Nemoto Kyorindo Co., Ltd.

FDA Regulatory Profile

Nemoto Kyorindo Co., Ltd. has 0 FDA recalls, 1 inspection, 8 510(k) clearances and 0 compliance actions on record.

Latest inspection
Dec 15, 2016 · VAI
Latest 510(k)
Aug 27, 2024

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 4, 2026 (checked Nov 8, 2026, unchanged)File dated Nov 3, 2026Current
510(k) clearances8Nov 8, 2026File dated Nov 2, 2026Current
Inspections1Nov 9, 2026Newest record Oct 28, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Dec 15, 2016Kawaguchi, JapanDevicesVoluntary Action Indicated (VAI)3008918179

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.

FDA-Inspected Facilities

FacilityLocationInspectionsLatest
FEI 3008918179Kawaguchi, Japan1Dec 15, 2016

Recent 510(k) Clearances

K-NumberDeviceDate
K242212Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit)Aug 27, 2024
K173450PRESS DUO elite, PRESS DUO elite AGFeb 7, 2018
K133189DUAL SHOT ALPHA 7Jun 30, 2014
K092896REMPRESS AND ANGIOGRAPHY CONTRAST DELIVERY SYSTEM REMPRESSOct 29, 2010
K091734SONIC SHOT GXMay 21, 2010
K071691DUAL SHOT ALPHADec 19, 2007
K062168CONTRAST DELIVERY SYSTEM - DUAL SHOT ALPHAAug 18, 2006
K052633DUAL SHOT - CONTRAST DELIVERY SYSTEMOct 17, 2005

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.