9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814268·GENUMEDI PT SILVER R III
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613061883·Wiener Antrum Rasp, Large, Trocar Tip, 5mm Diam...
TEPHAFLEX MESH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SICAT IMPLANT V1.2
FDA 510(k)
FDA Class 2
·Radiology
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·June 3, 2013
SYNCHRON® SYSTEMS RHEUMATOID FACTOR (RF) REAGENT
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code DHR·June 29, 2011
AUTOCAT2 WAVE
FDA Adverse Event
Death
·ARROW INTL., INC.·Product code DSP·August 29, 2008
IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil.
FDA Enforcement
Class II
·Terminated·Carl Zeiss Meditec AG·December 9, 2015