510(k) Report

FDA applicant

Stihler Electronic GmbH

Sound Beach, NY7 decisions1999–20263 recalls

FDA records 7 decisions for Stihler Electronic GmbH (Sound Beach, NY) from 1999 to 2026: 7 510(k) clearances. Most are in product codes BSB (Warmer, Blood, Non-Electromagnetic Radiation) and DWJ (System, Thermal Regulating). Its devices cite 6 predicates, 2 of them its own earlier devices. 3 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, hematology panel, where it files most

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

FDA decisions per year

1in 2020

2008: 22020: 12026 (partial year): 1
2007high 2 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

3in 2018

2018: 3
2007high 3 (2018) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Stihler Electronic 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 “Stihler”

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