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Radmedix, LLC

FDA Regulatory Profile

Radmedix, LLC appears in FDA public data with 0 recalls, 6 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent FDA inspection ended on Nov 16, 2023 (No Action Indicated (NAI)). Its most recent 510(k) clearance was granted on Oct 25, 2023.

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Summary

Total Recalls
0
510(k) Clearances
6
Inspections
2
Compliance Actions
0

Recent FDA Inspections

DateSiteProductClassificationFEI
Nov 16, 2023Moraine, OHDevicesNo Action Indicated (NAI)3009134655
Apr 16, 2019Moraine, OHDevicesNo Action Indicated (NAI)3009134655

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

Recent 510(k) Clearances

K-NumberDeviceDate
K231995AcuityUDROct 25, 2023
K231709AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4Jul 12, 2023
K210919AcuityDReApr 30, 2021
K201058Accuvue+May 6, 2020
K200726AcuityPDRApr 13, 2020
K193360Acuity SDR Standard, Acuity SDR Plus, Acuity FDR StandardJan 2, 2020

FDA data resources