Surgical Direct, Inc.

FDA Regulatory Profile

Surgical Direct, Inc. has 0 FDA recalls, 2 inspections, 1 510(k) clearance and 0 compliance actions on record.

Latest inspection
Mar 24, 2026 · VAI
Latest 510(k)
Dec 20, 2019

Updated: recalls Oct 23, 2026 · inspections Oct 23, 2026 · compliance actions Oct 23, 2026.

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Summary

Recalls
0
510(k) Clearances
1
Inspections
2
Compliance Actions
0

Recent FDA Inspections

DateSiteProductClassificationFEI
Mar 24, 2026Orange City, FLDevicesVoluntary Action Indicated (VAI)3003687489
Aug 3, 2018Orange City, FLDevicesVoluntary Action Indicated (VAI)3003687489

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
K193018Surgical Direct Hand-held Laparoscopic InstrumentsDec 20, 2019