7 results · 11ms · Sources: EU EUDAMED, US FDA

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CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281

FDA Enforcement
Class II ·Ongoing·Beckman Coulter Mishima K.K.·March 18, 2026

DxC 700 AU, REF: B86444, B86446

FDA Enforcement
Class II ·Ongoing·Beckman Coulter Mishima K.K.·March 18, 2026

DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only.

FDA Enforcement
Class II ·Ongoing·Beckman Coulter Mishima K.K.·August 7, 2024

DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only.

FDA Enforcement
Class II ·Ongoing·Beckman Coulter Mishima K.K.·August 28, 2024

Product Name: GCX Channel Mounting Accessory Model/Catalog Number: H8-300-40-A

FDA Enforcement
Class II ·Ongoing·Skytron, Div. The KMW Group, Inc·July 6, 2022

Skyton Bracket Flatscreen, Revision 2 & 3-The FS32 is a single monitor mounting bracket intended for use with a 32 inch (maximum) flat screen monitor. Model: FS32

FDA Enforcement
Class II ·Ongoing·Skytron, Div. The KMW Group, Inc·June 23, 2021

Skytron Ergon 3 Series Skyboom Monitor Bracket-Flatscreen Bracket, single monitor mount, 27" max. screen size Part number 3FCM1

FDA Enforcement
Class II ·Ongoing·Skytron, Div. The KMW Group, Inc·April 1, 2020