510(k) Report

FDA applicant

Amg Medical, Inc.

Canada, CA2 decisions1994–20060 recalls

FDA records 2 decisions for Amg Medical, Inc. (Canada, CA) from 1994 to 2006: 2 510(k) clearances. Most are in product codes FLK (Thermometer, Clinical Mercury) and IOR (Wheelchair, Mechanical). 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, general hospital panel, where it files most

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

FDA decisions per year

No FDA decision for Amg Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Amg Medical, 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) Report

Which product codes does it file in?

  • FLKThermometer, Clinical Mercury1decision
  • IORWheelchair, Mechanical1decision

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?

  • K052548Urok Rocking Wheelchair, Model 700-4XXAmg Medical, Inc. · 2006
  • K940380Amg Med Brand Clinical Glass ThermometerAmg Medical, Inc. · 1994

All 2 as Amg Medical, Inc. →