FDA applicant
Cohera Medical, Inc.
FDA records 1 decision for Cohera Medical, Inc. (Pittsburgh) in 2015: 1 original PMA approval. All are in product code PJK (Tissue Adhesive For Internal Use). 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 Cohera Medical, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2015
2015high 1 (2015) · low 0 (2016)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2015.
Planning a device like Cohera Medical, Inc.’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