Panels › Obstetrics/Gynecology › Product code HDF · Class 1
Speculum, Vaginal, Metal
Regulation 884.4520
0510(k)s in 12 months (11 all time)
0recalls in 12 months (3 all time)
0recalls that name a 510(k)
Top companies in HDF
| Company | 510(k)s | Recalls |
|---|---|---|
| Conphar, Inc. | 2 | 0 |
| Downs Surgical , Ltd. | 2 | 0 |
| Zinnanti Surgical Instruments, Inc. | 2 | 0 |
| Artiberia | 1 | 0 |
| Carefusion 2200 Inc | 0 | 1 |
| Centurion Medical Products Corporation | 0 | 1 |
| Franklin Medical USA, Inc. | 1 | 0 |
| Gynescope Corp. | 1 | 0 |
| Kinetic Medical Products | 1 | 0 |
| Sklar Instruments | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 16, 2025 | Sklar Instruments ECONO STERILE medical procedure kits labeled as:
1) ECONO STERILE GRAVES SPEC STRL SM BX/25, Model Number 96-2603;
2) ECONO STERILE GRAVES SPEC STRL MD BX/25, Model Number 96-2605;
3) ECONO STER Open, Classified |
HDF | None listed |
| Apr 21, 2023 | Carefusion 2200 Inc (1) Carefusion V. Mueller Graves Vaginal Speculum, Catalog #GL11, Medium Blade, 4 x 1 3/8" (10.2 X 3.5cm); and (2) Carefusion V. Mueller Pederson Vaginal Specula, Catalog #GL31, Medium, 4 x 7/8" (10.2 Open, Classified |
HDF | None listed |
| Jul 1, 2019 | Centurion Medical Products Corporation STERILE GRAVES VAGINAL SPECULUM MEDIUM Kit Code # GVS10MST - Product Usage:The speculum is used to spread the walls of the vagina to facilitate examination. It is used by medical professionals in a cl Terminated |
HDF | None listed |
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