Nomax Inc
FDA Regulatory Profile
Nomax Inc appears in FDA public data with 8 recalls, 1 510(k) clearance, 10 FDA inspections, and 1 compliance action on record. Its most recent recall (D-0465-2024, Class II) was initiated on April 19, 2024. Its most recent 510(k) clearance was granted on May 12, 1993.
Summary
- Total Recalls
- 8
- 510(k) Clearances
- 1
- Inspections
- 10
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-0465-2024 | Class II | FUL-GLO, Fluorescein Sodium Ophthalmic Strips USP 1 mg, 100 sterile strips per carton, Manufactured | April 19, 2024 |
| D-0463-2024 | Class II | GloStrips, Fluorescein Sodium Ophthalmic Strips USP (1.0 mg Fluorescein), Rx Only, 100 Sterile Strip | April 19, 2024 |
| D-0464-2024 | Class II | FUL-GLO, Fluorescein Sodium Sterile Ophthalmic Strips USP (0.6 mg Fluorescein), 300 sterile strips p | April 19, 2024 |
| D-0462-2024 | Class II | GloStrips, Fluorescein Sodium Ophthalmic Strips USP (0.6 mg Fluorescein), Rx Only, a) 100 strips per | April 19, 2024 |
| D-0387-2021 | Class III | Dry Eye Test, Fluorescein Sodium, Ophthalmic Strips USP (0.12mg Fluorescein Sodium), 100 Sterile Str | April 13, 2021 |
| D-0961-2015 | Class III | Fluorescein Sodium Ophthalmic Strips USP, 0.6 mg per strip, labeled as 1) Fluorescein GloStrips, ind | March 24, 2015 |
| D-0963-2015 | Class III | Fluorescein Sodium Ophthalmic Strips USP, 1.0 mg per strip, labeled as 1) FUL-GLO, individually wrap | March 24, 2015 |
| D-0962-2015 | Class III | Rose Bengal GloStrips (rose bengal) Ophthalmic Strips USP, 1.3 mg per strip, individually wrapped st | March 24, 2015 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K923458 | CONTACT LENS CASE | May 12, 1993 |