9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
MNITROL HEMOTOL. REF. AND CONTROL
FDA 510(k)
FDA Class 2
·Hematology
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515198869·Chandler Elev, 17 x 25mm, 9"
ARGON CONTINUOUS FLUSH DEVICE
FDA 510(k)
FDA Class 2
·Cardiovascular
Dentium NR Line CAD/CAM Abutments
FDA 510(k)
FDA Class 2
·Dental
HYBRID INSERTION HANDLE
FDA Adverse Event
Malfunction
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HSB·April 30, 2020
ONE TOUCH ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·May 14, 2010
AC POWER MODULE
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 6, 2014
COULTER® LH 750 HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code GKZ·October 3, 2012
GE Healthcare, Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV and E-CAiOVX. The Datex-Ohmeda S/5MT Compact Airway Module, E-CAiOVX family is used for monitoring hospital patients respiration, ventilation, and gas exchange status.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·June 25, 2014