4 results
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12ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
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ReadyMed Elastomeric Ambulatory Pump, Model Numbers: R050050, R100100, R100200, R250050, R250100, and R250167. Intended for self-administration of anti-microbial and antiviral agents.
FDA Recall
Terminated
·Cardinal Health 303 dba Cardinal Health·Product code FRN·December 19, 2008
H4051 Endo Tube Holder, Pedi 2.5mm Pediatric Endotracheal Intubation Kit
FDA Enforcement
Class I
·Terminated·Smiths Medical ASD, Inc.·September 3, 2014
Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020
FDA Enforcement
Class II
·Terminated·Cardinal Health 200, LLC·February 26, 2020
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013