MODIFICATION TO BIOMARC TISSUE MARKER— 510(k) K063193

Substantially Equivalent

Carbon Medical Technologies, Inc.

FDA 510(k) clearance K063193 for MODIFICATION TO BIOMARC TISSUE MARKER, Substantially Equivalent on 2006-11-21. Applicant: Carbon Medical Technologies, Inc..

Clearance details

Applicant: Carbon Medical Technologies, Inc.
Product code: Code NEU
Advisory panel: General, Plastic Surgery
Date received: 2006-10-20
Decision date: 2006-11-21
Decision: Substantially Equivalent
Clearance type: Special
Location: St. Paul, MN, US

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Adverse events under product code NEU

product code NEU

Injury: 824
Total: 824

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.