10 results
·
31ms
·
Sources: EU EUDAMED, US FDA
MODIFICATION TO GE DISCOVERY LS SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
BURAQ SURGICAL CORP.
FDA registration
BURAQ SURGICAL CORP.·18 products·🇵🇰 Pakistan
K042172
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code FPA·September 2, 2022
LEAD BLOCKS
FDA 510(k)
FDA Class 2
·Radiology
DEPUY CONTOUR UNICOMPARTMENTAL KNEE PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
ONQ PAIN RELIEF SYSTEM
FDA Adverse Event
Malfunction
·I-FLOW·Product code MEB·April 1, 2013
JOSTENT GRAFTMASTER
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MAF·April 5, 2011
XACT CAROTID STENT SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR GALWAY·Product code NIM·May 8, 2008
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
Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood flow in a limb to create a bloodless surgical field. Tourniquet cuffs are available in a variety of sizes to accommodate a wide range of limb circumferences.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·November 9, 2016