2 results
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11ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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The Ultem Polymeric Resin Koh Cup is a non- sterile, reusable vaginal fornices delineator. It is made of medical grade plastics and not made with natural rubber latex. Model Number(s): KCP-30-2
FDA Enforcement
Class II
·Ongoing·CooperSurgical, Inc.·June 2, 2021
Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: CABG OPNHRT S HSP, CARDIAC CABG, CARDIAC PACK, DR D AC PACK, HEART BASIN PACK-LF, K OH COMPONENT PACK, OPEN HEART ADULT PART 1 CDS, OPEN HEART B PACK-LF, OPEN HEART PACK, Z OPEN HEART.
FDA Enforcement
Class I
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·April 16, 2025