Panels › Obstetrics/Gynecology › Product code HHM · Class 1
Sound, Uterine
Regulation 884.4530
0510(k)s in 12 months (10 all time)
0recalls in 12 months (4 all time)
0recalls that name a 510(k)
Top companies in HHM
| Company | 510(k)s | Recalls |
|---|---|---|
| A & A Medical, Inc. | 2 | 0 |
| CooperSurgical, Inc. | 0 | 2 |
| Axcan Scientific Corp. | 1 | 0 |
| C.R. Bard, Inc. | 1 | 0 |
| Centurion Medical Products Corporation | 0 | 1 |
| Cervilenz, Inc. | 1 | 0 |
| Cook Ob/Gyn | 1 | 0 |
| G.D. Searle and Co. | 1 | 0 |
| Gynemetrics, Inc. | 1 | 0 |
| Hologic, Inc | 0 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 10, 2001 | K011840 | CERVILENZ UTERINE MEASURING SOUND Cervilenz, Inc. | HHM |
| Feb 24, 1994 | K935665 | INTRAUTERINE SOUND Rocket of London, Ltd., GB | HHM |
| Dec 20, 1988 | K884684 | ROCKET INTRAUTERINE DEPTH SOUND A & A Medical, Inc. | HHM |
| Oct 31, 1988 | K883806 | ROCKET INTRAUTERINE SOUND A & A Medical, Inc. | HHM |
| Mar 4, 1987 | K870550 | TEFLON UTERINE SOUND Cook Ob/Gyn | HHM |
| Apr 30, 1984 | K840380 | UTERINE SOUND Intl. Medical Technologies, Inc. | HHM |
| Oct 28, 1983 | K831224 | AUGROS HYSTEROMETER Axcan Scientific Corp. | HHM |
| Jan 12, 1981 | K802315 | UTERINE SOUND Gynemetrics, Inc. | HHM |
| Dec 7, 1978 | K781766 | UTERINE SOUND, BURNETT DISPOSABLE C.R. Bard, Inc. | HHM |
| Jul 19, 1976 | K760170 | INTRAUTERINE SOUND, PLASTIC DISPOSABLE G.D. Searle and Co. | HHM |
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