Data / Medical devices / United States / Lineage Biomedical, Inc
Lineage Biomedical, Inc: FDA-registered device maker in Stuart, FL, United States, 1 510(k) clearance
Lineage Biomedical, Inc is registered with the FDA (registration 3030201489) in Stuart, FL, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 30, 2023. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3030201489
- Address
- 620 NW Dixie Hwy, Stuart, FL, United States, 34994
- Owner or operator
- Lineage Biomedical, Inc (10089727)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- January 2, 2024
- Registered through
- 2026
- Brand names listed
- NavaClick Injection System, NavaClick Syringe and Needle
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Needle, Hypodermic, Single Lumen | FMI | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Set, I.V. Fluid Transfer | LHI | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| November 30, 2023 | K231877 | NavaClick Injection System | FMF | Substantially Equivalent | Lineage Biomedical, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 12, 2024 | 94963 | Class III | Ongoing | NavaClick Syringe and Needle, Model Number LIN02 | Incorrect GTIN number on carton. | accessdata.fda.gov |
Compare with other makers
- All makers of Syringe, Piston
- All makers of Set, I.V. Fluid Transfer
- All makers of Needle, Hypodermic, Single Lumen
Updated August 8, 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.