8 results
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18ms
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Sources: EU EUDAMED, US FDA
STOCKINGS, RVS TM
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
REVOLIX DUO LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Automatic Blood Pressure Monitor Model LD-518 & LD-537
FDA 510(k)
FDA Class 2
·Cardiovascular
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·June 12, 2007
CVC KIT: 3-LUMEN 5.5 FR X 30 CM
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code DQO·February 18, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 3, 2012
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
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