Home › Device types › OQY
Intrauterine Tamponade Balloon
FDA product code OQY · Class 2 · Obstetrics/Gynecology
10
Registered devices
1,328
Adverse events
2
Recalls
11
510(k) clearances
Devices with this code
Jada™ System — Alydia Health, Inc.Bakri — COOK INCORPORATEDBakri — COOK INCORPORATEDBakri® — Coopersurgical, Inc.BT-CATH — UTAH MEDICAL PRODUCTS, INC.Ebb® Complete Tamponade System — CLINICAL INNOVATIONS, LLCBT-CATH — UTAH MEDICAL PRODUCTS, INC.Bakri® — Coopersurgical, Inc.JADA System — Organon LLCBakri — COOK INCORPORATED
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2015-01-05 | Clinical Innovations, LLC | Clinical Innovations, LLC is voluntarily recalling the Ebb Complete Tamponade System (CTS-1000) Lot Number 1214-F-403.) to address the potential for a balloon l |
| 2014-12-30 | Clinical Innovations, LLC | Potential for a balloon leak in all lots of (CTS-1000) manufactured since August 2014. |
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