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Biodesign

COOK BIOTECH INCORPORATED · Model G12848 · UDI-DI 10827002128481

FTM Prescription
2
510(k) clearances
11,594
Adverse events (47 deaths)
76
Recalls
89
Facilities

Description

Biodesign 4-Layer Tissue Graft

Recalls

DateFirmReason
2024-08-07Cook Biotech, Inc.Products expire prior to the expiration date printed on the product labeling
2024-08-07Cook Biotech, Inc.Products expire prior to the expiration date printed on the product labeling
2024-08-07Cook Biotech, Inc.Products expire prior to the expiration date printed on the product labeling
2024-08-07Cook Biotech, Inc.Products expire prior to the expiration date printed on the product labeling
2024-08-07Cook Biotech, Inc.Products expire prior to the expiration date printed on the product labeling
2024-08-07Cook Biotech, Inc.Products expire prior to the expiration date printed on the product labeling
2024-08-07Cook Biotech, Inc.Products expire prior to the expiration date printed on the product labeling
2024-08-07Cook Biotech, Inc.Products expire prior to the expiration date printed on the product labeling
2024-08-07Cook Biotech, Inc.Products expire prior to the expiration date printed on the product labeling
2024-08-07Cook Biotech, Inc.Products expire prior to the expiration date printed on the product labeling

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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.