Panels › Obstetrics/Gynecology › Product code OQY · Class 2
Intrauterine Tamponade Balloon
Regulation 884.4530
1510(k)s in 12 months (11 all time)
0recalls in 12 months (2 all time)
1recalls that name a 510(k)
Top companies in OQY
| Company | 510(k)s | Recalls |
|---|---|---|
| Clinical Innovations, LLC | 2 | 2 |
| Alydia Health | 2 | 0 |
| Cook Incorporated | 2 | 0 |
| Glenveigh Surgical, LLC | 1 | 0 |
| Organon, LLC | 1 | 0 |
| Sinapi Biomedical (Pty) , Ltd. | 1 | 0 |
| Ujenzi Charitable Trust | 1 | 0 |
| Utah Medical Products, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 15, 2026 | K253642 | Jada System (Jada-2002) Organon, LLC | OQY |
| Nov 13, 2023 | K230849 | ELLAVI UBT Sinapi Biomedical (Pty) , Ltd., ZA | OQY |
| Oct 28, 2022 | K223098 | Bakri Essential Postpartum Balloon Cook Incorporated | OQY |
| Sep 30, 2021 | K212757 | Jada System Alydia Health | OQY |
| Aug 28, 2020 | K201199 | Jada System Alydia Health | OQY |
| Oct 30, 2019 | K191264 | Every Second Matters-Uterine Balloon Tamponade (ESM-UBT) Ujenzi Charitable Trust | OQY |
| Mar 31, 2017 | K170622 | Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component Cook Incorporated | OQY |
| Jan 14, 2016 | K153591 | ebb Complete Tamponade System Clinical Innovations, LLC | OQY |
| Mar 25, 2015 | K150573 | ebb Complete Tamponade System Clinical Innovations, LLC | OQY |
| Jan 11, 2011 | K101535 | BT-CATH Utah Medical Products, Inc. | OQY |
| Apr 30, 2010 | K091958 | BELFORT-DILDY OBSTETRIC TAMPONADE SYSTEM Glenveigh Surgical, LLC | OQY |
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