8 results
·
17ms
·
Sources: EU EUDAMED, US FDA
TOOTHBRUSH, REACH
FDA 510(k)
FDA Class 1
·Dental
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515200425·Cobb Elevator, 14", hollow hndl, 1" (25mm) wide
SYSTEM 5 - SEMI-AUTOMATED CLIN. ANALY
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ESTECH PERCUTANEOUS INSERTION DILATOR KIT
FDA 510(k)
FDA Class 2
·Cardiovascular
ACCU-CHEK ® MOBILE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·April 24, 2014
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·October 3, 2012
COLLEAGUE PUMP CE ENGLISH VERSION
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 27, 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