FDA applicant
Hemispheres Marketing Co., Ltd.
FDA records 1 decision for Hemispheres Marketing Co., Ltd. (Miami, FL) in 1993: 1 510(k) clearance. All are in product code KCZ (Prosthesis, Breast, External, Used With Adhesive). 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 Hemispheres Marketing Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Hemispheres Marketing Co., Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Hemispheres Marketing Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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