8 results
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7ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Reagent Management System (RMS) Dimension RxL Max w/o HM Product Usage: The Reagent Management System (RMS) is a module for use with the Dimension¿ clinical chemistry system. The RMS doubles the available storage of refrigerated Flex¿ reagent cartridges on the Dimension¿ system from 44 to 88. The RMS loads, hydrates, and automatically removes Flex¿ reagent cartridges, allowing the Dimension¿ system to process samples without interruption.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics Inc.·December 30, 2015
Spacelabs Ultraview DM4 Vital Signs Monitor (all variations -M, -N, -MF, -NF, -MW, -NW, -MFW, -NFW), Model Number 91331
FDA Enforcement
Class II
·Ongoing·Zoe Medical Incorporated·September 18, 2024
Baxter Operating Table TruSystem 7000 (MBW), Product code REF 1841048
FDA Enforcement
Class II
·Ongoing·Baxter Healthcare Corporation·October 30, 2024
Baxter Operating Table TruSystem 7000 U14 (MBW), Product code REF 2065385
FDA Enforcement
Class II
·Ongoing·Baxter Healthcare Corporation·October 30, 2024
Baxter Operating Table TruSystem 7000 (MBW) V, Product code REF 1841082
FDA Enforcement
Class II
·Ongoing·Baxter Healthcare Corporation·October 30, 2024
Baxter Operating Table TruSystem 7000 U14 (MBW) V, Product code REF 2065386
FDA Enforcement
Class II
·Ongoing·Baxter Healthcare Corporation·October 30, 2024
MEDLINE ReNewal ENT Coblator II PROcise mAx,W/ Integrated Cable Suction & Saline (Blue), Item Number REF EICA88980R
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·April 16, 2025
Dimension Thermal Chamber Motor Cable located in the following models: Model/UDI Number: Dimension¿ EXL 200 00630414593579; Dimension¿ EXL with LM 00630414593500; Dimension¿ EXL with LM with STM 00630414593593; Dimension¿ RxL Max 00630414949789; Dimension¿ RxL Max HM 00630414949796; Dimension¿ RxL Max HM STM 00630414949819; Dimension¿ Xpand¿ Plus 00630414949833; Dimension¿ Xpand¿ Plus HM 00630414949840; Dimension¿ RxL Max Refurbished 00630414592947; Dimension¿ RxL Max HM Refurbished 00630414592954; Dimension¿ Xpand¿ Plus Refurbished 00630414592961; Dimension¿ Xpand¿ Plus HM Refurbished 00630414592978; Dimension¿ EXL with LM Refurbished 00630414000268; Dimension¿ 200 Refurbished 00630414010717;; Dimension¿ RxL Max w/o HM International 00630414949802; Dimension¿ RxL Max HM International 00630414945477; Dimension¿ RxL Max HM STM International 00630414949826; Dimension¿ Xpand Plus w/o HM International 00630414949857; Dimension¿ Xpand Plus w/HM International 00630414945484; Dimension¿ EXL with LM International 00842768030024; Dimension¿ EXL 200 International 00842768037214 Dimension¿ EXL with LM with STM International 00630414593609 The Dimension motor assembly is used in the Dimension Thermal Chamber Fan (ASSY BLOWER SNOUT) and is responsible for the intake and circulation of air inside the "Wok," a chamber within the Dimension instrument which enables greater temperature control of the testing environment.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·November 14, 2018