510(k) K100994— PRELOADED TISSUE MARKER DEVICE

Substantially Equivalent

Carbon Medical Technologies, Inc.

Clearance details

Applicant: Carbon Medical Technologies, Inc.
Product code: Code NEU
Advisory panel: General, Plastic Surgery
Date received: 2010-04-09
Decision date: 2010-04-30
Decision: Substantially Equivalent
Clearance type: Special
Location: St. Paul, MN, US

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.