4 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
FDA Enforcement
×
Aligned Medical Solutions, Local Lower Extremity Pack I, AMS10833, STERILEEO
FDA Enforcement
Class I
·Ongoing·Windstone Medical Packaging, Inc.·February 28, 2024
IntelliSpace PACS 4.4, Product number 837507 - Product Usage: intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians.
FDA Enforcement
Class II
·Completed·Philips Healthcare Informatics, Inc.·June 17, 2020
ROSA Brain 3.0 Application-Brain
FDA Enforcement
Class II
·Terminated·MEDTECH SAS·February 19, 2020
Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020. Additional kits produced through February 19, 2020 were included.
FDA Enforcement
Class II
·Terminated·Cardinal Health 200, LLC·February 26, 2020