510(k) Report

FDA applicant

Geister Medizin Technik GmbH

Tuttlingen, DE6 decisions1994–20250 recalls

FDA records 6 decisions for Geister Medizin Technik GmbH (Tuttlingen, DE) from 1994 to 2025: 6 510(k) clearances. Most are in product codes HAE (Rongeur, Manual) and GEI (Electrosurgical, Cutting & Coagulation &…). Its devices cite 6 predicates, 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, cardiovascular panel, where it files most

How often FDA has decided Geister Medizin Technik GmbH’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2018: 12025: 1
2007high 1 (2018) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Geister Medizin Technik GmbH by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Geister Medizin Technik GmbH’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • HAERongeur, Manual1decision
  • GEIElectrosurgical, Cutting & Coagulation & Accessories1decision
  • GZTRetractor, Self-Retaining, For Neurosurgery1decision
  • DXCClamp, Vascular1decision
  • MGZValvulotome1decision
  • DWPDilator, Vessel, Surgical1decision

Whose devices does it build on?

Its devices cite 6 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 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.

  • K030788Kamar Annulus Dilator + Sizer; Garrett, Cooley, and Debakey Vessel DilatorsGeister Medizin Technik GmbH · 20033cite it
  • K180610Geister retractor for neuro - and spine surgeryGeister Medizin Technik GmbH · 20181cites it

What has FDA decided for it lately?

  • K242759Geister K-Rex rongeursGeister Medizin Technik GmbH · 2025
  • K180610Geister retractor for neuro - and spine surgeryGeister Medizin Technik GmbH · 2018
  • K022823Valvulotome, Retrograde : 03-7500- 03-7510, Antegrade 03-7520Geister Medizin Technik GmbH · 2004
  • K030788Kamar Annulus Dilator + Sizer; Garrett, Cooley, and Debakey Vessel DilatorsGeister Medizin Technik GmbH · 2003
  • K982365Atraumatic Vascular Clamps, Model #'S 22-XXXX, 23-XXXX, 03-60XX, 25-XXXX Micro Vascular Clamps Model #…Geister Medizin Technik GmbH · 1999
  • K933699Geister Surgical Int'l Bipolar Endoscopic Surgical InstrumentsGeister Medizin Technik GmbH · 1994

All 6 as Geister Medizin Technik GmbH →