SAFETY SHIELD KIT— 510(k) K873731

Substantially Equivalent

Ballard Medical Products

FDA 510(k) clearance K873731 for SAFETY SHIELD KIT, Substantially Equivalent on 1988-01-15. Applicant: Ballard Medical Products.

Clearance details

Applicant: Ballard Medical Products
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 1987-08-10
Decision date: 1988-01-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

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Adverse events under product code FXX

product code FXX

Injury: 137
Total: 137

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.