Panels › Obstetrics/Gynecology › Product code HDX · Class 2
Dilator, Vaginal
Regulation 884.3900
0510(k)s in 12 months (9 all time)
0recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in HDX
| Company | 510(k)s | Recalls |
|---|---|---|
| Lujena, Inc. | 2 | 0 |
| Materna Medical | 2 | 0 |
| Plus EV Holdings Dba Intimate Rose | 2 | 0 |
| Bioteque America, Inc. | 1 | 0 |
| CooperSurgical, Inc. | 0 | 1 |
| KARL STORZ Endoscopy-America, Inc. | 1 | 0 |
| Panpac Medical Corporation | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 14, 2024 | K241748 | Intimate Rose Vaginal Dilators Plus EV Holdings Dba Intimate Rose | HDX |
| May 2, 2024 | K233689 | Hope&Her Vaginal Dilators Lujena, Inc. | HDX |
| Jun 27, 2023 | K222492 | Hope&Her Vaginal Dilators Lujena, Inc. | HDX |
| Jun 7, 2023 | K231430 | Intimate Rose Vaginal Dilators Plus EV Holdings Dba Intimate Rose | HDX |
| Feb 27, 2023 | K220035 | Milli Vaginal Dilator Materna Medical | HDX |
| Dec 1, 2021 | K211959 | Milli Vaginal Dilator Materna Medical | HDX |
| Aug 8, 2013 | K130273 | PANPAC VAGINAL DILATORS Panpac Medical Corporation, TW | HDX |
| Jan 7, 2009 | K071754 | NEO-VAGINA SURGERY SET AND ACCESSORIES KARL STORZ Endoscopy-America, Inc. | HDX |
| Jan 29, 2001 | K003380 | BIOTEQUE VAGINAL DILATOR Bioteque America, Inc. | HDX |
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