4 results
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21ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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A&E Medical Thorecon Plating System Kits Model No. 94-1500-04-S. For fracture fixation or reconstruction of the sternum.
FDA Enforcement
Class II
·Terminated·Alto Development Corp·November 6, 2019
HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF CI-1500-04. Cochlear Implant.
FDA Enforcement
Class III
·Terminated·Advanced Bionics, LLC·February 26, 2020
Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality control and calibration samples on the Access 2 Immunoassay system, Catalog Number 81901
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·December 17, 2025
BladderScan Prime Plus Probe REF 0570-0395 - Product Usage: intended to be used for measuring the urine volume in the bladder noninvasively.
FDA Enforcement
Class II
·Terminated·Verathon, Inc.·December 9, 2020