HDW
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Diaphragm, Contraceptive (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.5350
- Medical specialty
- Obstetrics/Gynecology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1998: 1 · 2000: 1 · 2001: 1 · 2004: 2 · 2010: 6 · 2013: 13
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| CAYA CONTOURED DIAPHRAGM (K140305) | Kessel Medintim GmbH | 2014-08-26 |
| ORTHO ALL-FLEX DIAPHRAGM (K080040) | Johnson & Johnson Produtos Profissionais Ltda. | 2008-08-25 |
| MILEX CONTRACEPTIVE DIAPHRAGM, OMNIFLEX DIAPHRAGMS, ARCING DIAPHRAGMS, WIDESEAL DIAPHRAGMS (K063223) | CooperSurgical, Inc. | 2008-01-23 |
| ONCE TM (K800162) | G.D. Searle and Co. | 1980-02-11 |
Track HDW automatically
Every clearance here is in the API, with alerts when new ones post.