Data / Medical devices / United States / Lazarus 3D, Inc.
Lazarus 3D, Inc.: FDA-registered device maker in Philomath, OR, United States, 2 510(k) clearances
Lazarus 3D, Inc. is registered with the FDA (registration 3020858025) in Philomath, OR, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated May 26, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3020858025
- Address
- Lazarus 3D, Inc. 620 Applegate St., Philomath, OR, United States, 97370
- Owner or operator
- Lazarus 3D, Inc. (10083246)
- Roles
- Manufacturer
- First device listed
- November 4, 2021
- Registered through
- 2026
- Brand names listed
- Preoperative Surgical Rehearsal (Pre-Sure)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | 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 |
|---|---|---|---|---|---|---|
| May 26, 2023 | K230044 | Pre-Sure | LLZ | Substantially Equivalent | Lazarus 3D | accessdata.fda.gov |
| July 8, 2021 | K201835 | PRE-SURE | LLZ | Substantially Equivalent | Lazarus 3D, Inc. | accessdata.fda.gov |
Compare with other makers
Updated May 26, 2023. 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.