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Fulwell, LLC

FDA Regulatory Profile

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

Latest inspection
Mar 3, 2022 · NAI
Latest 510(k)
Nov 24, 2020

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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
Mar 3, 2022Miami, FLDevicesNo Action Indicated (NAI)3010131466
Apr 23, 2015Miami, FLDevicesNo Action Indicated (NAI)3010131466

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
K200931RF Surgical GeneratorNov 24, 2020
K183564Electrosurgical GeneratorJun 13, 2019

FDA data resources