. | Ness Ziona Central, Israel | Complaint file establishment, Foreign private label distributor, Manufacturer, Remanufacturer, Repackager or relabeler, Specification developer | 6 | October 20, 2015 | 0 | 0 | 0 | api.fda.gov |
| Alicn Medical Shenzhen, Inc | Shenzhen Guangdong, China | Manufacturer | 5 | December 22, 2023 | 0 | 0 | 0 | api.fda.gov |
| Beijing Choice Electronic Technololgy Co., Ltd. | Beijing, China | Exporter to the US, Foreign private label distributor, Manufacturer | 5 | January 21, 2022 | 0 | 0 | 0 | api.fda.gov |
| Deroyal Industries, Inc. | Powell, TN, United States | Complaint file establishment, Specification developer | 5 | December 23, 2020 | 0 | 1 | 0 | api.fda.gov |
| Fudakang Industrial Co Ltd | Dongguan Guangdong, China | Manufacturer | 5 | June 7, 2018 | 0 | 0 | 0 | api.fda.gov |
| ICU Medical Healthcare Manufacturing S.A. de C.V. | Tijuana, B.C. C.P. Baja California, Mexico | Manufacturer | 5 | September 11, 1992 | 0 | 0 | 0 | api.fda.gov |
| Rens Medcare (cambodia) Co.,ltd. | Sihanouk Preah Sihanouk, Cambodia | Exporter to the US, Manufacturer | 5 | November 18, 2019 | 0 | 0 | 0 | api.fda.gov |
| Covidien | Ciudad Juarez Chihuahua, Mexico | Manufacturer | 4 | August 20, 2024 | 0 | 0 | 0 | api.fda.gov |
| Covidien | Lafayette, CO, United States | Specification developer | 4 | August 20, 2024 | 0 | 0 | 0 | api.fda.gov |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Complaint file establishment, Specification developer | 4 | September 20, 2021 | 0 | 0 | 0 | api.fda.gov |
| ONFU electronics Co., LTD. | Trang Bom Dong Nai, Vietnam | Contract manufacturer, Manufacturer | 4 | June 10, 2009 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen AOJ Medical Technology Co., Ltd. | Shenzhen Guangdong, China | Contract manufacturer, Manufacturer | 4 | June 23, 2025 | 0 | 0 | 0 | api.fda.gov |
| Tee-Zed Products, LLC | Greensboro, NC, United States | Specification developer | 4 | October 29, 2018 | 0 | 0 | 0 | api.fda.gov |
| Avita Corp (thailand) Co., Ltd. | Chonburi Chon Buri, Thailand | Manufacturer | 3 | July 23, 2018 | 0 | 0 | 0 | api.fda.gov |
| Acute Ideas Co., Ltd. | Taipei, Taiwan | Exporter to the US, Specification developer | 3 | November 28, 2018 | 0 | 0 | 0 | api.fda.gov |
| AirLife Finland Oy | Helsinki Uusimaa, Finland | Specification developer | 3 | September 29, 2006 | 0 | 0 | 0 | api.fda.gov |
| Bioland Technology Ltd. | SHENZHEN Guangdong, China | Manufacturer | 3 | April 5, 2022 | 0 | 0 | 0 | api.fda.gov |
| CIRCA Scientific, Inc. | Englewood, CO, United States | Manufacturer, Specification developer | 3 | May 25, 2023 | 0 | 0 | 0 | api.fda.gov |
| Cotronic Technology Limited | SHENZHEN, GUANG DONG PROVINCE Guangdong, China | Contract manufacturer, Exporter to the US, Manufacturer | 3 | May 17, 2013 | 0 | 0 | 0 | api.fda.gov |
| Cardinal Health | Hazelwood, MO, United States | Specification developer | 3 | May 22, 2006 | 0 | 0 | 0 | api.fda.gov |
| Cardinal Health | Norfolk, NE, United States | Manufacturer | 3 | May 22, 2006 | 0 | 0 | 0 | api.fda.gov |
| Exergen Corporation | Watertown, MA, United States | Manufacturer | 3 | July 12, 2001 | 0 | 0 | 0 | api.fda.gov |
| Exergen Corporation Leominster Warehouse | Leominster, MA, United States | Manufacturer | 3 | July 12, 2001 | 0 | 0 | 0 | api.fda.gov |
| Fiab SPA | Vicchio Firenze, Italy | Exporter to the US, Manufacturer | 3 | October 10, 2019 | 0 | 0 | 0 | api.fda.gov |
| Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | Danyang Jiangsu, China | Manufacturer | 3 | May 22, 2025 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Med-Link Electronics Tech Co.,ltd | Shenzhen Guangdong, China | Contract manufacturer, Manufacturer | 3 | January 8, 2026 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Jumper Medical Equipment Co.,Ltd. | Shenzhen Guangdong, China | Manufacturer | 3 | May 5, 2019 | 0 | 0 | 0 | api.fda.gov |
| Smart Technology Co., Ltd. | Foshan Guangdong, China | Manufacturer, Repackager or relabeler | 3 | September 26, 2021 | 0 | 0 | 0 | api.fda.gov |
| Tecnimed S.R.L. | VEDANO OLONA Varese, Italy | Manufacturer | 3 | April 19, 2017 | 0 | 0 | 0 | api.fda.gov |
| Aion Biosystems | Lowell, MA, United States | Specification developer | 2 | March 14, 2025 | 0 | 0 | 0 | api.fda.gov |
| Blue Spark Technologies, Inc. | Westlake, OH, United States | Manufacturer, Specification developer | 2 | December 3, 2020 | 0 | 0 | 0 | api.fda.gov |
| Cardinal Health | Riverview, FL, United States | Manufacturer | 2 | May 22, 2006 | 0 | 0 | 0 | api.fda.gov |
| Dongguan Simzo Electronic Technology Co., Ltd. | Dongguan Guangdong, China | Manufacturer | 2 | September 3, 2021 | 0 | 0 | 0 | api.fda.gov |
| Fondcircle Inc. | Newport Beach, CA, United States | Specification developer | 2 | October 14, 2023 | 0 | 0 | 0 | api.fda.gov |
| Golden Smart Home Technology Corp. | Hsinchu City Hsinchu(City), Taiwan | Manufacturer | 2 | February 17, 2023 | 0 | 0 | 0 | api.fda.gov |
| Guangdong Genial Technology Co., Ltd. | Zhaoqing Guangdong, China | Manufacturer | 2 | October 30, 2024 | 0 | 0 | 0 | api.fda.gov |
| Geon Corporation | CHANG HWA HSIEN Changhua, Taiwan | Manufacturer | 2 | June 2, 2010 | 0 | 0 | 0 | api.fda.gov |
| Guangzhou Daxin Health Technology (Dongguan) Co., Ltd | Dongguan City Guangdong, China | Manufacturer | 2 | April 25, 2025 | 0 | 0 | 0 | api.fda.gov |
| Hangzhou Universal Electronic Co., Ltd. | Hangzhou Zhejiang, China | Manufacturer | 2 | August 24, 2016 | 0 | 0 | 0 | api.fda.gov |
| Kangfu Medical Equipment Factory | Wenzhou Zhejiang, China | Exporter to the US, Manufacturer | 2 | December 10, 2021 | 0 | 0 | 0 | api.fda.gov |
| Kunshan Radiant Innovation Co., Ltd. | Jiangsu Province, China | Contract manufacturer, Manufacturer | 2 | January 9, 2017 | 0 | 0 | 0 | api.fda.gov |
| Kinsa Health LLC | Lehi, UT, United States | Complaint file establishment, Specification developer | 2 | January 17, 2018 | 0 | 0 | 0 | api.fda.gov |
| Med-Linket Corp | Alhambra, CA, United States | Manufacturer | 2 | August 25, 2020 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Perfusion Systems | Minneapolis, MN, United States | Manufacturer, Specification developer | 2 | May 20, 2016 | 0 | 0 | 0 | api.fda.gov |
| Metko Medikal ve Tibbi Cihazlar Dis Ticaret Sanayi A.S. | Ankara, Turkey | Manufacturer | 2 | October 25, 2024 | 0 | 0 | 0 | api.fda.gov |
| Ningbo Ranor Medical Science & Technology Co., Ltd. | Ningbo Zhejiang, China | Manufacturer | 2 | July 16, 2020 | 0 | 0 | 0 | api.fda.gov |
| Ouachita Contract Manufacturing, LLC | Monroe, LA, United States | Repackager or relabeler, Specification developer | 2 | November 28, 2018 | 0 | 0 | 0 | api.fda.gov |
| R.G. Enterprises (u.s.a.), Inc. | Madison Heights, MI, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 2 | June 5, 2007 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Everbest Machinery Industry Co Ltd | Shenzhen Guangdong, China | Manufacturer | 2 | April 16, 2021 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Finicare Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 2 | February 14, 2025 | 0 | 0 | 0 | api.fda.gov |
| Solventum Us LLC | Eagan, MN, United States | Specification developer | 2 | May 30, 2012 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Rongfeng Technology Co.,Ltd | Shenzhen Guangdong, China | Manufacturer | 2 | July 21, 2023 | 0 | 0 | 0 | api.fda.gov |
| Solventum US LLC | San Antonio, TX, United States | Complaint file establishment, Specification developer | 2 | May 30, 2012 | 0 | 0 | 0 | api.fda.gov |
| Thermoworks Inc. | American Fork, UT, United States | Repackager or relabeler, Specification developer | 2 | June 5, 2024 | 0 | 0 | 0 | api.fda.gov |
| Vega Technologies Inc. | Dongguan City Guangdong, China | Manufacturer | 2 | January 14, 2011 | 0 | 0 | 0 | api.fda.gov |
| Vivalnk, Inc. | Campbell, CA, United States | Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer | 2 | December 20, 2022 | 0 | 0 | 0 | api.fda.gov |
| Wellvii Inc | Palm Beach Gardens, FL, United States | Specification developer | 2 | February 2, 2024 | 0 | 0 | 0 | api.fda.gov |
| Xiamen Ants Bro Technology Co., Ltd. | Xiamen City Fujian, China | Exporter to the US, Manufacturer | 2 | April 22, 2020 | 0 | 0 | 0 | api.fda.gov |
| Amplim, LLC | San Francisco, CA, United States | Specification developer | 1 | October 15, 2013 | 0 | 0 | 0 | api.fda.gov |
| Anriwell | Riverside, CA, United States | Repackager or relabeler, Specification developer | 1 | October 14, 2023 | 0 | 0 | 0 | api.fda.gov |
| Ashitaka Factory Of Terumo Corp. | FUJINOMIYA Shizuoka, Japan | Manufacturer | 1 | June 27, 1985 | 0 | 0 | 0 | api.fda.gov |
| Bear Down Brands, LLC | Fullerton, CA, United States | Complaint file establishment, Specification developer | 1 | December 2, 2009 | 0 | 0 | 0 | api.fda.gov |
| Bodycap | Herouville Saint-Clair Calvados, France | Manufacturer | 1 | June 28, 2023 | 0 | 0 | 0 | api.fda.gov |
| Bailey Instruments Ltd | Manchester, United Kingdom | Manufacturer | 1 | November 30, 2017 | 0 | 0 | 0 | api.fda.gov |
| Brain Tunnelgenix Technologies Corporation | Aventura, FL, United States | Specification developer | 1 | August 17, 2010 | 0 | 0 | 0 | api.fda.gov |
| Conmo Electronic Company Limited | Huizhou City Guangdong, China | Manufacturer | 1 | February 25, 2021 | 0 | 0 | 0 | api.fda.gov |
| Contec Medical Systems Co., Ltd | Qinhuangdao Hebei, China | Manufacturer | 1 | December 18, 2020 | 0 | 0 | 0 | api.fda.gov |
| Coopersurgical, Inc. | Trumbull, CT, United States | Manufacturer | 1 | January 12, 1982 | 0 | 0 | 0 | api.fda.gov |
| Dongguan E-Test Technology Co.,ltd | Dongguan Guangdong, China | Manufacturer | 1 | November 23, 2020 | 0 | 0 | 0 | api.fda.gov |
| Dongguan Jiacom Technology Co., Ltd. | Dongguan Guangdong, China | Manufacturer | 1 | July 12, 2018 | 0 | 0 | 0 | api.fda.gov |
| Dorel Juvenile Group, Inc. | Columbus, IN, United States | Specification developer | 1 | December 6, 1996 | 0 | 0 | 0 | api.fda.gov |
| Draegerwerk AG & Co. KGaA | LUEBECK Schleswig-Holstein, Germany | Specification developer | 1 | February 28, 2013 | 0 | 0 | 0 | api.fda.gov |
| Fortechgrp Co., Ltd. | Taoyuan city, Taiwan | Contract manufacturer, Manufacturer | 1 | February 8, 2007 | 0 | 0 | 0 | api.fda.gov |
| Genesee Biomedical, Inc. | Denver, CO, United States | Manufacturer | 1 | March 26, 1982 | 0 | 0 | 0 | api.fda.gov |
| Gri Medical & Electronic Technology Co., Ltd. | JIAXING Zhejiang, China | Manufacturer | 1 | August 11, 2011 | 0 | 0 | 0 | api.fda.gov |
| Guangzhou Baoli Hardware & Electronic Co.,ltd. | Guangzhou Guangdong, China | Exporter to the US, Manufacturer, Repackager or relabeler | 1 | January 10, 2011 | 0 | 0 | 0 | api.fda.gov |
| Guangdong Prestige Technology Co., Ltd. | Dongguan Guangdong, China | Manufacturer | 1 | March 9, 2021 | 0 | 0 | 0 | api.fda.gov |
| Hadleigh Health Technologies | Sausalito, CA, United States | Specification developer | 1 | August 16, 2023 | 0 | 0 | 0 | api.fda.gov |
| Industrial Vallera de Mexicali, S. A. de C. V. | Mexicali Mexico, Mexico | Manufacturer | 1 | June 11, 2021 | 0 | 0 | 0 | api.fda.gov |
| Kang Ze Industrial Co., Ltd. | Dongguan Guangdong, China | Exporter to the US, Manufacturer | 1 | December 16, 2011 | 0 | 0 | 0 | api.fda.gov |
| LivaNova USA, INC. | Arvada, CO, United States | Manufacturer | 1 | July 19, 1996 | 0 | 0 | 0 | api.fda.gov |
| Masimo Corporation | Irvine, CA, United States | Complaint file establishment, Specification developer | 1 | June 11, 2021 | 0 | 0 | 0 | api.fda.gov |
| Me Center Of Terumo Corp. | FUJINOMIYA Shizuoka, Japan | Manufacturer | 1 | June 27, 1985 | 0 | 0 | 0 | api.fda.gov |
| Mediana Co., Ltd. | Wonju-Si, Gangwon-do, South Korea | Manufacturer | 1 | February 24, 2017 | 0 | 0 | 0 | api.fda.gov |
| Mediusa Inc. | Los Angeles, CA, United States | Remanufacturer, Repackager or relabeler | 1 | October 7, 2020 | 0 | 0 | 0 | api.fda.gov |
| Metene Limited | City of Industry, CA, United States | Specification developer | 1 | July 23, 2018 | 0 | 0 | 0 | api.fda.gov |
| Ningbo Just Soon Industrial Limited | Ningbo Zhejiang, China | Manufacturer | 1 | September 12, 2022 | 0 | 0 | 0 | api.fda.gov |
| Orantech Inc. | Shenzhen Guangdong, China | Exporter to the US, Manufacturer | 1 | October 10, 2018 | 0 | 0 | 0 | api.fda.gov |
| Pinghu Sama Medical Packing Co., Ltd. | Pinghu Zhejiang, China | Manufacturer | 1 | January 15, 2016 | 0 | 0 | 0 | api.fda.gov |
| Productos Urologos De Mexico S.A. De C.V. | MEXICALI Baja California, Mexico | Manufacturer | 1 | September 12, 1979 | 0 | 0 | 0 | api.fda.gov |
| Philips North America LLC | Cambridge, MA, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 1 | July 19, 1996 | 0 | 0 | 0 | api.fda.gov |
| Philips North America LLC | Andover, MA, United States | Repackager or relabeler, Specification developer | 1 | July 19, 1996 | 0 | 0 | 0 | api.fda.gov |
| Qingdao Yasee Medical Device Co.,ltd. | QINGDAO Shandong, China | Manufacturer | 1 | September 12, 2022 | 0 | 0 | 0 | api.fda.gov |
| Remedyrepack, Inc. | Indiana, PA, United States | Manufacturer, Repackager or relabeler | 1 | March 14, 2025 | 0 | 0 | 0 | api.fda.gov |
| Respironics Inc. | Murrysville, PA, United States | Complaint file establishment, Manufacturer | 1 | April 22, 2004 | 0 | 0 | 0 | api.fda.gov |
| Sensatronic GMBH | Wismar Mecklenburg-Western Pomerania, Germany | Manufacturer | 1 | August 11, 2021 | 0 | 0 | 0 | api.fda.gov |
| Shandong Zhushi Pharmaceutical Group Co., Ltd | Heze Shandong, China | Exporter to the US, Manufacturer | 1 | April 29, 2021 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Aeon Technology Co.,ltd | shenzhen Guangdong, China | Manufacturer | 1 | November 30, 2017 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Brav Electronic Technologies Co., Ltd | shenzhen Guangdong, China | Manufacturer | 1 | March 2, 2018 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen BSX Technology Electronics Co.,ltd | Shen Zhen Guangdong, China | Manufacturer | 1 | July 23, 2021 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Changke Connect Electronics Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 1 | July 24, 2020 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Changkun Technology Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 1 | June 17, 2020 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Juzhong Technology Co.,ltd | shenzhen Guangdong, China | Manufacturer | 1 | March 22, 2021 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Launch Electrical Co., Ltd | Shenzhen Guangdong, China | Manufacturer | 1 | December 10, 2018 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Medke Technology Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 1 | June 20, 2025 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Sino-K Medical Technology Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 1 | August 25, 2023 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Urion Technology Co., Ltd. | Shenzhen Guangdong, China | Exporter to the US, Manufacturer | 1 | October 7, 2020 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Zhengkang Technology Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 1 | March 12, 2021 | 0 | 0 | 0 | api.fda.gov |
| Steadysense GMBH | Raaba-Grambach Steiermark, Austria | Manufacturer | 1 | June 21, 2024 | 0 | 0 | 0 | api.fda.gov |
| Suzhou Melodicare Medical Technology Co., Ltd | Suzhou Jiangsu, China | Manufacturer | 1 | October 18, 2019 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen BelterHealthMeasurementAndAnalysisTechnologyCo.,Ltd | Shenzhen Guangdong, China | Manufacturer | 1 | August 21, 2014 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Calibeur Industries Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 1 | October 15, 2019 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Caremed Medical Technology Co.,Ltd. | shenzhen Guangdong, China | Contract manufacturer, Manufacturer | 1 | September 6, 2019 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Pango Medical Electronics Co., Ltd | Shenzhen Guangdong, China | Manufacturer | 1 | April 3, 2019 | 0 | 0 | 0 | api.fda.gov |
| Solventum US LLC | Eden Prairie, MN, United States | Manufacturer, Repackager or relabeler | 1 | May 30, 2012 | 0 | 0 | 0 | api.fda.gov |
| Starboard Medical, Inc. | Irvine, CA, United States | Complaint file establishment, Specification developer | 1 | August 11, 2011 | 0 | 0 | 0 | api.fda.gov |
| SunMed Group Holdings, LLC | Grand Rapids, MI, United States | Specification developer | 1 | September 12, 1979 | 0 | 0 | 0 | api.fda.gov |
| T&R Biofab Co.,ltd. | Siheung-si Gyeonggi, South Korea | Manufacturer | 1 | December 5, 2023 | 0 | 0 | 0 | api.fda.gov |
| Taiwan Aulisa Medical Devices Technologies, Inc. | Taipei City, Taiwan | Manufacturer | 1 | September 27, 2024 | 0 | 0 | 0 | api.fda.gov |
| TE Sensores S. de R.L. de C.V | Hermosillo Mexico, Mexico | Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer | 1 | November 21, 1988 | 0 | 0 | 0 | api.fda.gov |
| Tidi Products, LLC | Neenah, WI, United States | Manufacturer | 1 | October 19, 1998 | 0 | 0 | 0 | api.fda.gov |
| Truer Medical, Inc. | Orange, CA, United States | Manufacturer | 1 | November 18, 2010 | 0 | 0 | 0 | api.fda.gov |
| Truly Instrument Limited | Kwai Chung, Hong Kong | Specification developer | 1 | June 24, 2009 | 0 | 0 | 0 | api.fda.gov |
| Twin River Group | Trenton, NJ, United States | Manufacturer | 1 | March 1, 2016 | 0 | 0 | 0 | api.fda.gov |
| Tytocare Ltd. | Netanya Central, Israel | Manufacturer | 1 | March 27, 2019 | 0 | 0 | 0 | api.fda.gov |
| Teleflex LLC (NADC) | Olive Branch, MS, United States | Manufacturer, Repackager or relabeler | 1 | December 13, 1977 | 0 | 0 | 0 | api.fda.gov |
| Teleflex Medical LLC | Morrisville, NC, United States | Complaint file establishment, Specification developer | 1 | December 13, 1977 | 0 | 0 | 0 | api.fda.gov |
| Teleflex Medical de Tecate, S. de R.L de C.V. | TECATE Baja California, Mexico | Manufacturer | 1 | December 13, 1977 | 0 | 0 | 0 | api.fda.gov |
| Tianjin Choice Medical Device Co., Ltd. | Tianjin, China | Contract manufacturer, Exporter to the US | 1 | January 21, 2022 | 0 | 0 | 0 | api.fda.gov |
| Unimed Medical Supplies Inc | Shenzhen Guangdong, China | Manufacturer | 1 | May 29, 2012 | 0 | 0 | 0 | api.fda.gov |
| Welch Allyn, Inc. | Skaneateles Falls, NY, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | March 1, 2016 | 0 | 1 | 0 | api.fda.gov |
| Wenzhou Yosun Medical Technology Co., Ltd. | Wenzhou Zhejiang, China | Contract manufacturer, Manufacturer | 1 | October 23, 2020 | 0 | 0 | 0 | api.fda.gov |
| Xuzhou Yongkang Electronic Science Technology Co., Ltd | Xuzhou Jiangsu, China | Manufacturer | 1 | July 11, 2018 | 0 | 0 | 0 | api.fda.gov |
| Zhongshan Jinli Electronic Weighing Equipment Co., Ltd. | Zhongshan Guangdong, China | Manufacturer | 1 | January 15, 2021 | 0 | 0 | 0 | api.fda.gov |
| Zhuhai Yueja Medical Device Technology Co., Ltd. | Zhuhai Guangdong, China | Manufacturer | 1 | February 9, 2024 | 0 | 0 | 0 | api.fda.gov |
| Zhuzhou Goldenhot Medical Technology Co.,Ltd | Zhuzhou Hunan, China | Manufacturer | 1 | April 12, 2024 | 0 | 0 | 0 | api.fda.gov |
| 3T Medical Systems Inc. | Edison, NJ, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Advanced Instrumentations, Inc. | Miami, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aidar Health, Inc | Columbia, MD, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Analog Devices | Wilmington, MA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Athena GTX | Johnston, IA, United States | Complaint file establishment, Manufacturer, Remanufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Becton, Dickinson And Company | Irvine, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| BENCHMARK ELECTRONICS San Jorge | Tlajomulco de Zuniga Jalisco, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Benchmark Electronics, Inc. | Winona, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Benchmark Electronics, Inc. | Rochester, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bernd Richter GMBH | Wipperfuerth North Rhine-Westphalia, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Betacera Inc. | Suzhou City Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biobeat Technologies Ltd | Petakh Tikva Central, Israel | Exporter to the US, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biomed Medequip Inc. | Rowlett, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bluepoint Medical GMBH & Co. KG | Selmsdorf Mecklenburg-Western Pomerania, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boluo Yuanzhou Dagao Electronics Co. Ltd. | P.R. CHINA Xinjiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Caf Medical Solutions Inc | Hockley, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CCT Critical Care Technologies, S.R.L. Also Trading As Edwards Lifesciences AG | HAINA San Cristobal, Dominican Republic | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Corsano Health B.V. | The Hague Zuid-Holland, Netherlands | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CPC Solutions | Karmiel Northern, Israel | 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 | |
| Corsano Health SA | Plan-les-Ouates Geneve, Switzerland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Covidien | Plainfield, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Current Health Ltd | Edinburgh Edinburgh, City of, United Kingdom | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Deroyal Cientifica De Latinoamerica S.R.L. | La Aurora, Heredia, Costa Rica | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dictum Health, Inc. | Malibu, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Digicare Biomedical Technology, Inc. | Boynton Beach, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Rongfeng Medical Co.,ltd | Dongguan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Draeger Medical Systems, Inc. | Andover, MA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dreamtech Co., Ltd. | Asan-si Chungnam, South Korea | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dreamtech Vietnam Co., Ltd | Tu Son Ward Bac Ninh, Vietnam | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dynamic Ems Ltd | Dalgety Bay Fife, United Kingdom | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan CFE Electronic Co., Ltd | Dongguan Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Draeger Interservices GmbH | Luebeck Schleswig-Holstein, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Easytem Co., Ltd | Siheung-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| EDAN Diagnostics, Inc. | San Diego, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Edan Instruments, Inc. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Edwards Lifesciences Technology Sarl | Anasco, PR, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Electronic Development Labs, Inc. | Danville, VA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Emi (dongguan) Asia Limited | Dongguan City Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| EMPATICA S.r.l. | Milano, Italy | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ever Ppe Inc | Sealy, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| East West Wisconsin | Whitewater, WI, 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 | |
| Famidoc Technology Co., Ltd | Dong Guan Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Flash Global | Lockbourne, OH, United States | Contract manufacturer, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Flextronics Manufacturing (Singapore) Pte Ltd | SINGAPORE South East, Singapore | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gamamed Vascular Systems Inc. | Loveland, CO, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ge Healthcare Finland OY | HELSINKI Uusimaa, Finland | Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ge Medical Systems (china) Co., Ltd. | WUXI Jiangsu, China | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ge Medical Systems Information Technologies | El Paso, TX, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| GE Medical Systems Information Technologies - Critikon de Mexico S. de R.L. de C.V. | JUAREZ Chihuahua, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GE Medical Systems Information Technologies, Inc. | Waukesha, WI, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GE Medical Systems Information Technologies, Inc. | Wauwatosa, WI, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangdong Biolight Meditech Co., Ltd | Zhuhai Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Happy Health | Austin, TX, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Health & Health (group) Co.,ltd | Guangzhou Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hochuen Medical Sdn. Bhd. | SENAI Johor, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hosmed Inc. | Doral, FL, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hochuen Medical Technology Co.,Ltd. | Shenzhen Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Infinium Medical, Inc. | Largo, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Intops Co.,ltd. | Suwon Gyeonggi, South Korea | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Inventech Xiamen Co., Ltd. | Xiamen Fujian, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ipax, Inc. | Englewood, CO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Itek | Cartago, Costa Rica | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Industrial Vallera de Mexicali, S.A. de C.V. (Terra) | Mexicali Baja California, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ionics EMS Inc. | Cabuyao City Laguna, Philippines | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ionics EMS, Inc-Plant 2 | Calamba City Laguna, Philippines | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| J Sterling Industries LLC | Kalamazoo, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangyin Sinbon Electronics Co Ltd | Jiangyin Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Just Keep Healthy Co., Ltd. | Samkkei Munichay District Kampong Speu, Cambodia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Key Tronic Viet Nam Company Limited | Da Nang, Vietnam | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Key-Tech Scotland Ltd | Dunfermline Fife, United Kingdom | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Key Tronic Corporation | Juarez Chihuahua, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Key Tronic Juarez, S.A de C.V. | Juarez Chihuahua, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kimball Electronics - Thailand LTD | Thungsukla Sriracha Chon Buri, Thailand | 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 | |
| Longcheer Meiko Electronics Vietnam Company Limited | Hanoi Ha Noi, Vietnam | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Luxshare - Ict (nghe An ) Limited | Nghe An, Vietnam | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LifeSignals India Private Limited | Bangalore Karnataka, India | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LifeSignals, Inc. | Milpitas, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Maquiladora De Coahuila S De RL De CV | CUIDAD ACUNA Coahuila, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medeia Group Ltd | Sofia Sofia-Grad, Bulgaria | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medwand Solutions, Inc | Rsm, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MINDRAY DS USA, Inc. | Mahwah, NJ, United States | Complaint file establishment, Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Minitube AB | TRANGSVIKEN Jamtland, Sweden | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Masimo Medical Technologies (Malaysia) SDN BHD | Pasir Gudang Johor, Malaysia | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtronic Mexico S. de R.L. de CV | Tijuana Baja California, Mexico | 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 | |
| Nonagon Ltd. | Caesarea Haifa, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| NextPhase Medical Devices, LLC | Mansfield, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nicolay GMBH | NAGOLD Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Osi Systems Pvt Ltd(optoelectronics Division) | HYDERABAD Telangana, India | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Physio-Control, Inc. | Redmond, WA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pulsion Medical Systems Se | Aschheim, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Philips France | Paris, France | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Philips Goldway (Shenzhen) Industrial Inc. | SHENZHEN Guangdong, China | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Philips Medical Systems Ltda | Varginha Minas Gerais, Brazil | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Philips Medizin Systeme Boeblingen GmbH | BOEBLINGEN Baden-Wurttemberg, Germany | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Philips North America LLC | Cambridge, MA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Philips North America LLC | Murrysville, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Philips North America LLC | Export, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Remote Diagnostic Technologies Ltd. | FARNBOROUGH Hampshire, United Kingdom | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Repair Operations Center | Oak Creek, WI, United States | Remanufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Seca | Hamburg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SEI Medical S.A. de C.V. | Juarez Chihuahua, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Comen Medical Instruments Co., Ltd. | Shenzhen Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Creative Industry Co., Ltd | SHENZHEN Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | Shenzhen Guangdong, China | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Mondial Technology Co., Ltd. | Shenzhen Guangdong, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sibel Health Inc. | Chicago, IL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Skanray Technologies Limited | Mysore Karnataka, India | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sotera Wireless | Carlsbad, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suntech Medical, Inc. | Morrisville, NC, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Supercomal Medical Products, Sdn Bhd | SUNGAI PETANI Kedah, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Mindray Bio-Medical Electronics Co.,LTD | SHENZHEN Guangdong, China | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siemens Healthineers AG | FORCHHEIM Bavaria, Germany | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Spacelabs Healthcare Inc. | Snoqualmie, WA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Starboard Medical (Jiangsu) Co. Ltd. | Sheyang Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Taidoc Technology Corporation | New Taipei City, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Telstar Vietnam Company Limited | Bac Ninh, Vietnam | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Toppan Teq LLC | Huntley, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tasco Medical Industries Co., Ltd. | Bao An District, Shenzhen Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Technical Services for Electronics, Inc. | New Taipei City, Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vitaldyne, Inc. | Cokato, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Well Lead Medical Co. Ltd | GUANGZHOU Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wipro Ge Medical Device Manufacturing Private Limited | Bangalore Karnataka, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wuhan Strong Electronics | Wuhan Hubei, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Hongyu Medical Commodity Co., Ltd. | YIWU Zhejiang, China | 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 | |
| Zoll Medical Corporation | Chelmsford, MA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated June 5, 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.