FDA applicant
Advantage Medical Systems, Inc.
FDA records 17 decisions for Advantage Medical Systems, Inc. (Mchenry, IL) from 1980 to 1987: 17 510(k) clearances. Most are in product codes HGM (System, Monitoring, Perinatal) and DRT (Monitor, Cardiac (Incl. Cardiotachometer &…). 2 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Advantage Medical Systems, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Advantage Medical Systems, Inc. since 2007.
Recalls per year
1in 2017
Class I Class II/III not classified
Planning a device like Advantage Medical Systems, 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 “Advantage”
FDA records each applicant name separately; these may or may not be the same firm.