510(k) Report

FDA applicant

Haenglim Seowon Corp.

Flushing, NY1 decision2001–20010 recalls

FDA records 1 decision for Haenglim Seowon Corp. (Flushing, NY) in 2001: 1 510(k) clearance. All are in product code MQX (Needle, Acupuncture, Single Use). 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 hospital panel, where it files most

How often FDA has decided Haenglim Seowon Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Haenglim Seowon Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Haenglim”

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