Pentax Medical Of America, Inc.

FDA Regulatory Profile

Pentax Medical Of America, Inc. has 0 FDA recalls, 0 inspections, 2 510(k) clearances and 0 compliance actions on record.

Latest 510(k)
Oct 26, 2018

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances2Oct 4, 2026Not statedCurrent
Inspections0Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent 510(k) Clearances

K-NumberDeviceDate
K180285PENTAX Medical Video Colonoscope EC34-i10T SeriesOct 26, 2018
K180292PENTAX Video Upper G.I. Scope EG34-i10Oct 12, 2018