Panels › Obstetrics/Gynecology › Product code HED · Class 1
Douche Apparatus, Vaginal, Therapeutic
Regulation 884.5900
0510(k)s in 12 months (12 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in HED
| Company | 510(k)s | Recalls |
|---|---|---|
| The Healthcare Group Laboratories, Inc. | 3 | 0 |
| Abbott Research Group, Inc. | 1 | 0 |
| Chatten Drug & Chemical Co. | 1 | 0 |
| Corisen Group, Ltd. | 1 | 0 |
| Geneva Laboratories, Inc. | 1 | 0 |
| Goomi Ehwa, Inc. | 1 | 0 |
| Mac Lee Medical Products | 1 | 0 |
| Orion Life Systems, Inc. | 1 | 0 |
| Pa Medical Corp. | 1 | 0 |
| Snow Willow Co. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 10, 2008 | K080200 | WATER WORKS DOUCHING DEVICE Abbott Research Group, Inc. | HED |
| Apr 22, 2003 | K030056 | WORRY-REMOVER IRRIGATOR Corisen Group, Ltd. | HED |
| Aug 8, 2000 | K000736 | LA JOIE Goomi Ehwa, Inc. | HED |
| Aug 6, 1990 | K902830 | PERI-BOTTLE Orion Life Systems, Inc. | HED |
| Jun 7, 1988 | K881216 | GENT-L-KARE VAGINAL IRRIGATION SET Geneva Laboratories, Inc. | HED |
| Jan 13, 1986 | K854595 | P.A. MEDICAL VAGINAL IRRIGATION SET #1130 Pa Medical Corp. | HED |
| Jun 19, 1984 | K841710 | MAC LEE VAGINAL IRRIGATOR Mac Lee Medical Products | HED |
| Sep 12, 1983 | K831667 | FEMININE HYGIENE DEVICE Snow Willow Co. | HED |
| Oct 3, 1980 | K800956 | DOUCH TRAY-DISPOSABLE VAGINAL TRAY W/BEN The Healthcare Group Laboratories, Inc. | HED |
| Oct 3, 1980 | K800954 | DOUCHE TRAY-DISPOS. VAGINAL TRAY W/POVID The Healthcare Group Laboratories, Inc. | HED |
| Jul 14, 1980 | K800957 | DOUCHE UNIT-1500 ML DISP. CONTAINER The Healthcare Group Laboratories, Inc. | HED |
| Aug 10, 1978 | K781207 | DOUCHE KIT, SOMETHING PERSONAL Chatten Drug & Chemical Co. | HED |
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