Data / Medical devices / United States / Heraeus Medical LLC - Bioresobables
Heraeus Medical LLC - Bioresobables: FDA-registered device maker in Yardley, PA, United States, 1 510(k) clearance
Heraeus Medical LLC - Bioresobables is registered with the FDA (registration 3019403037) in Yardley, PA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated May 16, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3019403037
- Address
- 770 Township Line Rd Ste 300, Yardley, PA, United States, 19067
- Owner or operator
- Heraeus Medical LLC - Bioresobables (10093722)
- Roles
- Specification developer
- First device listed
- June 27, 2025
- Registered through
- 2026
- Brand names listed
- Synthecure
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Filler, Bone Void, Calcium Compound | MQV | 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 |
|---|---|---|---|---|---|---|
| May 16, 2025 | K250141 | Synthecure Synthetic Calcium Sulfate | MQV | Substantially Equivalent | Austin Medical Ventures, Inc. | accessdata.fda.gov |
Compare with other makers
Updated May 16, 2025. 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.