Panels › Obstetrics/Gynecology › Product code PEB · Class 2
Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible
Regulation 884.5300
0510(k)s in 12 months (10 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in PEB
| Company | 510(k)s | Recalls |
|---|---|---|
| CC Wellness, LLC | 2 | 0 |
| Biofilm, Inc. | 1 | 0 |
| Church & Dwight Co., Inc. | 1 | 0 |
| Fairhaven Health, LLC | 1 | 0 |
| Good Clean Love, Inc. | 1 | 0 |
| Ingfertility, LLC | 1 | 0 |
| Ingfertlity, LLC | 1 | 0 |
| Sasmar, Inc. | 1 | 0 |
| United Consortium | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 11, 2022 | K212885 | Actively Trying Personal Lubricant Rose Scented CC Wellness, LLC | PEB |
| Feb 9, 2022 | K212705 | Actively Trying Personal Lubricant Unfragrance CC Wellness, LLC | PEB |
| Jul 23, 2020 | K193450 | Pre-Seed Fertility Lubricant Church & Dwight Co., Inc. | PEB |
| Nov 7, 2019 | K190872 | BioGenesis Fertility Lubricant Good Clean Love, Inc. | PEB |
| Apr 26, 2019 | K182585 | JO Actively Trying Personal Lubricant United Consortium | PEB |
| Apr 28, 2017 | K162319 | BabyDance Fertility Lubricant Fairhaven Health, LLC | PEB |
| Jan 9, 2015 | K141132 | ASTROGLIDE TTC FERTILITY FRIENDLY PERSONAL LUBRICANT Biofilm, Inc. | PEB |
| Nov 7, 2013 | K131355 | CONCEIVE PLUS Sasmar, Inc. | PEB |
| Jul 16, 2008 | K072741 | PRE-VA VAGINAL LUBRICANT Ingfertility, LLC | PEB |
| Oct 13, 2006 | K051436 | PRE' VAGINAL LUBRICANT Ingfertlity, LLC | PEB |
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