8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
STYLETTE, SLICK, CAT. NO. 2000B
FDA 510(k)
FDA Class 1
·Anesthesiology
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515198838·Perio Elev, 20mm rnd edge str bld, shp, 7 1/4"
SonoBook Series Diagnostic Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
ARTHROCARE ENT PLASMA WAND
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ONE TOUCH ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·May 14, 2010
HEARTSTART MRX -EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 6, 2014
SPARC SLING SYSTEM
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·October 1, 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