5 results
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19ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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Vitek 2 Gram Positive Susceptibility Test Cards (AST-P636 REF 417951), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed in the Product Information manual.
FDA Enforcement
Class I
·Terminated·Biomerieux Inc·May 18, 2016
PROPONENT SR SL (Model L200)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
INTUA CRT-P, Model Numbers: a) V272 b) V273 c) W273
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
EMBLEM S-ICD Model A209
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·February 17, 2021
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) (GTIN 00085412091570); Model Numbers: 35700BAX and 35700ABB. Intended to be used for the controlled administration of fluids.
FDA Enforcement
Class II
·Terminated·Baxter Healthcare Corporation·March 21, 2018