FDA applicant
Kyowa Medex Co., Ltd.
FDA records 1 decision for Kyowa Medex Co., Ltd. (Arlington, VA) in 1990: 1 510(k) clearance. All are in product code FQZ (Thermometer, Clinical Color Change). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Kyowa Medex Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Kyowa Medex Co., Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Kyowa Medex 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