FDA applicant
Primeline Medical Products, Inc.
FDA records 9 decisions for Primeline Medical Products, Inc. (Edmonton, Alberta, CA) from 1997 to 2002: 9 510(k) clearances. Most are in product codes KKX (Drape, Surgical, Antimicrobial) and FXX (Mask, Surgical). 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 Primeline Medical Products, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Primeline Medical Products, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Primeline Medical Products, 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) ReportOther applicant names beginning “Primeline”
FDA records each applicant name separately; these may or may not be the same firm.