7 results
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39ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Italy
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MuoviPro 128
Device
EU MDR
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Eu Md Class 1
·OT Bioelettronica srl·On the market
Muovi+Pro 128
Device
EU MDR
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Eu Md Class 1
·OT Bioelettronica srl·On the market
ComASP Cefiderocol 0.008-128
FDA 510(k)
FDA Class 2
·Microbiology
MTS Ampicillin-Sulbactam 0.016/0.008 - 256/128 µg/mL
FDA 510(k)
FDA Class 2
·Microbiology
WASP (Walk Away Specimen Process). Automatic Planting and Streaking Instrument Catalog number: W086 WASP is a fully automated system used to process microbiological specimens in liquid phase for the investigation of infectious microbes.
FDA Enforcement
Class III
·Terminated·Copan Italia·September 11, 2013
SD LTM 64 PLUS, EEG Amplifier/recorder, Model/Catalog Number: SD LTM 64 PLUS, Software Version: firmware 2021.02, 2022.01 or 2022.02
FDA Enforcement
Class II
·Ongoing·Micromed S.p.A.·June 17, 2026
THERMI250 Radiofrequency System. Intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions.
FDA Enforcement
Class II
·Terminated·Bios S.r.l.·November 8, 2017