DYNAREX IODOFORM PACKING STRIPS, MODELS 3411, 3412, 3413, 3414— 510(k) K012816

Substantially Equivalent

Dynarex Corp.

FDA 510(k) clearance K012816 for DYNAREX IODOFORM PACKING STRIPS, MODELS 3411, 3412, 3413, 3414, Substantially Equivalent on 2002-10-17. Applicant: Dynarex Corp..

Clearance details

Applicant: Dynarex Corp.
Product code: Code FRO
Advisory panel: Unknown
Date received: 2001-08-22
Decision date: 2002-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Maineville, OH, US

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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.