Home › Device types › PEA
Endoscope, Accessories, Image Post-Processing For Color Enhancement
FDA product code PEA · Class 2 · Gastroenterology, Urology
107
Registered devices
608
Adverse events
4
Recalls
9
510(k) clearances
Devices with this code
DEFINA — PENTAX OF AMERICA, INC.OPTIVISTA — HOYA CORPORATIONN/A — PENTAX OF AMERICA, INC.N/A — PENTAX OF AMERICA, INC.PENTAX — HOYA CORPORATIONPENTAX — HOYA CORPORATIONVIDEO PROCESSOR — PENTAX OF AMERICA, INC.PENTAX — HOYA CORPORATIONFUJIFILM — FUJIFILM CORPORATIONN/A — PENTAX OF AMERICA, INC.PENTAX Medical — HOYA CORPORATIONFUJIFILM — FUJIFILM CORPORATIONN/A — PENTAX OF AMERICA, INC.PENTAX — HOYA CORPORATIONPENTAX Medical — HOYA CORPORATIONVIDEO PROCESSOR — PENTAX OF AMERICA, INC.PENTAX — HOYA CORPORATIONPENTAX — HOYA CORPORATIONN/A — PENTAX OF AMERICA, INC.PENTAX Medical — HOYA CORPORATIONPENTAX — HOYA CORPORATIONIMAGINA — HOYA CORPORATIONN/A — PENTAX OF AMERICA, INC.N/A — PENTAX OF AMERICA, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-07-16 | Pentax of America Inc | During endoscopic procedures using a combination of the video processor EPK-i8020c and i20c series video endoscope, the observed image can become reddish or dar |
| 2025-01-29 | Pentax of America Inc | During endoscopic procedures using a combination of the video processor EPK-i8020c and the i20c series video endoscope, the observed image can become reddish or |
| 2025-01-29 | Pentax of America Inc | During endoscopic procedures using a combination of the video processor EPK-i8020c and the i20c series video endoscope, the observed image can become reddish or |
| 2025-01-29 | Pentax of America Inc | During endoscopic procedures using a combination of the video processor EPK-i8020c and the i20c series video endoscope, the observed image can become reddish or |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.