4 results
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12ms
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Sources: EU EUDAMED, US FDA
The GLOBAL UNITE Platform Shoulder System is intended for cemented or uncemented total shoulder or hemi-shoulder replacement procedures, Product labeling: LE¿O-1100-30-000 REV D.pdf.pdf, LE¿O-1100-40-000 REV D.pdf.pdf, LE¿O-110030100_REV D.pdf.pdf, LE¿O-110030110_REV D.pdf.pdf, LE¿O-110030120_REV D.pdf.pdf
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·March 21, 2018
ARTIS Pheno, Fluoroscopic X-Ray system, Model Number 10849000
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·August 1, 2018
EPIDURAL CATHETERIZATION KIT, Product Code AT-05501-LEO
FDA Enforcement
Class II
·Terminated·Arrow International Inc·February 19, 2020
The Fresenius APD Luer-Lock Adapter, Catalog number 050-95018, is designed to connect a peritoneal dialysis bag equipped with a luer-lock connector to a Fresenius Automated Peritoneal Dialysis (APD) cycler set that uses the Fresenius Safe-Lock¿ connector (e.g., Liberty¿ cycler, Newton IQO cycler).
FDA Enforcement
Class II
·Terminated·Fresenius Medical Care Holdings, Inc.·July 28, 2021