FDA applicant

Fibertech GmbH

Mesa, AZ1 decision2005–20055 recalls

FDA records 1 decision for Fibertech GmbH (Mesa, AZ) in 2005: 1 510(k) clearance. All are in product code GEX (Powered Laser Surgical Instrument). Its devices cite 11 predicates, 0 of them its own earlier devices. 5 recalls are 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 Fibertech GmbH’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Fibertech GmbH since 2007.

Recalls per year

5in 2018

2007high 5 (2018) · low 0 (2007)2026

Class I Class II/III not classified

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

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Other applicant names beginning “Fibertech”

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

Fibertech Instruments, Inc. 2

Fibertech GmbH

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Fibertech”