FDA applicant
Powerful Medical, Inc.
FDA records 1 decision for Powerful Medical, Inc. (New York, NY) in 2026: 1 De Novo grant. All are in product code SHS (Unnamed device). 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 Powerful Medical, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2026
2026high 1 (2026)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2026.
Planning a device like Powerful Medical, Inc.’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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