17 results
·
24ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Osstem Abutment System
FDA 510(k)
FDA Class 2
·Dental
BINAXNOW COVID-19 AG SELF TEST 2CT
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·May 11, 2023
BINAXNOW COVID-19 AG SELF TEST 2CT
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·May 11, 2023
BINAXNOW COVID-19 AG SELF TEST 2CT
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·May 11, 2023
BINAXNOW COVID-19 AG SELF TEST 2CT
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·May 11, 2023
BINAXNOW COVID-19 AG SELF TEST 2CT
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·May 11, 2023
BINAXNOW COVID-19 AG SELF TEST 2CT
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·May 11, 2023
BINAXNOW COVID-19 AG SELF TEST 2CT
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·May 11, 2023
BINAXNOW COVID-19 AG SELF TEST 2CT
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·May 11, 2023
BINAXNOW COVID-19 AG SELF TEST 2CT
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·May 11, 2023
NOVATION LPI PRIME FEMORAL STEM
FDA 510(k)
FDA Class 2
·Orthopedic
THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY
FDA 510(k)
FDA Class 2
·Dental
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 13, 2025
PRISM WARM GEL INSTANT HEAT PACK
FDA Adverse Event
COOPER SURGICAL·Product code IMD·October 31, 2008
ENGEN LABORATORY AUTOMATION SYSTEM
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code JJE·August 24, 2011
GYNECARE TVT RETROPUBIC SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·July 11, 2013
Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018