Home › Device types › PEA
Endoscope, Accessories, Image Post-Processing For Color Enhancement
FDA product code PEA · Class 2 · Gastroenterology, Urology
107
Registered devices
609
Adverse events
5
Recalls
9
510(k) clearances
Devices with this code
DEFINA — HOYA CORPORATIONPENTAX — HOYA CORPORATIONPENTAX — HOYA CORPORATIONPENTAX — HOYA CORPORATIONPENTAX Medical — HOYA CORPORATIONOPTIVISTA — HOYA CORPORATIONN/A — PENTAX OF AMERICA, INC.PENTAX Medical — HOYA CORPORATIONFUJIFILM — FUJIFILM CORPORATIONPENTAX Medical — HOYA CORPORATIONN/A — PENTAX OF AMERICA, INC.VIVIDEO — PENTAX OF AMERICA, INC.DEFINA — HOYA CORPORATIONN/A — PENTAX OF AMERICA, INC.N/A — PENTAX OF AMERICA, INC.PENTAX Medical — HOYA CORPORATIONPENTAX — HOYA CORPORATIONN/A — PENTAX OF AMERICA, INC.N/A — PENTAX OF AMERICA, INC.N/A — PENTAX OF AMERICA, INC.PENTAX — HOYA CORPORATIONPENTAX Medical — HOYA CORPORATIONIMAGINA — HOYA CORPORATIONN/A — PENTAX OF AMERICA, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-09-09 | Pentax of America Inc | Warnings added to the IFU for ultrasound endoscopes and water bottle assembly to ensure there is deaerated sterile water in the assembly prior to and during the |
| 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 |
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