Medical Device Manufacturer · US , Elwyn , PA

Elwyn, Inc. - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 1989

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Elwyn, Inc. General & Plastic Surgery ✕

2 devices

1-2 of 2

Cleared May 24, 1989

VARIOUSLY SIZED STERILE COTTON WOUND DRESSINGS

General & Plastic Surgery · 82d

Cleared May 11, 1989

FIRST AID SURVIVAL KIT

General & Plastic Surgery · 55d

Data Source

Sourced from the FDA 510(k) public files . 175,450 total devices indexed.

Last updated: Apr 28, 2026