Finemedix Co., Ltd. FDA Record
- No warning letters matched by name
Finemedix Co., Ltd. has 0 FDA recalls, 0 inspections, 11 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Finemedix Co., Ltd." is on file.
- Latest 510(k)
- Apr 16, 2026
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 11 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 0 | 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 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K251478 | ClearTip TBNA Type | Apr 16, 2026 |
| K250994 | ClearTip FNA and FNB Types | Aug 21, 2025 |
| K242857 | ClearHemograsper | May 21, 2025 |
| K242134 | ClearCap Distal Attachment | Aug 20, 2024 |
| K231267 | ClearTip | Jun 30, 2023 |
| K202616 | ClearCap Distal Attachment | Feb 19, 2021 |
| K200217 | ClearEndoclip | Oct 5, 2020 |
| K183021 | ClearEndoclip | Jun 28, 2019 |
| K183289 | ClearGrasp Snare | Mar 6, 2019 |
| K181690 | Clear-Jet Injection Catheter | Dec 21, 2018 |
| K180363 | Clear-Tip EUS-FNA | Nov 1, 2018 |
Finemedix Co., Ltd. and the FDA: common questions
Has Finemedix Co., Ltd. received an FDA warning letter?
No FDA warning letter addressed to the name "Finemedix 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 Finemedix Co., Ltd. received an FDA Form 483?
FDA has not published a Form 483 for "Finemedix Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.
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