FDA applicant
Hjarta Care, LLC
FDA records 1 decision for Hjarta Care, LLC (Waukesha, WI) in 2026: 1 De Novo grant. All are in product code SHR (Device For Open Surgical Explant Of…). 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 Hjarta Care, LLC’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 Hjarta Care, LLC’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