510(k) Report

FDA applicant

American Medical Devices, Inc.

Atlanta, GA6 decisions1997–19980 recalls

FDA records 6 decisions for American Medical Devices, Inc. (Atlanta, GA) from 1997 to 1998: 6 510(k) clearances. Most are in product codes MPA (Endoilluminator) and HJK (Lens, Contact, Polymethylmethacrylate…). 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, ophthalmic panel, where it files most

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

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • MPAEndoilluminator3decisions
  • HJKLens, Contact, Polymethylmethacrylate, Diagnostic1decision
  • KYGDevice, Irrigation, Ocular Surgery1decision
  • HMXCannula, Ophthalmic1decision

Whose devices does it build on?

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

Who builds on its devices?

Later devices cite its devices 3 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K970882Endolight End Irrigating Endo-Illuminator (20 GA. and 19 GA.)American Medical Devices, Inc. · 19973cite it

What has FDA decided for it lately?

  • K974561Moistair Fluid Air Tubing SetAmerican Medical Devices, Inc. · 1998
  • K971853Endoview Spphire Lens SetAmerican Medical Devices, Inc. · 1997
  • K970882Endolight End Irrigating Endo-Illuminator (20 GA. and 19 GA.)American Medical Devices, Inc. · 1997
  • K970875Endolight Fiberoptic Endo-Illuminator (20 GA. & 19 GA.)American Medical Devices, Inc. · 1997
  • K970873Endosoft Soft Tip Needle (20 GA. and 19 GA.)American Medical Devices, Inc. · 1997
  • K970878Endolight Fiberoptic Regular Monofilament and Fine MonofilamentAmerican Medical Devices, Inc. · 1997

All 6 as American Medical Devices, Inc. →