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United States·US-MF-000003939
Last updated September 17, 2026
What XODUS MEDICAL, INC. makes
Xodus Medical, Inc. manufactures single-use procedural medication labeling sets, operating table patient positioning sets, freestanding patient positioners, monopolar electrosurgical electrodes for open surgery, sharp surgical instrument counting trays or pads, skin marking pens, operating room turnover kits, and reusable operating table patient pressure distribution pads.
The company's devices are classified as Class I and Class II medical devices and are listed in the FDA's Unique Device Identification (fda_udi) registry. Xodus Medical, Inc. is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Xodus Medical, Inc. manufacture?
Xodus Medical, Inc. manufactures procedural medication labeling sets, operating table patient positioning sets, freestanding patient positioners, monopolar electrosurgical electrodes for open surgery, sharp surgical instrument counting trays or pads, skin marking pens, operating room turnover kits, and reusable operating table patient pressure distribution pads. These products are designed for single-use or reusable applications in surgical and procedural settings, as specified in the device data.
Where is Xodus Medical, Inc. based?
Xodus Medical, Inc. is based in the United States, as explicitly stated in the device data under the COUNTRY field and confirmed in the SUMMARY section, which notes the company's location without referencing any specific city, state, or facility details beyond the country level.
In which regulatory registry are Xodus Medical, Inc.'s devices listed?
Xodus Medical, Inc.'s devices are listed in the FDA's Unique Device Identification (fda_udi) registry, as indicated in the LISTED IN field and reiterated in the SUMMARY, which confirms the company's devices are included in this specific U.S. regulatory system for device tracking and identification.
How are Xodus Medical, Inc.'s devices classified under regulatory frameworks?
Xodus Medical, Inc.'s devices are classified as Class I and Class II medical devices, according to the DEVICE CLASSES field in the provided data. This classification reflects the risk-based regulatory categorization used by the FDA, where Class I devices are low-risk and Class II devices require special controls, but neither classification implies approval or clearance of the company itself.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 702, Prominence Drive, New Kensington, United States
- Website
- www.xodusmedical.com
- —
- —
- [email protected]
- Phone
- 7243375500
- PRRC Contact
- Paul Lloyd
- EUDAMED SRN
- US-MF-000003939
- FDA FEI Number
- 1000221205
- DUNS Number
- 868042664
Catalogue (3442)
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FDA Recalls (3)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
The FDA recall records for Xodus Medical, Inc. show 3 recall records. The earliest and most recent recall records were both initiated on 2019-09-19. All recalls have a status of terminated. The reasons given for the recalls include that the sterile barrier of some devices may have been affected.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Sep 19, 2019 | Z-0150-2020 | — | terminated | The sterile barrier of some devices may have been affected |
| Sep 19, 2019 | Z-0151-2020 | — | terminated | The sterile barrier of some devices may have been affected |
| Sep 19, 2019 | Z-0149-2020 | — | terminated | The sterile barrier of some devices may have been affected |