Data / Medical devices / United States / Moximed, Inc.
Moximed, Inc.: FDA-registered device maker in Fremont, CA, United States, 1 510(k) clearance
Moximed, Inc. is registered with the FDA (registration 3008274656) in Fremont, CA, United States. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 10, 2023. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008274656
- Address
- 46602 Landing Parkway, Fremont, CA, United States, 94538
- Owner or operator
- Moximed, Inc. (10031357)
- Roles
- Manufacturer
- First device listed
- April 17, 2023
- Registered through
- 2026
- Brand names listed
- MISHA(TM) Knee System, MISHA(TM) Knee System Fixation Kit, MISHA(TM) Knee System Targeting Kit, MISHA(TM) Knee System Torque Limiting Driver, MISHA(TM) Knee System Trial
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Driver, Prosthesis | HWR | 1 | Manufacturer | accessdata.fda.gov |
| Medial Knee Implanted Shock Absorber | QVV | 2 | Manufacturer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Manufacturer | accessdata.fda.gov |
| Template | HWT | 1 | 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 |
|---|---|---|---|---|---|---|
| April 10, 2023 | DEN220033 | MISHA Knee System | QVV | Unknown | Moximed, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 2, 2024 | 95887 | Class II | Ongoing | MISHA Knee System Implant Small, Left, REF: 2-1001. MISHA Knee System Implant Small, Right, REF: 2-1002. | Knee implant may fracture due to a supplier-related issue with one component that has nonconforming geometry at the distal end of the absorber component that may result in a reduced wall thickness and microcracks, which may lead to new or worsening symptoms of discomfort, swelling / edema, pain or stiffness, which may necessitate removal of the device. | accessdata.fda.gov |
Compare with other makers
- All makers of Driver, Prosthesis
- All makers of Orthopedic Manual Surgical Instrument
- All makers of Template
Updated December 23, 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.