12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ACON PPX ONE STEP PROPOXYPHENE TEST STRIP AND ACON PPX STEP PROPOXYPHENE TEST DEVICE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Leksell Stereotactic System
FDA UDI
Elekta Solutions AB·07340201502884·LEKSELL STEREOTACTIC SYSTEM CLAMP - FRAME SUPPORT
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319735497·Cuticle Scissors 3-1/2" (8.8cm), curved blades,...
C & B FORMULA
FDA UDI
AMERICAN TOOTH INDUSTRIES·D772ATI400404450·C & B FORMULA 4 OZ SHADE 45
MEDTRONIC MODEL 7499 EXTENSION
FDA 510(k)
FDA Class 2
·Neurology
PRECISE NITINOL STENT TRANSHEPATIC BILLARY SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
STELLARIS 20G VIT CUTTER 6/BX
FDA Adverse Event
Malfunction
·BAUSCH & LOMB, INC.·Product code HQC·April 3, 2013
CD HORIZON LEGACY SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA·Product code KWP·May 8, 2008
MEDISENSE OPTIUM
FDA Adverse Event
Malfunction
·Product code NBW·April 5, 2011
VITEK® 2 AST-N350
FDA Adverse Event
Malfunction
·BIOMERIEUX, INC.·Product code LON·December 17, 2018
VITEK® 2 AST-N350
FDA Adverse Event
Malfunction
·BIOMERIEUX, INC.·Product code LON·December 17, 2018
Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018