Shanghai Xodus Medical Company Limited FDA Record
Shanghai Xodus Medical Company Limited has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Shanghai Xodus Medical Company Limited" is on file.
- Latest inspection
- Jul 11, 2019 · OAI
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 1 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jul 11, 2019 | Shanghai, China | Devices | Official Action Indicated (OAI) | 3010380518 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3010380518 | Shanghai, China | 1 | Jul 11, 2019 |
Shanghai Xodus Medical Company Limited and the FDA: common questions
Has Shanghai Xodus Medical Company Limited received an FDA warning letter?
No FDA warning letter addressed to the name "Shanghai Xodus Medical Company Limited" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Shanghai Xodus Medical Company Limited received an FDA Form 483?
FDA has not published a Form 483 for "Shanghai Xodus Medical Company Limited" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Shanghai Xodus Medical Company Limited?
The most recent FDA inspection on file ended Jul 11, 2019 at Shanghai, China and was classified OAI. FDA has 1 inspection of Shanghai Xodus Medical Company Limited on file, 1 of them classified OAI (official action indicated).
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