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Vascutek, Ltd.

4 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Gelsoft Plus, REF: 635024PE, 631514PE, 631222PE, 633008PE, 633010PE, 633007PE, 636010PE, 6 recall (Z-1492-2026)Vascutek, Ltd.2026-03-04
Gelseal Straight Diameter 8mm Length 15cm. Vascular graft prosthesis is an implanted devic recall (Z-1912-2015)Vascutek, Ltd.2015-06-26
Gelseal Straight Diameter 8mm Length 30cm. Vascular graft prosthesis is an implanted devic recall (Z-1913-2015)Vascutek, Ltd.2015-06-26
Gelweave (TM) Vascular Prostheses Manufactured by - VASCUTEK Ltd a TERUMO company recall (Z-2266-2014)Vascutek, Ltd.2014-08-18

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