12 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS
FDA 510(k)
FDA Class 2
·Immunology
ADVIA CHEMISTRY GLUCOSE HEXOKINASE_3 (GLUH_3) REAGENT, MODELS REF 05001429
FDA 510(k)
FDA Class 2
·Clinical Chemistry
XIA TITANIUM SPINAL SYSTEM AND XIA STAINLESS STEEL SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
AESCULAP SURGICAL INSTRUMENTS
FDA Adverse Event
Injury
·CHRISTOPH MIETHKE GMBH & CO. KG·Product code JXG·November 27, 2019
AESCULAP SURGICAL INSTRUMENTS
FDA Adverse Event
Injury
·CHRISTOPH MIETHKE GMBH & CO. KG·Product code JXG·November 27, 2019
Matrixx System
FDA UDI
NEXXT SPINE, LLC·00889929066157·Corpectomy, 16Dx18Wx54H 0°
Matrixx System
FDA UDI
NEXXT SPINE, LLC·00889929066461·Corpectomy, 16Dx18Wx54H 6°
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 11, 2013
BIPOL LEAD MODEL 300
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·July 8, 2011
R SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·July 24, 2014
PROGAV SYS PED.W/SA 15 A.PRECHAMBER
FDA Adverse Event
Injury
·CHRISTOPH MIETHKE GMBH & CO. KG·Product code JXG·April 4, 2019
PROGAV 2.0 SYS PED.W/SA15 A.PRECHAMBER
FDA Adverse Event
Injury
·CHRISTOPH MIETHKE GMBH & CO. KG·Product code JXG·August 6, 2020