Panels › Obstetrics/Gynecology › Product code PBH · Class 2
Embryo Image Assessment System, Assisted Reproduction
Regulation 884.6195
1510(k)s in 12 months (5 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in PBH
| Company | 510(k)s | Recalls |
|---|---|---|
| Auxogyn, Inc. | 2 | 0 |
| Alife Health | 1 | 0 |
| Fairtility , Ltd. | 1 | 0 |
| Vitrolife A/S | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 15, 2026 | K250781 | Embryo Predict Alife Health | PBH |
| Aug 15, 2025 | K243851 | CHLOE BLAST Fairtility , Ltd., IL | PBH |
| Jul 19, 2019 | K182798 | KIDScore D3 Vitrolife A/S, DK | PBH |
| Nov 24, 2014 | K142147 | EEVA SYSTEM Auxogyn, Inc. | PBH |
| Jun 6, 2014 | DEN120015 | EEVA 2.0 Auxogyn, Inc. | PBH |
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