DeviceClearance

Pentax of America, Inc.

Pentax of America, Inc. holds 44 FDA 510(k) medical device clearances, first cleared 2012, most recent 2025, with 33 FDA device recalls on record.

Top product codes for Pentax of America, Inc.

FDA recalls by Pentax of America, Inc.

10 most recent of 33

Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.

Recent clearances by Pentax of America, Inc.

Data sourced from openFDA. This site is unofficial and independent of the FDA.