Ast Products, Inc.

FDA Regulatory Profile

Ast Products, Inc. has 0 FDA recalls, 1 inspection, 4 510(k) clearances and 0 compliance actions on record.

Latest inspection
Mar 2, 2017 · NAI
Latest 510(k)
Jun 4, 2020

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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) clearances4Oct 4, 2026Not statedCurrent
Inspections1Oct 23, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Mar 2, 2017Billerica, MADevicesNo Action Indicated (NAI)1000635309

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

Recent 510(k) Clearances

K-NumberDeviceDate
K200057bioli lOL Delivery SystemJun 4, 2020
K182965BL-Cart IOL Delivery CartridgeMar 29, 2019
K172228pioli IOL Delivery SystemDec 15, 2017
K142056LIOLI IOL DELIVERY SYSTEMApr 9, 2015