510(k) Report

FDA applicant

Inomed Medizintechnik GmbH

Emmendingen, DE11 decisions1991–20262 recalls

FDA records 11 decisions for Inomed Medizintechnik GmbH (Emmendingen, DE) from 1991 to 2026: 11 510(k) clearances. Most are in product codes ETN (Stimulator, Nerve) and GWF (Stimulator, Electrical, Evoked Response). Its devices cite 17 predicates, 4 of them its own earlier devices. 2 recalls are linked to its devices.

FDA’s records also spell it “inomed Medizintechnik GmbH”.

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

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

How often FDA has decided Inomed Medizintechnik GmbH’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2009: 12011: 12016: 12022: 22023: 22025: 12026 (partial year): 1
2007high 2 (2022) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

2in 2019

2019: 2
2007high 2 (2019) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Inomed Medizintechnik 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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Other applicant names beginning “Inomed”

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