Data / Medical devices / United States / Imbed Biosciences Inc.
Imbed Biosciences Inc.: FDA-registered device maker in Middleton, WI, United States, 2 510(k) clearances
Imbed Biosciences Inc. is registered with the FDA (registration 3013478891) in Middleton, WI, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated October 17, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013478891
- Address
- 2241 Pinehurst Dr, Middleton, WI, United States, 53562
- Owner or operator
- Imbed Biosciences Inc. (10053164)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- November 6, 2016
- Registered through
- 2026
- Brand names listed
- Microlyte Ag/Lidocaine, Microlyte PainGuard, MicrolyteAg, Microlyte® Matrix, Pelashield PainGuard, PelashieldAMTM, Surgaflex PainGuard, SurgaflexTM
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dressing, Wound, Drug | FRO | U | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| October 17, 2024 | K211943 | Microlyte Ag/Lidocaine | FRO | Substantially Equivalent | Imbed Biosciences | accessdata.fda.gov |
| August 4, 2016 | K153756 | Microlyte Ag | FRO | Substantially Equivalent | Imbed Biosciences, Inc. | accessdata.fda.gov |
Compare with other makers
Updated October 17, 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.