Data / Medical devices / United States / Levita Magnetics International Corp.
Levita Magnetics International Corp.: FDA-registered device maker in Mountain View, CA, United States, 2 510(k) clearances
Levita Magnetics International Corp. is registered with the FDA (registration 3012986524) in Mountain View, CA, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated August 4, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012986524
- Address
- 453 Ravendale Drive Suite G/H, Mountain View, CA, United States, 94043
- Owner or operator
- Levita Magnetics International Corp. (10052338)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- July 18, 2016
- Registered through
- 2026
- Brand names listed
- Fixed Arm System, Magnetic Controller, Magnetic Grasper Device, Magnetic Surgical System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Magnetic Surgical System | PNL | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Operating Room Accessories Table Tray | FWZ | 1 | Complaint file establishment | 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 |
|---|---|---|---|---|---|---|
| August 4, 2023 | K223673 | Surgeon Controlled Arm | PNL | Substantially Equivalent | Levita Magnetics International Corp | accessdata.fda.gov |
| June 13, 2016 | DEN150007 | Magnetic Surgical System | PNL | Unknown | Levita Magnetics International Corp | accessdata.fda.gov |
Compare with other makers
Updated August 4, 2023. 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.