Data / Medical devices / United States / Congruence Medical Solutions, LLC
Congruence Medical Solutions, LLC: FDA-registered device maker in Baltimore, MD, United States, 1 510(k) clearance
Congruence Medical Solutions, LLC is registered with the FDA (registration 3014623935) in Baltimore, MD, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 20, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014623935
- Address
- 3000 Falls Rd Ste 200a, Baltimore, MD, United States, 21211
- Owner or operator
- Congruence Medical Solutions, LLC (10096283)
- Roles
- Specification developer
- First device listed
- August 20, 2026
- Registered through
- 2026
- Brand names listed
- Microliter Dosing Syringe
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Ophthalmic Syringe | QLY | 2 | Specification developer | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| December 20, 2024 | K243149 | Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models) | QLY | Substantially Equivalent | Congruence Medical Solutions, LLC | accessdata.fda.gov |
Compare with other makers
Updated December 20, 2024. 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.