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Hemostatix Medical Technologies, LLC

FDA Regulatory Profile

Hemostatix Medical Technologies, LLC has 0 FDA recalls, 2 inspections, 2 510(k) clearances and 0 compliance actions on record.

Latest inspection
May 2, 2023 · NAI
Latest 510(k)
Nov 26, 2018

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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) clearances2Oct 4, 2026Not statedCurrent
Inspections2Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
May 2, 2023Bartlett, TNDevicesNo Action Indicated (NAI)3006119098
Feb 2, 2018Bartlett, TNDevicesNo Action Indicated (NAI)3006119098

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
K183009HEMOSTATIX MODEL P8400 DISPOSABLE HANDLE, HEMOSTATIX MODEL P8400 DISPOSABLE BLADESNov 26, 2018
K091107MODEL P8400 HEMOSTATIX THERMAL SCALPEL SYSTEMMay 1, 2009

FDA data resources