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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 4, 2016 | CooperSurgical, Inc. Milex Arcing Diaphragm Size 95; Model Number: MXWS95 Terminated |
HDW | K063223 |
| Jun 18, 2015 | CooperSurgical, Inc. MILEX OMNIFLEX DIAPHRAGM SIZE 80
Model: MXWF80 Terminated |
HDW | K063223 |
| Mar 28, 2013 | Cooper Surgical, Inc. Omniflex Diaphragm - Size 65 (Milex Wide Seal Silicone Vaginal Diaphragm) Model MXWF65
Intended for use in contraception. Terminated |
HDW | K063223 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.