4 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Waste Collection Kit. Label reads in part: ''CUSTOM KIT...MERIT MEDICAL''. Latex free, Sterile if package is unopened or undamaged. Part # K10-01047.
FDA Recall
Terminated
·Merit Medical Systems, Inc·Product code DQO·October 1, 2003
E-Z WIDER BARIATRIC CHAIR BED; Single Motion Expandable Width Technology
FDA Enforcement
Class II
·Terminated·Kreg Medical Inc.·June 12, 2013
Tecan clinical workstation; Tecan Genesis 150/8 front end COBAS, Roche catalog number 03600530001.
FDA Recall
Terminated
·Roche Diagnostics Corp.·Product code JQW·May 5, 2004
CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).
FDA Enforcement
Class II
·Terminated·CME America, LLC·December 9, 2020