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
| Records | Count | Last refreshed | Source as of | Status |
| Recalls | 0 | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 8 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 1 | Nov 9, 2026 | Newest record Oct 28, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
| Dec 15, 2016 | Kawaguchi, Japan | Devices | Voluntary 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
| Facility | Location | Inspections | Latest |
| FEI 3008918179 | Kawaguchi, Japan | 1 | Dec 15, 2016 |
Recent 510(k) Clearances
| K-Number | Device | Date |
| K242212 | Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit) | Aug 27, 2024 |
| K173450 | PRESS DUO elite, PRESS DUO elite AG | Feb 7, 2018 |
| K133189 | DUAL SHOT ALPHA 7 | Jun 30, 2014 |
| K092896 | REMPRESS AND ANGIOGRAPHY CONTRAST DELIVERY SYSTEM REMPRESS | Oct 29, 2010 |
| K091734 | SONIC SHOT GX | May 21, 2010 |
| K071691 | DUAL SHOT ALPHA | Dec 19, 2007 |
| K062168 | CONTRAST DELIVERY SYSTEM - DUAL SHOT ALPHA | Aug 18, 2006 |
| K052633 | DUAL SHOT - CONTRAST DELIVERY SYSTEM | Oct 17, 2005 |