Avent America, Inc. FDA Record
Avent America, Inc. has 0 FDA recalls, 0 inspections, 4 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Avent America, Inc." is on file.
- Latest 510(k)
- Sep 22, 2005
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 4 | 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 |
|---|---|---|
| K052047 | ISIS IQ UNO HANDHELD ELECTRONIC BREAST PUMP, MODEL 101 | Sep 22, 2005 |
| K051413 | ISIS IQ DUO TWIN ELECTRONIC BREAST PUMP, MODEL 100 | Aug 29, 2005 |
| K952035 | NIPLETTE | Jul 28, 1995 |
| K944117 | AVENT NIPPLE SHIELD | Oct 5, 1994 |
Avent America, Inc. and the FDA: common questions
Has Avent America, Inc. received an FDA warning letter?
No FDA warning letter addressed to the name "Avent America, 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 Avent America, Inc. received an FDA Form 483?
FDA has not published a Form 483 for "Avent America, Inc." in its reading room. FDA publishes some Form 483s, not all of them.
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