KENDALL ULTEC PRO AG+ HYDROCOLLOID DRESSING— 510(k) K033453

Substantially Equivalent

Tyco Healthcare

FDA 510(k) clearance K033453 for KENDALL ULTEC PRO AG+ HYDROCOLLOID DRESSING, Substantially Equivalent on 2004-04-29. Applicant: Tyco Healthcare.

Clearance details

Applicant: Tyco Healthcare
Product code: Code FRO
Advisory panel: Unknown
Date received: 2003-10-30
Decision date: 2004-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mansfield, MA, US

Download summary PDF View on FDA.gov ↗

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.