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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Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 150030
FDA Enforcement
Class I
·Ongoing·TELEFLEX LLC·July 5, 2023
Micro Screen 6 Panel Cup with Adult (AU), Item No. MSCA-6MBAU These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use. ¿¿¿
FDA Enforcement
Class II
·Terminated·Ameditech Inc·November 25, 2015
Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number (SMN): 11574002; With Software Version VB10D-SP02
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·February 4, 2026
RT-5100 Refractor, a component of the Epic-5100 System.
FDA Enforcement
Class III
·Terminated·Nidek Inc.·December 26, 2018