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ETHICON, LLC

6 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device, SFX SPI PDS+ BI VI recall (Z-2605-2025)ETHICON, LLC2025-09-19
PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is i recall (Z-1096-2025)Ethicon, LLC2025-02-04
PERMA-HAND Silk Suture, REF: K872H, W723H, 623H, K833H; Perma-hand Silk Suture is indicate recall (Z-1097-2025)Ethicon, LLC2025-02-04
ETHIBOND EXCEL Polyester Suture, REF: 6664H, X425H, X872H, EH7491H. Not sold in US recall (Z-1098-2025)Ethicon, LLC2025-02-04
PDS Plus Antibacterial (polydioxanone) Suture, Product Numbers PDP072H40, PDP259H50, PDP41 recall (Z-2616-2023)ETHICON, LLC2024-09-30
PDS II (polydioxanone) Suture, Product Numbers Z844G-50, D10065-05, D10085-05, D6776-05, D recall (Z-2617-2023)ETHICON, LLC2024-09-30

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Every clearance here is in the API, with alerts when new ones post.