9 results
·
36ms
·
Sources: EU EUDAMED, US FDA
ACON TRI-FECT DRUG SCREEN TEST DEVICE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
CLINICSELECT Blue X-ray Film
FDA UDI
CARESTREAM HEALTH, INC.·40889976041747·CS BLUE X-RAY FILM 35X43-14X17 100SH
(MULTIPLE LABELS) POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: YELLOW
FDA 510(k)
FDA Class 1
·General Hospital
ULTIMA SMARTBELT, MODEL 0560
FDA 510(k)
FDA Class 2
·Anesthesiology
2520274-2013-01870
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·April 8, 2013
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Injury
·ANIMAS CORP.·Product code LZG·March 29, 2011
VITALITY DS VR
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018
Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018