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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 24, 1994 | K930034 | CERVICAL DILATORS:PRATT,HAWKIN,KLEEGMAN,DENNISTON Thomasville Medical Assoc. | HDQ |
| Sep 13, 1990 | K896701 | TEFLON CERVICAL ACCESS SET Cook Ob/Gyn | HDQ |
| Mar 17, 1989 | K891029 | CERVICAL DILATORS PRATT,HAWKIN,KLEEGMAN,DENN.,VALL Zinnanti Surgical Instruments, Inc. | HDQ |
| Feb 13, 1989 | K890377 | FIXED-SIZE UTERINE DILATOR Kinetic Medical Products | HDQ |
| Jul 16, 1981 | K811568 | CERVICAL DILATOR Gynemetrics, Inc. | HDQ |
| Aug 22, 1979 | K791277 | MODEL 6500 EXTRACTION IRRIGATION SYS Cavitron Corp. | HDQ |
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