Samsung HME America, Inc., Dba NeuroLogica Corp. FDA Record
- No warning letters matched by name
Samsung HME America, Inc., Dba NeuroLogica Corp. has 0 FDA recalls, 0 inspections, 1 510(k) clearance and 0 compliance actions on record. No FDA warning letter addressed to "Samsung HME America, Inc., Dba NeuroLogica Corp." is on file.
- Latest 510(k)
- Sep 22, 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 |
|---|---|---|
| K261125 | BodyTom 64 (NL4100); OmniTom Elite (NL5000) | Sep 22, 2026 |
Samsung HME America, Inc., Dba NeuroLogica Corp. and the FDA: common questions
Has Samsung HME America, Inc., Dba NeuroLogica Corp. received an FDA warning letter?
No FDA warning letter addressed to the name "Samsung HME America, Inc., Dba NeuroLogica Corp." 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 Samsung HME America, Inc., Dba NeuroLogica Corp. received an FDA Form 483?
FDA has not published a Form 483 for "Samsung HME America, Inc., Dba NeuroLogica Corp." in its reading room. FDA publishes some Form 483s, not all of them.
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