Panels › Obstetrics/Gynecology › Product code HEX · Class 2
Colposcope (And Colpomicroscope)
Regulation 884.1630
0510(k)s in 12 months (56 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in HEX
| Company | 510(k)s | Recalls |
|---|---|---|
| Wallach Surgical Devices, Inc. | 4 | 0 |
| Dynatech Cryomedical Co. | 3 | 0 |
| Lutech Industries, Inc. | 3 | 0 |
| Sti Medical Systems | 3 | 0 |
| CooperSurgical, Inc. | 2 | 0 |
| Hill-Med, Inc. | 2 | 0 |
| Leisegang Medical, Inc. | 2 | 0 |
| Medgyn Products, Inc. | 2 | 0 |
| Welch Allyn, Inc. | 2 | 0 |
| All-Pro Imaging Corp. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 13, 1980 | K801730 | KRYMED SYSTEM 4001 TILT SCOPE Cryomedics, Inc. | HEX |
| Sep 17, 1979 | K791279 | KOLPOSKOP KP20005 Elmed, Inc. | HEX |
| Jun 3, 1977 | K770896 | COLPOSCOPE MODEL II Dynatech Cryomedical Co. | HEX |
| May 20, 1977 | K770697 | COLPOSCOPE SYSTEM Richard Wolf Medical Instruments Corp. | HEX |
| Dec 17, 1976 | K761205 | DYNATECH JD7/JD7P COLPOSCOPE Dynatech Cryomedical Co. | HEX |
| Oct 20, 1976 | K760763 | COLPOSCOPE (DYNATECH COLPOSCOPE-MODEL I Dynatech Cryomedical Co. | HEX |
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