8 results
·
27ms
·
Sources: EU EUDAMED, US FDA
INSTRUMENTED SYSTEM FOR URINALYSIS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Ceramill® Liquid
FDA UDI
Amann Girrbach AG·E4947604721·
PREMISE FLOWABLE
FDA 510(k)
FDA Class 2
·Dental
Hidrocor, Hidrocharme, and Natural Colors
FDA 510(k)
FDA Class 2
·Ophthalmic
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 21, 2014
GYNECARE MORCELLEX* TISSUE MORCELLATOR
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code HET·September 26, 2012
ADVANCED CONTROL BASE
FDA Adverse Event
Other
·MIZUHO ORTHOPEDIC SYSTEMS, INC.·Product code GDC·July 14, 2010
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