Panels › Obstetrics/Gynecology › Product code HHI · Class 2
System, Abortion, Vacuum
Regulation 884.5070
0510(k)s in 12 months (24 all time)
0recalls in 12 months (2 all time)
1recalls that name a 510(k)
Top companies in HHI
| Company | 510(k)s | Recalls |
|---|---|---|
| Intl. Medical Technologies, Inc. | 4 | 0 |
| Cosmedtech, Inc. | 3 | 0 |
| Williams Specialty Products, Inc. | 2 | 0 |
| Acmi Corporation | 1 | 0 |
| American Hospital Supply Corp. | 1 | 0 |
| Baxter Healthcare Corp | 1 | 0 |
| Berkeley Medevices | 1 | 0 |
| Brooke Intl. | 1 | 0 |
| Cooper Laboratories | 1 | 0 |
| Cooper Medical Devices Corp. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 12, 2019 | Olympus Corporation of the Americas Berkeley Disposa-Filter used with Berkeley VC-10 Vacuum Curettage System - Product Usage: designed for rapid transcervical aspiration of the uterine cavity.
Part# 54298-10/pack Open, Classified |
HHI | K030935 |
| May 19, 2016 | Richard Wolf Medical Instruments Corp. Conical portio adapter (acorn) small & large are used for examination and diagnosis in conjunction with endoscopic accessories in gynecological laparoscopy, to determine patency of the fallopian tubes Terminated |
HHI | None listed |
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