Panels › Obstetrics/Gynecology › Product code HIO · Class 1
Sampler, Amniotic Fluid (Amniocentesis Tray)
Regulation 884.1550
0510(k)s in 12 months (20 all time)
0recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in HIO
| Company | 510(k)s | Recalls |
|---|---|---|
| E-Z-Em, Inc. | 3 | 0 |
| Universal Medical Instrument Corp. | 2 | 0 |
| Aptek , Ltd. | 1 | 0 |
| Baxter Healthcare Corp | 1 | 0 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 1 | 0 |
| Cameo, Inc. | 1 | 0 |
| Concord/Portex | 1 | 0 |
| Contour Fabricators of Florida, Inc. | 1 | 0 |
| Cook Ob/Gyn | 1 | 0 |
| Critical Specialties, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare HENRY SCHEIN, Amnio Tray, Item No.570-3059, Open, Classified |
HIO | None listed |
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