Data / Medical devices / United States / Medennium, Inc.
Medennium, Inc.: FDA-registered device maker in Irvine, CA, United States, 1 510(k) clearance
Medennium, Inc. is registered with the FDA (registration 2031959) in Irvine, CA, United States. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 18, 2002. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2031959
- FEI number
- 3002777043
- Address
- 9 Parker, Suite 150, Irvine, CA, United States, 92618
- Owner or operator
- MEDENNIUM, INC. (9040473)
- Roles
- Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer
- First device listed
- November 29, 2007
- Registered through
- 2026
- Brand names listed
- Focus Acrylic, Focus Acrylic eclipse, MPL Manipulator, Matrix Acrylic, Matrix Acrylic Aurium, Medennium Phakic Lens (MPL), SmartPlug
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Hook, Ophthalmic | HNQ | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Intraocular Lens | HQL | 3 | Manufacturer for export | accessdata.fda.gov |
| Plug, Punctum | LZU | U | Manufacturer | accessdata.fda.gov |
| Spatula, Ophthalmic | HND | 1 | Repackager or relabeler, 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 |
|---|---|---|---|---|---|---|
| October 18, 2002 | K022043 | SMART PLUG, MODEL 500; SMARTPLUG FORCEPS, MODEL 502; PUSH ROD, MODEL 503 | LZU | Substantially Equivalent | Medennium, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Spatula, Ophthalmic
- All makers of Hook, Ophthalmic
- All makers of Plug, Punctum
- All makers of Intraocular Lens
Updated October 18, 2002. 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.