CAREO SAFETY SYRINGE (3CC/ML, 5CC/ML, 10CC/ML)— 510(k) K052397

Substantially Equivalent

Life-Shield Products, Inc.

FDA 510(k) clearance K052397 for CAREO SAFETY SYRINGE (3CC/ML, 5CC/ML, 10CC/ML), Substantially Equivalent on 2005-12-22. Applicant: Life-Shield Products, Inc..

Clearance details

Applicant: Life-Shield Products, Inc.
Product code: Code MEG
Advisory panel: General Hospital
Date received: 2005-08-31
Decision date: 2005-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei, TW

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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.