FDA applicant
Jms Co., Ltd.
FDA records 25 decisions for Jms Co., Ltd. (Hiroshima, JP) from 1985 to 2004: 25 510(k) clearances. Most are in product codes FIE (Needle, Fistula) and FMI (Needle, Hypodermic, Single Lumen). No recall is linked to its devices.
FDA’s records also spell it “Jms, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Jms Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Jms Co., Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Jms Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report