510(k) Report

FDA applicant

Human Med AG

Schwerin, DE2 decisions2008–20101 recall

FDA records 2 decisions for Human Med AG (Schwerin, DE) from 2008 to 2010: 2 510(k) clearances. Most are in product codes MUU (System, Suction, Lipoplasty) and QPB (System, Suction, Lipoplasty For Removal). Its devices cite 5 predicates, 0 of them its own earlier devices. 1 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 Human Med AG’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2008: 12010: 1
2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2024

2024: 1
2008high 1 (2024) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Human Med AG by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Human Med AG’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 “Human”

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