Nomax Inc

FDA Regulatory Profile

Summary

Total Recalls
8
510(k) Clearances
1
Inspections
9
Compliance Actions
1

Recent Recalls

NumberClassProductDate
D-0462-2024Class IIGloStrips, Fluorescein Sodium Ophthalmic Strips USP (0.6 mg Fluorescein), Rx Only, a) 100 strips perApril 19, 2024
D-0464-2024Class IIFUL-GLO, Fluorescein Sodium Sterile Ophthalmic Strips USP (0.6 mg Fluorescein), 300 sterile strips pApril 19, 2024
D-0465-2024Class IIFUL-GLO, Fluorescein Sodium Ophthalmic Strips USP 1 mg, 100 sterile strips per carton, Manufactured April 19, 2024
D-0463-2024Class IIGloStrips, Fluorescein Sodium Ophthalmic Strips USP (1.0 mg Fluorescein), Rx Only, 100 Sterile StripApril 19, 2024
D-0387-2021Class IIIDry Eye Test, Fluorescein Sodium, Ophthalmic Strips USP (0.12mg Fluorescein Sodium), 100 Sterile StrApril 13, 2021
D-0962-2015Class IIIRose Bengal GloStrips (rose bengal) Ophthalmic Strips USP, 1.3 mg per strip, individually wrapped stMarch 24, 2015
D-0963-2015Class IIIFluorescein Sodium Ophthalmic Strips USP, 1.0 mg per strip, labeled as 1) FUL-GLO, individually wrapMarch 24, 2015
D-0961-2015Class IIIFluorescein Sodium Ophthalmic Strips USP, 0.6 mg per strip, labeled as 1) Fluorescein GloStrips, indMarch 24, 2015

Recent 510(k) Clearances

K-NumberDeviceDate
K923458CONTACT LENS CASEMay 12, 1993