3 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality control and calibration samples on the Access 2 Immunoassay system, Catalog Number 81901
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·December 17, 2025
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTS
FDA Enforcement
Class II
·Ongoing·Covidien, LP·April 10, 2024
MOLLI 2 System System includes: MM1000 (Pack of 10) - MOLLI Introducer (8cm, 14G) and MOLLI Marker UDI (GTIN): 00850024195028 MS-00009 (Pack of 10) - MOLLI Introducer (12cm, 14G) and MOLLI Marker UDI (GTIN): 00850024195134 MP2001 - MOLLI 2 Wand UDI (GTIN): 00850024195141 MP2015A - MOLLI OncoPen UDI (GTIN): 00850024195219 MT2001 - MOLLI 2 Tablet UDI (GTIN): 00850024195158 The MOLLI Marker is intended to be placed percutaneously in soft tissue to temporarily mark a surgical site intended for surgical removal. the MOLLI Marker is located and surgically removed with the target tissue.
FDA Enforcement
Class II
·Ongoing·Stryker Corporation·February 25, 2026