510(k) Report

FDA applicant

Advanced Medical Devices, Inc.

Milwaukee, WI2 decisions1996–19980 recalls

FDA records 2 decisions for Advanced Medical Devices, Inc. (Milwaukee, WI) from 1996 to 1998: 2 510(k) clearances. Most are in product codes CGA (Glucose Oxidase, Glucose) and ELC (Scaler, Ultrasonic). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, clinical chemistry panel, where it files most

How often FDA has decided Advanced Medical Devices, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Advanced Medical Devices, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Advanced Medical Devices, 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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Which product codes does it file in?

  • CGAGlucose Oxidase, Glucose1decision
  • ELCScaler, Ultrasonic1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K982793Piezo TronicAdvanced Medical Devices, Inc. · 1998
  • K960337Amd Home Health Monitoring SystemAdvanced Medical Devices, Inc. · 1996

All 2 as Advanced Medical Devices, Inc. →