CORELEADER HYDRO-HEALER HYDROCOLLOID WOUND DRESSING— 510(k) K123394

Substantially Equivalent

Coreleader Biotech Co., Ltd.

FDA 510(k) clearance K123394 for CORELEADER HYDRO-HEALER HYDROCOLLOID WOUND DRESSING, Substantially Equivalent on 2013-06-06. Applicant: Coreleader Biotech Co., Ltd..

Clearance details

Applicant: Coreleader Biotech Co., Ltd.
Product code: Code FRO
Advisory panel: Unknown
Date received: 2012-11-02
Decision date: 2013-06-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Taipei, Taiwan, TW

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Adverse events under product code FRO

product code FRO

Death: 30
Injury: 653
Malfunction: 479
Other: 11
Total: 1,173

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.