Data / Medical devices / Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System / United States
FDA-registered makers of Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System in the United States: 10 establishments
10 establishments in the United States are registered with the FDA to make Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System (product code ONB). 6 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 2, 2026.
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- Device
- Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
- Product code
- ONB
- Country
- United States
Makers of Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Becton Dickinson | Franklin Lakes, NJ, United States | Specification developer | 6 | September 12, 2025 | 0 | 1 | 0 | api.fda.gov |
| Equashield LLC | Port Washington, NY, United States | Manufacturer, Repackager or relabeler | 3 | February 17, 2023 | 0 | 0 | 0 | api.fda.gov |
| Icu Medical, Inc | Salt Lake City, UT, United States | Manufacturer, Specification developer | 2 | August 10, 2018 | 0 | 0 | 0 | api.fda.gov |
| Carefusion | San Diego, CA, United States | Specification developer | 1 | March 24, 2023 | 0 | 0 | 0 | api.fda.gov |
| Icu Medical, Inc. | San Clemente, CA, United States | Specification developer | 1 | August 31, 2018 | 0 | 9 | 1 | api.fda.gov |
| Yukon Medical, LLC | Durham, NC, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | March 2, 2021 | 0 | 0 | 0 | api.fda.gov |
| Becton Dickinson Infusion Therapy Systems Inc. | Sandy, UT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Comar LLC | Woodville, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Robling Medical, LLC | Youngsville, NC, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vault Paragon Group, Inc. | Garden City, ID, United States | Contract manufacturer | 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.