Data / Medical devices / United States / Lung Bioengineering Inc
Lung Bioengineering Inc: FDA-registered device maker in Silver Spring, MD, United States, 1 PMA approval
Lung Bioengineering Inc is registered with the FDA (registration 3013113864) in Silver Spring, MD, United States. It lists 1 device type. The FDA files 1 PMA approval under its listings, the newest dated June 22, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013113864
- Address
- 1015 Spring St # Lb1, Silver Spring, MD, United States, 20910
- Owner or operator
- Lung Bioengineering Inc (10096227)
- Roles
- Manufacturer
- First device listed
- July 30, 2026
- Registered through
- 2026
- Brand names listed
- LungFX Device
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs | PHO | 3 | Manufacturer | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| June 22, 2026 | P240033 | LungFX device | PHO | 2 | October 16, 2026 | accessdata.fda.gov |
Compare with other makers
Updated October 16, 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.