Bloom Surgical, Inc. FDA Record
- No warning letters matched by name
Bloom Surgical, Inc. has 0 FDA recalls, 0 inspections, 1 510(k) clearance and 0 compliance actions on record. No FDA warning letter addressed to "Bloom Surgical, Inc." is on file.
- Latest 510(k)
- Oct 29, 2026
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 | 1 | 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 |
|---|---|---|
| K263459 | SWICS | Oct 29, 2026 |
Bloom Surgical, Inc. and the FDA: common questions
Has Bloom Surgical, Inc. received an FDA warning letter?
No FDA warning letter addressed to the name "Bloom Surgical, Inc." 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 Bloom Surgical, Inc. received an FDA Form 483?
FDA has not published a Form 483 for "Bloom Surgical, Inc." in its reading room. FDA publishes some Form 483s, not all of them.
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