Ewing, NJ, US · 6 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| HIS | Condom | Class II | Obstetrics/Gynecology | 3 | 2025-02-21 |
| MOL | Condom, Synthetic | Class II | Obstetrics/Gynecology | 1 | 2024-10-08 |
| NUC | Lubricant, Personal | Class II | Obstetrics/Gynecology | 1 | 2021-06-11 |
| PEB | — | — | — | 1 | 2020-07-23 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2023-01-25 | Class II | Ongoing | Z-1350-2023 | Easy Read App associated with First Response Pregnancy Test Sticks - Intended use of converting analog pregnancy test r… | — | Church & Dwight First Response Pregnancy Kits was marketed with the Easy Read App without a new 510k. There is also a potential for Easy Read App to be unable … |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-02-21 | K243640 | Trojan Ultra Ribbed Ecstasy latex condom with lubricant (Trojan Ultra Ribbed Ecstasy) | HIS | Class II | Obstetrics/Gynecology |
| 2024-10-08 | K240379 | TROJAN SIS Synthetic Latex Condom with Silicone Lubricant | MOL | Class II | Obstetrics/Gynecology |
| 2022-09-28 | K221906 | TROJAN Fire & Ice lubricated male natural rubber latex condom | HIS | Class II | Obstetrics/Gynecology |
| 2022-07-14 | K221431 | TROJAN(TM) Her Pleasure Warming male natural rubber latex condom with warming lubricant | HIS | Class II | Obstetrics/Gynecology |
| 2021-06-11 | K203818 | Replens Long-Lasting Vaginal Moisturizer | NUC | Class II | Obstetrics/Gynecology |
| 2020-07-23 | K193450 | Pre-Seed Fertility Lubricant | PEB | — | — |