Data / Medical devices / United States / Elite Biomedical Solutions LLC
Elite Biomedical Solutions LLC: FDA-registered device maker in Cincinnati, OH, United States, 1 510(k) clearance
Elite Biomedical Solutions LLC is registered with the FDA (registration 3009712113) in Cincinnati, OH, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated April 29, 2022. 1 recall event names it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009712113
- Address
- 756 Cincinnati Batavia Pike Ste C, Cincinnati, OH, United States, 45245
- Owner or operator
- Elite Biomedical Solutions LLC (10041252)
- Roles
- Manufacturer
- First device listed
- May 10, 2022
- Registered through
- 2026
- Brand names listed
- Elite Biomedical Solutions Dose Request Cord
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Pump, Infusion | MRZ | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 29, 2022 | K220695 | Elite Biomedical Solutions Dose Request Cord | MRZ | Substantially Equivalent | Elite Biomedical Solutions | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 3, 2015 | 71543 | Class I | Terminated | Alaris Medley LVP Frame Membrane. Intended use to hold platen assembly and help protect the bezel assembly's internal components from fluid intrusion. This part is used in the Alaris Medley LVP 8100 infusion pump. | Administration of inappropriate quantities of fluid can result, with the potential to cause injury or death. | accessdata.fda.gov |
Compare with other makers
Updated April 29, 2022. 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.