7 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Wrist Blood Pressure Monitor (222); Wrist Blood Pressure Monitor (222BT); Wrist Blood Pressure Monitor (W1681BL); Wrist Blood Pressure Monitor (W1681BT); Wrist Blood Pressure Monitor (W1681R)
FDA 510(k)
FDA Class 2
·Cardiovascular
CLINICAL LASETTE P-200
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
THERMEDX FLUID MANAGMENT SYSTEM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
MITRACLIP SYSTEM CLIP DELIVERY SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NKM·November 6, 2014
UNICEL® DXC SYNCHRON ® CHEMISTRY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·September 4, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 18, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025