9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Rapid ASPECTS (v3)
FDA 510(k)
FDA Class 2
·Radiology
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112915·CORNEAL TREPHINE BLADE7.5MM
RANDOX CSF CONTROLS LEVELS 2 AND 3
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ACCUFIX RADIOLUCENT PELVIS AND BELLY BOARDS, ACCUFIX CANTILEVER HEAD BOARD WITH SHOULDER DEPRESSION, ACCUFIX RADIOLUCENT
FDA 510(k)
FDA Class 2
·Radiology
LOCKING SCREW, FULLY THREADED 4X28 MM
FDA Adverse Event
Injury
·STRYKER TRAUMA KIEL·Product code HWC·January 4, 2007
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 21, 2025
UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code GKZ·September 2, 2011
ONE TOUCH ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·November 4, 2008
LINOX TD 65/18
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code NVY·July 17, 2013