2 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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Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053
FDA Enforcement
Class II
·Ongoing·AtriCure, Inc.·February 7, 2024
Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare Inc·May 13, 2015