5 results
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18ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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Kit BD Max Enteric Bacterial Panel EU; Catalog # 442963
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·August 28, 2019
Brand Name: Intermate Infusion Pump. Indicated for the intravenous administration of medications.
FDA Enforcement
Class II
·Terminated·Baxter Healthcare Corp.·July 3, 2013
DORO¿ Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002)
FDA Enforcement
Class II
·Ongoing·Pro-Med Instruments Gmbh·June 4, 2025
CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assists the operator in viewing chromosomes and looking for cellular anomalies. CytoVision enables a qualified Cytogeneticist to rapidly and accurately analyze the chromosome banding pattern.
FDA Enforcement
Class III
·Terminated·Leica Biosystems Richmond Inc.·June 29, 2016
EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021