13 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CRANIAL REMOLDING ORTHOSIS
FDA 510(k)
FDA Class 2
·Neurology
N LATEX RF KIT
FDA 510(k)
FDA Class 2
·Immunology
ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION
FDA Adverse Event
Injury
·XERIDIEM MEDICAL DEVICES·Product code PIF·April 18, 2018
XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·June 14, 2013
COULTER LH 750 HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code GKZ·July 1, 2011
MANUAL ORTHOPEDIC SURGICAL INSTRUMENT
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC INC.·Product code LXH·September 18, 2008
COOK CELECT PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DTK·December 14, 2020
ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION
FDA Adverse Event
Malfunction
·XERIDIEM MEDICAL DEVICES·Product code PIF·April 25, 2018
ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION
FDA Adverse Event
Malfunction
·XERIDIEM MEDICAL DEVICES·Product code PIF·April 25, 2018
ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION
FDA Adverse Event
Death
·XERIDIEM MEDICAL DEVICES·Product code PIF·April 25, 2018
ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION
FDA Adverse Event
Malfunction
·XERIDIEM MEDICAL DEVICES·Product code PIF·April 26, 2018
AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment.
FDA Enforcement
Class II
·Terminated·Vision Rt Inc·January 14, 2015