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Health Support

Carolon Company · Model Below Knee · UDI-DI 00078301201228

FQL
6
510(k) clearances
24
Adverse events
2
Recalls
273
Facilities

Recalls

DateFirmReason
2011-10-07Surgical Appliance IndustriesDuring an audit with the FDA, it was discovered that a new compression testing device used for testing hosiery had been implemented and that the operators were not properly trained
2011-10-07Surgical Appliance IndustriesDuring an audit with the FDA, it was discovered that a new compression testing device used for testing hosiery had been implemented and that the operators were not properly trained

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.