Data / Medical devices / United States / Rejoni, Inc
Rejoni, Inc: FDA-registered device maker in Bedford, MA, United States, 1 510(k) clearance and 1 PMA approval
Rejoni, Inc is registered with the FDA (registration 3033307563) in Bedford, MA, United States. It lists 2 device types. The FDA files 1 510(k) clearance and 1 PMA approval under its listings, the newest dated September 28, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3033307563
- Address
- 201 Burlington Rd, Bedford, MA, United States, 01730
- Owner or operator
- Rejoni, Inc (10091756)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- October 30, 2024
- Registered through
- 2026
- Brand names listed
- Juveena Hydrogel System, Rejoni Acorn Catheter
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Barrier, Absorbable, Adhesion | MCN | 3 | Manufacturer | accessdata.fda.gov |
| Cannula, Manipulator/Injector, Uterine | LKF | 2 | 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 |
|---|---|---|---|---|---|---|
| December 16, 2022 | K222798 | Rejoni Intrauterine Catheter | LKF | Substantially Equivalent | Rejoni, Inc. | 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 |
|---|---|---|---|---|---|---|
| September 28, 2026 | P250051 | Juveena Hydrogel System | MCN | 0 | September 28, 2026 | accessdata.fda.gov |
Compare with other makers
Updated September 28, 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.