FDA applicant
Medical Components, Inc.
FDA records 64 decisions for Medical Components, Inc. (Harleysville, PA) from 1980 to 2026: 64 510(k) clearances. Most are in product codes LJS (Catheter, Intravascular, Therapeutic…) and MSD (Catheter, Hemodialysis, Implanted). Its devices cite 39 predicates, 10 of them its own earlier devices. 24 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Medical Components, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
1in 2020
Class I Class II/III not classified
Planning a device like Medical Components, 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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