510(k) Report

FDA applicant

Geomed Medizin-Technik GmbH & Co.

Tuttlingen, DE4 decisions2005–20202 recalls

FDA records 4 decisions for Geomed Medizin-Technik GmbH & Co. (Tuttlingen, DE) from 2005 to 2020: 4 510(k) clearances. Most are in product codes GWG (Endoscope, Neurological) and JAQ (System, Applicator, Radionuclide…). Its devices cite 5 predicates, 0 of them its own earlier devices. 2 recalls are linked to its devices.

FDA’s records also spell it “Geomed Medizin-Technik GmbH & Co. KG”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Geomed Medizin-Technik GmbH & Co.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2010: 12019: 12020: 1
2007high 1 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2019

2011: 12019: 1
2007high 1 (2011) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Geomed Medizin-Technik GmbH & Co. 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?

  • GWGEndoscope, Neurological1decision
  • JAQSystem, Applicator, Radionuclide, Remote-Controlled1decision
  • DWPDilator, Vessel, Surgical1decision
  • DXCClamp, Vascular1decision

Whose devices does it build on?

Its devices cite 5 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K183438Geomed Vascular DilatorsGeomed Medizin-Technik GmbH & Co. · 20191cites it

What has FDA decided for it lately?

  • K201279ASSISTO Universal Applicator Clamping DeviceGeomed Medizin-Technik GmbH & Co. KG · 2020
  • K183438Geomed Vascular DilatorsGeomed Medizin-Technik GmbH & Co. · 2019
  • K102048Atraumatic Vascular ClampsGeomed Medizin-Technik GmbH & Co. KG · 20101 recall
  • K052745Assisto Arm SystemsGeomed Medizin-Technik GmbH & Co. · 20051 recall

All 2 as Geomed Medizin-Technik GmbH & Co. →All 2 as Geomed Medizin-Technik GmbH & Co. KG →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K102048Integra Jarit GEMINI CLAMP 9 1/4 inch - used in vascular and cardiothoracic procedures…Aug 7, 2019Class II
  • K052745ASSISTO Arm System Table-mounted self retaining instrument holder system consisting of…Dec 16, 2011