OMI RETRACTABLE SAFETY SYRINGE— 510(k) K060109

Substantially Equivalent

Vitalcare Group, Inc.

FDA 510(k) clearance K060109 for OMI RETRACTABLE SAFETY SYRINGE, Substantially Equivalent on 2006-05-05. Applicant: Vitalcare Group, Inc..

Clearance details

Applicant: Vitalcare Group, Inc.
Product code: Code MEG
Advisory panel: General Hospital
Date received: 2006-01-13
Decision date: 2006-05-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Deer Field, IL, US

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Adverse events under product code MEG

product code MEG

Malfunction: 1,373
Other: 1
Total: 1,374

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.