4 results
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21ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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Monoject 0.9% Saline Flush Prefill Double Pouch Item Code: 8881570129 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access devices.
FDA Enforcement
Class II
·Terminated·Covidien LLC·September 9, 2015
RT-5100 Refractor, a component of the Epic-5100 System.
FDA Enforcement
Class III
·Terminated·Nidek Inc.·December 26, 2018
BladderScan Prime Plus Probe REF 0570-0395 - Product Usage: intended to be used for measuring the urine volume in the bladder noninvasively.
FDA Enforcement
Class II
·Terminated·Verathon, Inc.·December 9, 2020
System Material # Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee multi-purpose 10094139 Artis zee biplane 10094141 Artis zeego 10280959 Artis Q floor 10848280 Artis Q ceiling 10848281 Artis Q biplane 10848282 Artis Q.zeego 10848283 Artis Q.zen floor 10848353 Artis Q.zen ceiling 10848354 Artis Q.zen biplane 10848355 Fluoroscopic X-Ray System
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·February 8, 2023