510(k) Report

FDA applicant

Heinz Kurz

Dusslingen, DE5 decisions1997–20010 recalls

FDA records 5 decisions for Heinz Kurz (Dusslingen, DE) from 1997 to 2001: 5 510(k) clearances. Most are in product codes ETB (Prosthesis, Partial Ossicular Replacement) and KHJ (Polymer, Ent Synthetic-Polyamide (Mesh Or Foil…). Its devices cite 4 predicates, 1 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, ear, nose and throat panel, where it files most

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

FDA decisions per year

No FDA decision for Heinz Kurz since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Heinz Kurz 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?

  • ETBProsthesis, Partial Ossicular Replacement4decisions
  • KHJPolymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)1decision

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 9 times; 1 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.

  • K972492Bell Prosthesis (Partial)Heinz Kurz · 19976cite it
  • K990923Tubingen Titanium Prosthesis (TTP) Vario, Models Aerial 1004 010 & Bell 1002 010Heinz Kurz · 19993cite it

What has FDA decided for it lately?

  • K010442Kurz Angular Piston-Titanium Prosthesis, Models 1006 600, 1006 601, 1006 602, 1006 650, 1006 651, 1006 652Heinz Kurz · 2001
  • K991324Titanium Vocal Fold Medializing Implant, Models 5001 001 (Female), and 5001 003 (Male)Heinz Kurz · 1999
  • K990923Tubingen Titanium Prosthesis (TTP) Vario, Models Aerial 1004 010 & Bell 1002 010Heinz Kurz · 1999
  • K973356K-Piston with Band Hook /Angular PistonHeinz Kurz · 1997
  • K972492Bell Prosthesis (Partial)Heinz Kurz · 1997

All 5 as Heinz Kurz →

Other applicant names beginning “Heinz”

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

Heinz Kurz GmbH Medizintechnik 14