FDA applicant

Dalim Medical Corp.

Bucheon-Si, KR1 decision2024–20240 recalls

FDA records 1 decision for Dalim Medical Corp. (Bucheon-Si, KR) in 2024: 1 510(k) clearance. All are in product code OTJ (Laparoscopic Single Port Access Device). 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

1in 2024

2024high 1 (2024) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2024.

FIG. 1 — Dalim Medical Corp. by year, 2024–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Dalim Medical Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Dalim”

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

Dalim Surgnet Corporation 2 Dalim Tissen Co., Ltd. 1

Dalim Medical Corp.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Dalim”