Linatech, LLC

FDA Regulatory Profile

Linatech, LLC appears in FDA public data with 0 recalls, 4 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent FDA inspection ended on Sep 29, 2021 (Voluntary Action Indicated (VAI)). Its most recent 510(k) clearance was granted on Apr 12, 2024.

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Summary

Total Recalls
0
510(k) Clearances
4
Inspections
2
Compliance Actions
0

Recent FDA Inspections

DateSiteProductClassificationFEI
Sep 29, 2021Sunnyvale, CADevicesVoluntary Action Indicated (VAI)3007037519
Nov 8, 2019Sunnyvale, CADevicesVoluntary Action Indicated (VAI)3007037519

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

Recent 510(k) Clearances

K-NumberDeviceDate
K232489VenusXApr 12, 2024
K092550TIGRT IVSDec 15, 2009
K090893TIGRT TPSJul 15, 2009
K090802TIGRT MLC, TIGRT DMLCJul 7, 2009