6 results
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7ms
·
Sources: EU EUDAMED, US FDA
IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi BR-MA (CA15-3)
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·May 16, 2018
IMMULITE ¿ /IMMULITE ¿ 1000 BR-MA (CA15-3)
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·May 16, 2018
Medonic M-Series Hematology Analyzer M16S BD ABR US Product code: 1400075; OUS Product code 1400011
FDA Enforcement
Class II
·Terminated·Clinical Diagnostic Solutions, Inc.·February 12, 2020
Instructions for Use for all model numbers of the Medtronic Abre Venous Self-Expanding Stent System.
FDA Enforcement
Class II
·Terminated·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·January 12, 2022
Medtronic Abre Venous Self-expanding Sent System, Catalog number REF AB9U16080090 - Product Usage: intended for use in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction.
FDA Enforcement
Class II
·Terminated·Medtronic Inc.·May 12, 2021
ROI-A Anterior Delivery Device. Orthopedic manual surgical instrument. Model number: SI-ROIA-0023 Auxiliary instrument used in the ROI-A-ALIR cage system: Spinal intervertbral body fusion device.
FDA Enforcement
Class II
·Terminated·LDR Spine USA, Inc.·October 12, 2016