silverlon-clinical-evaluation

Indications for Use

 View Indications for Use Statements

In Vitro Studies

Please note that these studies may involve findings that exceed the claims currently cleared by the FDA for the product. Argentum Medical, LLC is not intending to make performance claims about its product. The intent is to disseminate the scientific literature on these products. We encourage you to read these studies to understand the strengths and limitations of the data.  For some claims, Argentum is seeking to broaden the indications with the FDA in the future using data, such as these studies, to provide the substantiation.

ISO Certificates

ISO 13485:2003

FDA Marketing Clearances

510(k) K143001
Silverlon® Island Dressing
Silverlon® Wound Pad Dressing

510(k) K141033
Silverlon® Antimicrobial Wound Contact Negative Pressure Dressing
Silverlon® EasyAg™ Antimicrobial Wound Contact Negative Pressure Dressing 

510(k) K141573
Silverlon® Island Wound Dressing Flexible

510(k) K122817
Silverlon® Island Wound Dressing

510(k) K984204
Silverlon® Direct Pressure Wound Closure

510(k) K984205
Silverlon® Adhesive Strip

510(k) K053590
Silverlon® CA Antimicrobial Calcium Alginate Dressing

510(k) K023612
Silverlon® Wound Contact Dressing
Silverlon® Burn Contact Dressing
Silverlon® Burn Wrap Dressing
Silverlon® Acute Burn Glove

510(k) K023609
Silverlon® Adhesive Strip

510(k) K984210
Silverlon® Wound Packing Strips

510(k) K984208
Silverlon® Island Dressing
Silverlon® Island Pad Dressing

510(k) K981299
Silverlon® Contact Wound Dressing (1- and 4-layer)