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Top Corp.

FDA Regulatory Profile

Top Corp. has 0 FDA recalls, 2 inspections, 4 510(k) clearances and 0 compliance actions on record.

Latest inspection
May 29, 2018 · NAI
Latest 510(k)
Sep 3, 2019

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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) clearances4Oct 4, 2026Not statedCurrent
Inspections2Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
May 29, 2018Adachi, JapanDevicesNo Action Indicated (NAI)3002808374
Jul 28, 2015Adachi, JapanDevicesVoluntary Action Indicated (VAI)3002808374

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
K1827655cc Neuraxial Slip Tip Glass Syringe,5cc Neuraxial Lock Tip Glass Syringe,5cc Neuraxial Additive…Sep 3, 2019
K080771TOP NEUROPOLE NEEDLE, MODEL SH, BL, SC, TCNov 10, 2008
K062946TOP NEUROPOLE NEEDLES, MODELS ST, X, RC, XE AND TLFeb 15, 2007
K860449MODIFICATION TOP ULTRA THINWALL A-V FISTULA NEEDLEFeb 26, 1986

FDA data resources