510(k) Report

FDA applicant

Advantage Medical Systems, Inc.

Mchenry, IL17 decisions1980–19872 recalls

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, last Nov 3, 2026

FIG. A — Illustration, obstetrics and gynecology panel, where it files most

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

2012: 12017: 1
2007high 1 (2012) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Advantage Medical Systems, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Advantage”

FDA records each applicant name separately; these may or may not be the same firm.