9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CONMED LINVATEC 300W XENON LIGHT SOURCE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
AHL GENERIC GLASS IONOMER AESTHETIC RESTORATIVE
FDA 510(k)
FDA Class 2
·Dental
SPECIALTY 42 (HEFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR, SPECIALTY T-42 TORIC (HEFILCON A) HYDROPHILIC CONTACT
FDA 510(k)
FDA Class 2
·Ophthalmic
NANOKNIFE SYSTEM
FDA Adverse Event
Injury
·ANGIODYNAMICS·Product code OAB·June 9, 2015
PRECISION SPECTRA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 23, 2022
SYNFRAME GUIDE ROD
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code LXH·April 22, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code MDS·April 18, 2011
BD PARADIGM LINK GLUCOSE MONITOR
FDA Adverse Event
Malfunction
·NOVA BIOMEDICAL CORPORATION·Product code NBW·July 3, 2008
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012