510(k) Report

FDA applicant

Heinz Kurz GmbH Medizintechnik

Amsterdam, Nh, NL14 decisions1997–20130 recalls

FDA records 14 decisions for Heinz Kurz GmbH Medizintechnik (Amsterdam, Nh, NL) from 1997 to 2013: 14 510(k) clearances. Most are in product codes ETB (Prosthesis, Partial Ossicular Replacement) and MML (Weights, Eyelid, External). Its devices cite 14 predicates, 8 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 GmbH Medizintechnik’s devices, and how often a recall has named them.

FDA decisions per year

2in 2013

2007: 12013: 2
2007high 2 (2013) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Heinz Kurz GmbH Medizintechnik 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 Replacement6decisions
  • MMLWeights, Eyelid, External3decisions
  • ETDTube, Tympanostomy2decisions
  • ETAReplacement, Ossicular Prosthesis, Total2decisions
  • KHJPolymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)1decision

Whose devices does it build on?

Its devices cite 14 predicates; 8 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 22 times; 8 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.

  • K021479Clip Piston Awengen, Model# 1006 805 - 1006 861Heinz Kurz GmbH Medizintechnik · 20025cite it
  • K002221Kurkz K-Piston Titanium Stapedial Prosthesis, Model 1006 103-1006 170Heinz Kurz GmbH Medizintechnik · 20004cite it
  • K972585Aerial Prosthesis, Aerial Prosthesis, Model Dusseldorf, Dresden Aerial Prosthesis, Aerial Prosthesis, Model…Heinz Kurz GmbH Medizintechnik · 19974cite it
  • K042503Kurz Clip Piston MVP, Model 1006 711-13/0.4 MM + 1006 761-63/0.6MMHeinz Kurz GmbH Medizintechnik · 20042cite it
  • K973226Tubingen Tympanic Ventilation Tube, Tympanic Ventilation Tubes with Ene/S, Diabolo Tympanic Ventilation…Heinz Kurz GmbH Medizintechnik · 19971cites it
  • K013573Clip Partial Prosthesis-Titanium Dresden, Model 1002 250-257Heinz Kurz GmbH Medizintechnik · 20011cites it

What has FDA decided for it lately?

  • K130512Nitiflex Stapes Prosthesis, Detroit Piston, Skarzynski Piston, Roberson Stapes ProsthesisHeinz Kurz GmbH Medizintechnik · 2013
  • K112616Nitibond Stapes Prosthesis, Nitiplast Stapes ProsthesisHeinz Kurz GmbH Medizintechnik · 2013
  • K071150Trocar Ventilation Tube/with Trocar Tip, Trocar Handle, Model 1015 074, 1015 076, 1015 075, 1015 077, W/…Heinz Kurz GmbH Medizintechnik · 2007
  • K042503Kurz Clip Piston MVP, Model 1006 711-13/0.4 MM + 1006 761-63/0.6MMHeinz Kurz GmbH Medizintechnik · 2004
  • K033796Kurz Silicone Strips, Models SF-1, SF-1W, SF-1 BSHeinz Kurz GmbH Medizintechnik · 2004
  • K021479Clip Piston Awengen, Model# 1006 805 - 1006 861Heinz Kurz GmbH Medizintechnik · 2002
  • K013573Clip Partial Prosthesis-Titanium Dresden, Model 1002 250-257Heinz Kurz GmbH Medizintechnik · 2001
  • K011115Kurz Upper Eyelid Implant- Platinum/Iridium,Models Regular 4007 003-007, Special 4007 002, 4007 008-010Heinz Kurz GmbH Medizintechnik · 2001

All 14 as Heinz Kurz GmbH Medizintechnik →

Other applicant names beginning “Heinz”

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

Heinz Kurz 5