13 results · 20ms · Sources: EU EUDAMED, 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