Data / Medical devices / Transducer, Blood-Pressure, Extravascular
Transducer, Blood-Pressure, Extravascular (DRS): 41 FDA-registered makers in 14 countries
41 establishments in 14 countries are registered with the FDA to make Transducer, Blood-Pressure, Extravascular (product code DRS, Class 2, 21 CFR 870.2850). 23 of them have a 510(k) clearance or PMA approval on file and 5 have a recall event. The FDA has issued 149 510(k) clearances under this code, the latest on September 10, 2026, and lists 12 recall events (1 Class I). FDA data exported November 2, 2026.
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- Product code
- DRS
- Device class
- 2
- Regulation
- 870.2850
- Medical specialty
- Cardiovascular
Makers by country
| Country | Makers |
|---|---|
| United States | 16 |
| China | 6 |
| Mexico | 4 |
| Germany | 3 |
| Singapore | 2 |
| Israel | 2 |
| Dominican Republic | 1 |
| Norway | 1 |
| Costa Rica | 1 |
| Brazil | 1 |
| Romania | 1 |
| India | 1 |
| Malaysia | 1 |
| Ireland | 1 |
Makers of Transducer, Blood-Pressure, Extravascular
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 |
|---|---|---|---|---|---|---|---|---|
| Icu Medical, Inc. | San Clemente, CA, United States | Complaint file establishment, Specification developer | 5 | November 9, 2017 | 0 | 4 | 0 | api.fda.gov |
| ICU Medical Healthcare Manufacturing S.A. de C.V. | APODACA Nuevo Leon, Mexico | Manufacturer, Repackager or relabeler | 5 | November 9, 2017 | 0 | 0 | 0 | api.fda.gov |
| Bioptimal International Pte. Ltd. | SINGAPORE South East, Singapore | Manufacturer | 4 | April 19, 2007 | 0 | 0 | 0 | api.fda.gov |
| Centurion Medical Products, LP | Williamston, MI, United States | Specification developer | 4 | November 22, 2016 | 0 | 0 | 0 | api.fda.gov |
| Icu Medical, Inc | Salt Lake City, UT, United States | Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer | 4 | September 19, 2006 | 0 | 0 | 0 | api.fda.gov |
| Medline Industries (NAMIC Division) - Glen Falls | Glens Falls, NY, United States | Manufacturer | 4 | March 25, 1996 | 0 | 0 | 0 | api.fda.gov |
| Tri-State De Mexico, S. De R.L. De C.V. | MEXICALI Baja California, Mexico | Manufacturer | 4 | November 22, 2016 | 0 | 0 | 0 | api.fda.gov |
| Becton, Dickinson And Company | Irvine, CA, United States | Specification developer | 3 | March 21, 2025 | 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 | 3 | March 21, 2025 | 0 | 0 | 0 | api.fda.gov |
| ICU MEDICAL DE MEXICO, S. de R.L. de C.V. | ENSENADA, Baja California, Mexico | Contract manufacturer, Manufacturer, Repackager or relabeler | 3 | September 19, 2006 | 0 | 0 | 0 | api.fda.gov |
| ICU Medical, Inc. | Dublin, OH, United States | Manufacturer | 3 | June 27, 1996 | 0 | 1 | 0 | api.fda.gov |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Specification developer | 2 | May 8, 2013 | 0 | 2 | 1 | api.fda.gov |
| Merit Medical Singapore Pte. Ltd. | SINGAPORE Central Singapore, Singapore | Manufacturer | 2 | February 26, 1986 | 0 | 0 | 0 | api.fda.gov |
| Utah Medical Products, Inc. | Midvale, UT, United States | Manufacturer | 2 | March 25, 1985 | 0 | 1 | 0 | api.fda.gov |
| Covidien | TIJUANA, B.C. Mexico, Mexico | Manufacturer | 1 | July 14, 1980 | 0 | 0 | 0 | api.fda.gov |
| Covidien | Lafayette, CO, United States | Specification developer | 1 | July 14, 1980 | 0 | 0 | 0 | api.fda.gov |
| Edwards Lifesciences Technology Sarl | Anasco, PR, United States | Manufacturer | 1 | March 21, 2025 | 0 | 0 | 0 | api.fda.gov |
| Hosmed Inc. | Doral, FL, United States | Manufacturer, Repackager or relabeler | 1 | February 5, 1999 | 0 | 0 | 0 | api.fda.gov |
| Memscap AS | SKOPPUM Vestfold, Norway | Manufacturer | 1 | December 7, 1979 | 0 | 0 | 0 | api.fda.gov |
| Merit Medical Systems, Inc. | South Jordan, UT, United States | Manufacturer | 1 | December 11, 1992 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Antmed Co. Ltd | Dongguan Guangdong, China | Manufacturer | 1 | August 18, 2009 | 0 | 0 | 0 | api.fda.gov |
| Terumo Cardiovascular Costa Rica LLC | Zona Franca La Lima Cartago, Costa Rica | Manufacturer | 1 | December 10, 2009 | 0 | 0 | 0 | api.fda.gov |
| Zhejiang Haisheng Medical Device Co., Ltd. | Shaoxing Zhejiang, China | Manufacturer | 1 | October 31, 2016 | 0 | 0 | 0 | api.fda.gov |
| Argon Medical Devices Inc. | Athens, TX, United States | Contract manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bioxin Medical Co., Ltd | Weihai Shandong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Elcam Medical A.C.A.L. | D.N. MEROM HAGALIL Northern, Israel | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Elcam Medical Acal | DALTON INDUSTRIAL PARK, P.O BOX 9 Northern, Israel | Contract manufacturer | 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 | |
| Nicolay GMBH | NAGOLD Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pulsion Medical Systems Se | Aschheim, Germany | Contract manufacturer | 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 | Andover, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quest Medical, Inc. | Allen, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SC Euromedica SRL | Iasi, Romania | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | Shenzhen Guangdong, China | 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 | |
| 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 | |
| Utah Medical Products, Ltd. | ATHLONE CO. Leinster, Ireland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 10, 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.