4 results
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17ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI 550 MD, Rx Only
FDA Enforcement
Class II
·Ongoing·UIH Technologies LLC·October 29, 2025
ProVue Instrument Driver for JResultNet (ProVue.jrm) v. 1.5.3 and below JResultNet is a stand-alone software package that provides connectivity between in-vitro diagnostic instruments (IVDs) and Laboratory Information Systems (LIS) aiding the flow of laboratory information, including test orders and results, specimen information, and patient information.
FDA Enforcement
Class II
·Terminated·Data Innovations, LLC·September 24, 2014
AngioDynamics Soft Vu Omni Flush Angiographic Catheter Model Number: 10732203
FDA Enforcement
Class I
·Terminated·Stryker Sustainability Solutions·July 27, 2016
ARGENT SURGICAL SYSTEMS***BIOPSY Punches*** Disposable manual instrument for skin biopsy.
FDA Enforcement
Class II
·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013