510(k) Report

FDA applicant

Technosanat Innovative Medizintechnik GmbH

Irvine, CA1 decision1999–19990 recalls

FDA records 1 decision for Technosanat Innovative Medizintechnik GmbH (Irvine, CA) in 1999: 1 510(k) clearance. All are in product code GEX (Powered Laser Surgical Instrument). 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

No FDA decision for Technosanat Innovative Medizintechnik GmbH since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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