Bomtech Electronics Co., Ltd. FDA Record
- No warning letters matched by name
Bomtech Electronics Co., Ltd. has 0 FDA recalls, 0 inspections, 2 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Bomtech Electronics Co., Ltd." is on file.
- Latest 510(k)
- Apr 7, 2025
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 11, 2026 (checked Nov 15, 2026, unchanged) | File dated Nov 10, 2026 | Current |
| 510(k) clearances | 2 | Nov 15, 2026 | File dated Nov 9, 2026 | Current |
| Inspections | 0 | Nov 15, 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 |
|---|---|---|
| K243143 | E-PEN (E-PEN) | Apr 7, 2025 |
| K243097 | RM STAR EX with RMS Needle | Dec 26, 2024 |
Bomtech Electronics Co., Ltd. and the FDA: common questions
Has Bomtech Electronics Co., Ltd. received an FDA warning letter?
No FDA warning letter addressed to the name "Bomtech Electronics 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 Bomtech Electronics Co., Ltd. received an FDA Form 483?
FDA has not published a Form 483 for "Bomtech Electronics Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.
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