FDA applicant
Advamedica, Inc.
FDA records 5 decisions for Advamedica, Inc. (Cambridge, MA) from 2018 to 2023: 5 510(k) clearances. Most are in product codes QSY (Hemostatic Wound Dressing Without Thrombin Or…) and KGN (Wound Dressing With Animal-Derived Material (S)). Since 2016 its 510(k)s took a median of 206 days from receipt to decision, against 194 for FDA’s reviews in the same codes and years. Its devices cite 7 predicates, 0 of them its own earlier devices. 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 Advamedica, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
3in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2018.
Planning a device like Advamedica, 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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