Panels › Obstetrics/Gynecology › Product code HDW · Class 2
Diaphragm, Contraceptive (And Accessories)
Regulation 884.5350
0510(k)s in 12 months (4 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in HDW
| Company | 510(k)s | Recalls |
|---|---|---|
| CooperSurgical, Inc. | 1 | 2 |
| Cooper Surgical, Inc. | 0 | 1 |
| G.D. Searle and Co. | 1 | 0 |
| Johnson & Johnson Produtos Profissionais Ltda. | 1 | 0 |
| Kessel Medintim GmbH | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 26, 2014 | K140305 | CAYA CONTOURED DIAPHRAGM Kessel Medintim GmbH, DE | HDW |
| Aug 25, 2008 | K080040 | ORTHO ALL-FLEX DIAPHRAGM Johnson & Johnson Produtos Profissionais Ltda. | HDW |
| Jan 23, 2008 | K063223 | MILEX CONTRACEPTIVE DIAPHRAGM, OMNIFLEX DIAPHRAGMS, ARCING DIAPHRAGMS, WIDESEAL DIAPHRAGMS CooperSurgical, Inc. | HDW |
| Feb 11, 1980 | K800162 | ONCE TM G.D. Searle and Co. | HDW |
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