51 results
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32ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GE LOGIQ I COMAPACT ULTRASOUND, GE LOGIQ E COMPACT ULTRASOUND, GE VIVID E COMPACT ULTRASOUND
FDA 510(k)
FDA Class 2
·Radiology
TWINKY STAR
FDA 510(k)
FDA Class 2
·Dental
DIAMEDIX IS-ANTI-GLIADIN IGA TEST SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
INRATIO
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO INC·Product code GJS·October 26, 2010
INRATIO
FDA Adverse Event
Malfunction
·BIOSITE INCORPORATED·Product code GJS·June 3, 2010
INRATIO
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·July 1, 2011
INRATIO
FDA Adverse Event
Other
·ALERE SAN DIEGO, INC.·Product code GJS·October 26, 2010
PRECISION MONTAGE MRI
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 6, 2022
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·April 23, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·March 31, 2011
ATTAIN OTW
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code LWP·July 10, 2008
INRATIO
FDA Adverse Event
Malfunction
·BIOSITE INCORPORATED·Product code JPA·May 10, 2010
INRATIO
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·June 12, 2012
INRATIO
FDA Adverse Event
Malfunction
·BIOSITE INCORPORATED·Product code GJS·May 10, 2010
INRATIO2 PT MONITORING SYSTEM
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·September 11, 2015
INRATIO2 PT MONITORING SYSTEM
FDA Adverse Event
Injury
·ALERE SAN DIEGO, INC.·Product code GJS·September 14, 2015
INRATIO2 PT MONITORING SYSTEM
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·August 3, 2015
DAILIES TOTAL 1
FDA Adverse Event
CIBA VISION GMBH·Product code MVN·February 8, 2013
INRATIO2 PT MONITORING SYSTEM
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·February 4, 2015
INRATIO2 PT MONITORING SYSTEM
FDA Adverse Event
Injury
·ALERE SAN DIEGO, INC.·Product code GJS·April 11, 2016