8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BIOSIGN FLU A + B, STATUS FLU A & B
FDA 510(k)
FDA Class 2
·Microbiology
Oticon
FDA UDI
Oticon A/S·05707131261762·H10, BTE 13 WL 85 DBL
ZOLL AED PLUS
FDA 510(k)
FDA Class 3
·Cardiovascular
ENA TEMP AND ENAMEL PLUS TEMP (TWO DIFFERENT PROPRIETARY NAMES FOR THE SAME PRODUCT)
FDA 510(k)
FDA Class 2
·Dental
MQUATTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 20, 2013
EON MINI RECHARGEABLE IPG
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 15, 2011
JAGTOME RX SPHINCTEROTOME
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·August 22, 2008
Achieva 1.5T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·November 29, 2023