125 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VISIUS WIRELESS COILS, 1.5T/ VISIUS WIRELESS COILS, 3T
FDA 510(k)
FDA Class 2
·Radiology
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K1230010·Rod Holder, Straight, 5.5 mm
LANX SPINAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ST AIA-PACK TESTOSTERONE ASSAY
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CATALYS SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL OPTICS·Product code OOE·March 14, 2016
ENDOWRIST FENESTRATED BIPOLAR FORCEPS
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC.·Product code NAY·March 5, 2024
CATALYS SYSTEM
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code OOE·October 30, 2015
VALIANT
FDA Adverse Event
Death
·MEDTRONIC IRELAND·Product code MIH·May 21, 2013
RESERVOIR 1.8ML
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code FRN·September 26, 2014
ISOLINE
FDA Adverse Event
Injury
·SORIN BIOMEDICA CRM·Product code MRM·September 5, 2008
CATALYS SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL OPTICS·Product code OOE·March 14, 2016
CARDINAL HEALTH
FDA Adverse Event
Malfunction
·JIANGSU CAINA MEDICAL CO., LTD.·Product code FMF·April 12, 2024
CARDINAL HEALTH
FDA Adverse Event
Malfunction
·JIANGSU CAINA MEDICAL CO., LTD.·Product code FMF·April 12, 2024
CARDINAL HEALTH
FDA Adverse Event
Malfunction
·JIANGSU CAINA MEDICAL CO., LTD.·Product code FMF·April 11, 2024
CATALYS SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL OPTICS·Product code OOE·February 11, 2016
CATALYS SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL OPTICS·Product code OOE·February 10, 2016
CATALYS SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL OPTICS·Product code OOE·February 11, 2016
CATALYS SYSTEM
FDA Adverse Event
Injury
·JOHNSON & JOHNSON SURGICAL VISION, INC·Product code OOE·July 13, 2018
CATALYS SYSTEM
FDA Adverse Event
Malfunction
·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code OOE·January 28, 2022
CARDINALHEALTH
FDA Adverse Event
Malfunction
·JIANGSU CAINA MEDICAL CO., LTD.·Product code FMF·April 13, 2024