8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IRRIGATION/ASPIRATION NEEDLE
FDA 510(k)
FDA Class 1
·Ophthalmic
BIOCORE II TC
FDA UDI
HISTO S.A.·G635771416·Biopsy Needles Biocore II TC
PYRAMID +4 ANTERIOR LUMBAR SPINE PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
LEAD, HEART, BUTTERFLY CLAMP
FDA 510(k)
FDA Class 3
·Cardiovascular
TELIGEN
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·April 24, 2014
IE33 ULTRASOUND MACHINE
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code IYO·September 13, 2012
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·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