13 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Infrared Ear Thermometer
FDA 510(k)
FDA Class 2
·General Hospital
CYBER TM FAMILY
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ZOLL E SERIES WITH BLUETOOTH DIAL UP NETWORKING
FDA 510(k)
FDA Class 3
·Cardiovascular
TRIFUSE
FDA Adverse Event
Malfunction
·ICU MEDICAL·Product code FMG·October 3, 2017
9" SMALLBORE EXT SET W/CLAVE®, CLAMPS, ROTATING LUER
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FMG·April 5, 2019
QUANTA SYSTEM S.P.A.
FDA Adverse Event
Malfunction
·QUANTA SYSTEM, S.P.A.·Product code GEX·July 10, 2015
PROMOTE PLUS CRT-D
FDA Adverse Event
Death
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·June 20, 2013
NDEHP 2CLV YSTE MICR
FDA Adverse Event
Malfunction
·HOSPIRA, LTD.·Product code FPA·July 7, 2011
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE INC.·Product code LZG·October 14, 2014
SHORELINE ACS, WAVEFORM C
FDA Adverse Event
Injury
·SEASPINE ORTHOPEDICS CORPORATION·Product code OVE·November 12, 2025
SHORELINE ACS, WAVEFORM C
FDA Adverse Event
Injury
·SEASPINE ORTHOPEDICS CORPORATION·Product code OVE·November 12, 2025
SHORELINE ACS, WAVEFORM C
FDA Adverse Event
Injury
·SEASPINE ORTHOPEDICS CORPORATION·Product code OVE·November 12, 2025
9" SMALLBORE EXT SET W/CLAVE®, CLAMPS, ROTATING LUER
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FMG·June 5, 2019