XuZhou Kernel Medical Instrument Equipment Co. Ltd FDA Record
XuZhou Kernel Medical Instrument Equipment Co. Ltd has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "XuZhou Kernel Medical Instrument Equipment Co. Ltd" is on file.
- Latest inspection
- Jun 5, 2025 · NAI
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 | 2 | 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 |
|---|---|---|---|---|
| Jun 5, 2025 | Xuzhou, China | Devices | No Action Indicated (NAI) | 3008393409 |
| Nov 12, 2015 | Xuzhou, China | Devices | Voluntary Action Indicated (VAI) | 3008393409 |
- 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 3008393409 | Xuzhou, China | 2 | Jun 5, 2025 |
XuZhou Kernel Medical Instrument Equipment Co. Ltd and the FDA: common questions
Has XuZhou Kernel Medical Instrument Equipment Co. Ltd received an FDA warning letter?
No FDA warning letter addressed to the name "XuZhou Kernel Medical Instrument Equipment Co. Ltd" 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 XuZhou Kernel Medical Instrument Equipment Co. Ltd received an FDA Form 483?
FDA has not published a Form 483 for "XuZhou Kernel Medical Instrument Equipment Co. Ltd" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect XuZhou Kernel Medical Instrument Equipment Co. Ltd?
The most recent FDA inspection on file ended Jun 5, 2025 at Xuzhou, China and was classified NAI. FDA has 2 inspections of XuZhou Kernel Medical Instrument Equipment Co. Ltd on file.
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