Medtech Products, Inc.
FDA Regulatory Profile
Medtech Products, Inc. appears in FDA public data with 18 recalls, 14 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-1831-2019, Class II) was initiated on July 26, 2019. Its most recent 510(k) clearance was granted on November 6, 2024.
Summary
- Total Recalls
- 18
- 510(k) Clearances
- 14
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
| D-1831-2019 | Class II | Clear Eyes Maximum Redness Relief Club Pack Display; each display contains 18 3-Pack bottles (UPC 6 | July 26, 2019 |
| D-1825-2019 | Class II | Clear eyes MAXIMUM REDNESS RELIEF (Glycerin 0.5%, Naphazoline hydrochloride 0.03%) eye drops, 0.5 FL | July 26, 2019 |
| D-1830-2019 | Class II | Clear Eyes Maximum Itchy Eye Relief Sidekick Floor Stand Display; each display contains 12 each of C | July 26, 2019 |
| D-1822-2019 | Class II | Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops, packaged in | July 26, 2019 |
| D-1824-2019 | Class II | Clear eyes MAXIMUM ITCHY EYE RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%, Zinc Sulfate | July 26, 2019 |
| D-1829-2019 | Class II | Clear Eyes Redness Relief Club Pack Display; each display contains 18 3-Pack bottles (UPC 6 78112 10 | July 26, 2019 |
| D-1833-2019 | Class II | Clear Eyes Redness Relief Handy Pocket Pal Club Pak Display; each display (case UPC 30300742541283) | July 26, 2019 |
| D-1834-2019 | Class II | Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops, Handy Pocket | July 26, 2019 |
| D-1828-2019 | Class II | Clear Eyes Assorted Sidekick Floor Stand Display; each display contains 6 each of a) Clear eyes REDN | July 26, 2019 |
| D-1823-2019 | Class II | Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops, Handy Pocket | July 26, 2019 |
| D-1827-2019 | Class II | Clear Eyes Maximum Redness and Itchy Eye Relief Sidekick Display; each display contains 12 each of a | July 26, 2019 |
| D-1835-2019 | Class II | Clear Eyes Redness Relief Hand Pocket Pal Tray Display; each display (UPC 6 78112 25418 7) contains | July 26, 2019 |
| D-1826-2019 | Class II | Clear Eyes Assorted IRC Display; each display contains 6 each of a) Clear eyes REDNESS RELIEF (Glyce | July 26, 2019 |
| D-1832-2019 | Class II | Clear Eyes Maximum Itchy Eye Relief Sidekick Floor Stand Display; each display (case UPC 10678112736 | July 26, 2019 |
| D-1012-2019 | Class II | Little Remedies New Baby Essentials Kit. Each kit contains 1 each of the following products: Little | March 7, 2019 |
| D-1113-2015 | Class II | SUCRETS Sore Throat & Cough Vapor Cherry lozenges, 18-count tin, Dist. By: Insight Pharmaceuticals, | May 21, 2015 |
| D-1077-2015 | Class III | MONISTAT 1 SIMPLE CURE (Miconazole Nitrate Vaginal Insert) 1200 mg ovule, 1-DAY MAXIMUM STRENGTH TRE | April 10, 2015 |
| D-1673-2012 | Class II | Little Remedies For Tummys, Stimulant Laxative (sennosides) Drops, 1 FL OZ (30 mL), Dist. by Medtech | June 20, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
| K242803 | Compound W Skin Tag Remover | November 6, 2024 |
| K202974 | DenTek Fresh Protect Dental Guard | December 22, 2020 |
| K180933 | DenTek Ultimate Dental Guard | September 17, 2018 |
| K172373 | Compound W Nitro-Freeze | November 2, 2017 |
| K163401 | Nix Ultra Lice Treatment Kit | March 21, 2017 |
| K161294 | Compound W Wart Removal System Dual Power | September 15, 2016 |
| K063401 | BANANA RIBBED | March 26, 2007 |
| K012969 | DOUBLE SPRINGERS NONOXNOL 9 CONDOM | June 12, 2002 |
| K993737 | MIGHTY MAN (DYNAMIC LINKERS) | March 20, 2000 |
| K993735 | DOUBLE SPRINGERS | March 20, 2000 |
| K993733 | LOVE LOCKERS | March 20, 2000 |
| K853141 | ACCESS DIGIWIPE SYSTEM | November 18, 1985 |
| K851034 | NOVATHERM | September 27, 1985 |
| K843601 | ACCESS HEMAWIPE | January 4, 1985 |