510(k) Report

FDA applicant

Gammamed USA

Ann Arbor, MI1 decision1998–199817 recalls

FDA records 1 decision for Gammamed USA (Ann Arbor, MI) in 1998: 1 510(k) clearance. All are in product code JAQ (System, Applicator, Radionuclide…). Its devices cite 1 predicate, 0 of them its own earlier devices. 17 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, radiology panel, where it files most

How often FDA has decided Gammamed USA’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Gammamed USA since 2007.

Recalls per year

1in 2012

2008: 42011: 102012: 1
2007high 10 (2011) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Gammamed USA 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?

  • JAQSystem, Applicator, Radionuclide, Remote-Controlled1decision

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 13 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.

  • K983436Gammamed Plus High Dose Rate Remote Afterloading SystemGammamed USA · 199813cite it

What has FDA decided for it lately?

  • K983436Gammamed Plus High Dose Rate Remote Afterloading SystemGammamed USA · 199817 recalls

The one decision as Gammamed USA →

What has been recalled?

17 recalls linked to its devices; the latest:

  • K983436Segmented Cervix Applicator Set, part number GM11004310, a component used with the tube…Sep 28, 2012Class II
  • K983436Titanium Fletcher-style Applicator Set - Defined Geometry - CT Compatible with Titanium…Jul 13, 2011
  • K983436Titanium Fletcher-style Applicator Set - Defined Geometry - CT Compatible with Titanium…Jul 13, 2011
  • K983436Titanium Fletcher-style Applicator Set - Defined Geometry - CT Compatible with Titanium…Jul 13, 2011
  • K983436GammaMed Plastic Needle with Mandrin; 2.0mm diameter, length 200 mm. Remote controlled…Jul 13, 2011
  • K983436Titanium Fletcher-style Applicator Set - Defined Geometry - CT Compatible with Titanium…Jul 13, 2011