Data / Medical devices / Accessories, Pump, Infusion / United States
FDA-registered makers of Accessories, Pump, Infusion in the United States: 13 establishments
13 establishments in the United States are registered with the FDA to make Accessories, Pump, Infusion (product code MRZ). 8 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.
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- Device
- Accessories, Pump, Infusion
- Product code
- MRZ
- Country
- United States
Makers of Accessories, Pump, Infusion in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Icu Medical, Inc. | Lake Forest, IL, United States | Complaint file establishment, Specification developer | 4 | August 25, 2017 | 0 | 2 | 0 | api.fda.gov |
| American I.V. Products, Inc. | Harmans, MD, United States | Manufacturer | 2 | December 18, 2014 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Minimed | Northridge, CA, United States | Complaint file establishment, Manufacturer | 2 | October 17, 2007 | 0 | 0 | 0 | api.fda.gov |
| Welldoc | Columbia, MD, United States | Manufacturer | 2 | April 7, 2020 | 0 | 0 | 0 | api.fda.gov |
| B. Braun Medical Inc. | Bethlehem, PA, United States | Specification developer | 1 | August 2, 2018 | 0 | 0 | 0 | api.fda.gov |
| Carelife (usa) Inc. | Alpharetta, GA, United States | Specification developer | 1 | March 26, 2021 | 0 | 0 | 0 | api.fda.gov |
| Elite Biomedical Solutions LLC | Cincinnati, OH, United States | Manufacturer | 1 | April 29, 2022 | 0 | 0 | 0 | api.fda.gov |
| Ivwatch, LLC | Newport News, VA, United States | Manufacturer | 1 | February 13, 2015 | 0 | 0 | 0 | api.fda.gov |
| Bound Tree Medical, LLC | Grand Prairie, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MOMENI ENGINEERING dba Essex Industries | Huntington Beach, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Plexus Corp. | Neenah, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tandem Diabetes Care, Inc. | San Diego, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tandem Diabetes Care, INC. | San Diego, CA, United States | Manufacturer, Remanufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 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.