EWD
14 FDA 510(k) clearances · Product code
137 daysmedian time to decision
317 days90th percentile
14clearances measured
FDA profile
- Official device name
- Protector, Hearing (Insert)
- Device class
- Unclassified
- Medical specialty
- Unknown
- Adverse events (MAUDE)
- 2000: 1 · 2002: 1 · 2004: 1 · 2008: 2
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 |
|---|---|---|
| ADULT SILICONE EAR PLUGS, MODELS # 68053, 68057 (K020296) | Apothecary Products, Inc. | 2002-06-25 |
| SUPER SILIPLUGS EAR PLUGS (K972923) | Interview Medical Technology Corp. | 1997-10-27 |
| SILICONE PUTTY EAR PLUGS (K971517) | Bentec Medical, Inc. | 1997-06-02 |
| HEARSAVER (K962292) | Emtech Laboratories | 1996-10-29 |
| THE VIRTUAL M-332 (K960500) | Virtual Corp. | 1996-04-03 |
| DOC'S PROPLUGS EAR PLUGS (K945376) | Doc'S Proplugs, Inc. | 1995-11-14 |
| MODEL 322 CLINICAL AUDIOMETER (K930203) | Virtual Corp. | 1993-07-08 |
| #903 SILAFLEX II (K915739) | Flents Products Co., Inc. | 1992-06-30 |
| SEAL-RITE SILICONE EAR PLUG (K910177) | Flents Products Co., Inc. | 1991-06-24 |
| DOC'S PROPLUGS EAR PLUGS (K862045) | Doc'S Proplugs, Inc. | 1987-04-10 |
| MEDCO CUSTOM EAR PROTECTOR MOLD KIT (K821187) | Santa Barbara Medco, Inc. | 1982-05-27 |
| BILSOM PROPP (K791608) | Bilson International, Inc. | 1979-10-10 |
| EAR STOPPLES FOR NOISE ATTENTION (K781907) | Crown Delta Corp. | 1978-11-22 |
| PRO-MOLD, CUSTOM EAR (K781491) | Mcghan Medical Corp. | 1978-09-27 |
Track EWD automatically
Every clearance here is in the API, with alerts when new ones post.