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Polarisar, Inc.

FDA Regulatory Profile

Polarisar, Inc. appears in FDA public data with 0 recalls, 1 510(k) clearance, 1 FDA inspection, and 0 compliance actions on record. Its most recent FDA inspection ended on Feb 14, 2025 (Voluntary Action Indicated (VAI)). Its most recent 510(k) clearance was granted on Nov 2, 2023.

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Summary

Total Recalls
0
510(k) Clearances
1
Inspections
1
Compliance Actions
0

Recent FDA Inspections

DateSiteProductClassificationFEI
Feb 14, 2025Richardson, TXDevicesVoluntary Action Indicated (VAI)3025287527

FDA Data Dashboard classifications: NAI (no action indicated), VAI (voluntary action indicated), OAI (official action indicated).

Recent 510(k) Clearances

K-NumberDeviceDate
K232176STELLAR KneeNov 2, 2023

FDA data resources