12 results
·
21ms
·
Sources: EU EUDAMED, US FDA
RHEUMANOSTICON R
FDA 510(k)
FDA Class 2
·Immunology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517810076·Interlock II, 14x17x14mm 10°
Salem Sump
FDA UDI
Cardinal Health 200, LLC·10192253010169·Dual Lumen Stomach Tube Multi-functional Port
Salem Sump
FDA UDI
Cardinal Health, Inc.·10884521004443·Dual Lumen Stomach Tube,Multi-functional Port
BIOCORE II TC
FDA UDI
HISTO S.A.·G635771410·Biopsy Needles Biocore II TC
Performa®
FDA UDI
Merit Medical Systems, Inc.·00884450000380·
ePatch
FDA 510(k)
FDA Class 2
·Cardiovascular
ARGEN PEARL BRAND ZIRCONIA
FDA 510(k)
FDA Class 2
·Dental
ENERGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·April 24, 2014
HEARTSTART MRX -EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·September 27, 2012
CONTAK RENEWAL
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·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