SEJ
6 FDA 510(k) clearances · Product code
194 daysmedian time to decision
366 days90th percentile
6clearances measured
FDA profile
- Official device name
- Wound Dressings Containing Topical Analgesics
- Device class
- Unclassified
- Medical specialty
- Unknown
- FDA definition
- A solid wound dressing containing topical analgesics is used to cover and protect a wound, to absorb exudate, to maintain appropriate moisture balance within the wound, and to reduce pain. A wound dressing formulated as a gel, cream or ointment containing topical analgesics is used to maintain appropriate moisture balance within the wound and to reduce pain.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| AMERIGEL WOUND DRESSING PLUS 1/2 OZ. (15G TUBE), MODEL A2025; 1 OZ. (30G TUBE), MODEL A2026; 3 OZ (90G TUBE),MODEL A2027 (K092086) | Amerx Health Care Corp. | 2009-07-30 |
| ALLWOUND (K053476) | At Squared, LLC | 2006-06-26 |
| REGENECARE WOUND GEL (K020540) | Mpm Medical., Inc. | 2002-11-01 |
| FREEDOM, MODEL 4660 (K001023) | Johnson & Johnson Consumer Companies, Inc. | 2000-09-22 |
| HEMO-STAT (K922636) | Mckinley-Ross Laboratories, Inc. | 1992-11-09 |
| MICRO-COLL COLLAGEN WOUND SPRAY (K912565) | Micro-Coll | 1992-06-11 |
Track SEJ automatically
Every clearance here is in the API, with alerts when new ones post.