FDA applicant
Intramed Laboratories, Inc.
FDA records 14 decisions for Intramed Laboratories, Inc. (San Diego, CA) from 1987 to 1996: 14 510(k) clearances. Most are in product codes LYK (Angioscope) and MGZ (Valvulotome). 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 Intramed Laboratories, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Intramed Laboratories, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Intramed Laboratories, 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 “Intramed”
FDA records each applicant name separately; these may or may not be the same firm.