12 results
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20ms
·
Sources: EU EUDAMED, US FDA
COOL.CLICK 2
FDA 510(k)
FDA Class 2
·General Hospital
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496060819·POWER UNISEX, SIZE M, BLU TONIC, ANATOMIC COMPR...
INRATIO
FDA Adverse Event
Malfunction
·HEMOSENSE, INC.·Product code GJS·April 30, 2007
PHILIPS CT SECURA MV
FDA 510(k)
FDA Class 2
·Radiology
3CC NMT SAFETY SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
INRATIO
FDA Adverse Event
Malfunction
·HEMOSENSE, INC.·Product code JPA·June 15, 2007
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·January 21, 2026
AROX 53-BP
FDA Adverse Event
BIOTRONIK SE & CO. KG·Product code DTB·April 16, 2013
STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·March 11, 2011
ORTHO PROVUE
FDA Adverse Event
Malfunction
·MICRO TYPING SYSTEMS, INC.·Product code KSZ·June 12, 2008
Contour¿ next GEN Blood Glucose Monitoring System
FDA Enforcement
Class II
·Ongoing·Ascensia Diabetes Care US, Inc.·July 26, 2023
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