Home › PENTAX OF AMERICA, INC. › N/A
N/A
PENTAX OF AMERICA, INC. · Model KBM86531P · UDI-DI 04961333243259
PEA
Prescription
1
510(k) clearances
609
Adverse events
4
Recalls
12
Facilities
Description
EPK-I LAMP KIT (BIOMED REPLACEMENT)
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 dark. Users have observ |
| 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 dark (1.8%). Users |
| 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 dark (1.8%). Users |
| 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 dark (1.8%). Users |
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 docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.