Panels › Obstetrics/Gynecology › Product code HDQ · Class 1
Dilator, Cervical, Fixed Size
Regulation 884.4530
0510(k)s in 12 months (6 all time)
0recalls in 12 months (4 all time)
1recalls that name a 510(k)
Top companies in HDQ
| Company | 510(k)s | Recalls |
|---|---|---|
| Marina Medical Instruments Inc. | 0 | 2 |
| Cavitron Corp. | 1 | 0 |
| Cook Ob/Gyn | 1 | 0 |
| Gynemetrics, Inc. | 1 | 0 |
| Kinetic Medical Products | 1 | 0 |
| MEDLINE INDUSTRIES, LP - Northfield | 0 | 1 |
| Sklar Instruments | 0 | 1 |
| Thomasville Medical Assoc. | 1 | 0 |
| Zinnanti Surgical Instruments, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 16, 2025 | Sklar Instruments ECONO STERILE medical procedure kits labeled as:
1) ECONO STERILE HEGAR DILATOR 11&12MM STRLCS25Model Number 96-0960;
2) ECONO STERILE HEGAR DILATOR 9&10MM STRL CS25Model Number 96-0961;
3) ECONO Open, Classified |
HDQ | K772229 |
| Mar 29, 2024 | MEDLINE INDUSTRIES, LP - Northfield Centurion Manual surgical kits labeled as:
a) HEGAR UTERINE DILATOR, 11-12MM, STERILE, Product Code HUD112ST;
b) STERILE UTERINE DILATOR 1MM/2MM, Product Code HUD12ST;
c) HEGAR UTERINE DILATOR, 5- Open, Classified |
HDQ | None listed |
| Mar 25, 2010 | Marina Medical Instruments Inc. VNVD Veronikis Neo Vaginal Dilator - Complete Set Catalog No. 270-100,
VNVD Veronikis Neo Vaginal Dilator - 1.5cm Tip:Width:0.625in Catalog No. 270-115 (sold individually),
VNVD Veronikis Neo Vaginal Terminated |
HDQ | None listed |
| Mar 25, 2010 | Marina Medical Instruments Inc. VVD Veronikis Vaginal Dilator - Complete Set Catalog No. 270-000. Set Includes:
VVD Veronikis Vaginal Dilator - 3cm Tip: Width: 1.00in Catalog No. 270-003 (sold individually)
VVD Veronikis Vaginal D Terminated |
HDQ | None listed |
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