Medtech Products, Inc.

FDA Regulatory Profile

Summary

Total Recalls
18
510(k) Clearances
14
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-1828-2019Class IIClear Eyes Assorted Sidekick Floor Stand Display; each display contains 6 each of a) Clear eyes REDNJuly 26, 2019
D-1835-2019Class IIClear Eyes Redness Relief Hand Pocket Pal Tray Display; each display (UPC 6 78112 25418 7) contains July 26, 2019
D-1832-2019Class IIClear Eyes Maximum Itchy Eye Relief Sidekick Floor Stand Display; each display (case UPC 10678112736July 26, 2019
D-1826-2019Class IIClear Eyes Assorted IRC Display; each display contains 6 each of a) Clear eyes REDNESS RELIEF (GlyceJuly 26, 2019
D-1822-2019Class IIClear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops, packaged in July 26, 2019
D-1833-2019Class IIClear Eyes Redness Relief Handy Pocket Pal Club Pak Display; each display (case UPC 30300742541283) July 26, 2019
D-1834-2019Class IIClear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops, Handy PocketJuly 26, 2019
D-1829-2019Class IIClear Eyes Redness Relief Club Pack Display; each display contains 18 3-Pack bottles (UPC 6 78112 10July 26, 2019
D-1831-2019Class IIClear Eyes Maximum Redness Relief Club Pack Display; each display contains 18 3-Pack bottles (UPC 6 July 26, 2019
D-1830-2019Class IIClear Eyes Maximum Itchy Eye Relief Sidekick Floor Stand Display; each display contains 12 each of CJuly 26, 2019
D-1825-2019Class IIClear eyes MAXIMUM REDNESS RELIEF (Glycerin 0.5%, Naphazoline hydrochloride 0.03%) eye drops, 0.5 FLJuly 26, 2019
D-1824-2019Class IIClear eyes MAXIMUM ITCHY EYE RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%, Zinc Sulfate July 26, 2019
D-1823-2019Class IIClear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops, Handy PocketJuly 26, 2019
D-1827-2019Class IIClear Eyes Maximum Redness and Itchy Eye Relief Sidekick Display; each display contains 12 each of aJuly 26, 2019
D-1012-2019Class IILittle Remedies New Baby Essentials Kit. Each kit contains 1 each of the following products: Little March 7, 2019
D-1113-2015Class IISUCRETS Sore Throat & Cough Vapor Cherry lozenges, 18-count tin, Dist. By: Insight Pharmaceuticals, May 21, 2015
D-1077-2015Class IIIMONISTAT 1 SIMPLE CURE (Miconazole Nitrate Vaginal Insert) 1200 mg ovule, 1-DAY MAXIMUM STRENGTH TREApril 10, 2015
D-1673-2012Class IILittle Remedies For Tummys, Stimulant Laxative (sennosides) Drops, 1 FL OZ (30 mL), Dist. by MedtechJune 20, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K242803Compound W Skin Tag RemoverNovember 6, 2024
K202974DenTek Fresh Protect Dental GuardDecember 22, 2020
K180933DenTek Ultimate Dental GuardSeptember 17, 2018
K172373Compound W Nitro-FreezeNovember 2, 2017
K163401Nix Ultra Lice Treatment KitMarch 21, 2017
K161294Compound W Wart Removal System Dual PowerSeptember 15, 2016
K063401BANANA RIBBEDMarch 26, 2007
K012969DOUBLE SPRINGERS NONOXNOL 9 CONDOMJune 12, 2002
K993737MIGHTY MAN (DYNAMIC LINKERS)March 20, 2000
K993735DOUBLE SPRINGERSMarch 20, 2000
K993733LOVE LOCKERSMarch 20, 2000
K853141ACCESS DIGIWIPE SYSTEMNovember 18, 1985
K851034NOVATHERMSeptember 27, 1985
K843601ACCESS HEMAWIPEJanuary 4, 1985