24 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NuVasive Thoracolumbar Plates
FDA 510(k)
FDA Class 2
·Orthopedic
MODIFIED/SPECIAL INSTRUMENT, TURON GLENOID REAMER, REAM AND RUN, Catalog Numbers: REF S-200956 - 5mm PIN, SIZE 46 REF S-200957 - 5mm PIN, SIZE 50 REF S-200958 - 5mm PIN, SIZE 58
FDA Enforcement
Class II
·Terminated·Encore Medical, Lp·September 6, 2017
MODIFIED/SPECIAL INSTRUMENT, TURON GLENOID REAMER, REAM AND RUN, Catalog Numbers: REF S-200956 - 5mm PIN, SIZE 46 REF S-200957 - 5mm PIN, SIZE 50 REF S-200958 - 5mm PIN, SIZE 58
FDA Recall
Terminated
·Product code HTO·August 4, 2017
VIVOSONIC DIANOSTIC ULTRASOUND IMAGING COUPLING MEDIA
FDA 510(k)
FDA Class 2
·Radiology
MODIFICATION TO SCIMED 6F IMPULSE ANGIOGRAPHIC CATHATERS
FDA 510(k)
FDA Class 2
·Cardiovascular
QUICKSET INFUSION SET
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code FPA·July 7, 2009
OPHTHALMIC FEMTOSECOND LASER
FDA Adverse Event
Malfunction
·AMO MANUFACTURING USA, LLC·Product code OOE·February 9, 2021
QUICK SET PARADIGM
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·November 2, 2009
CORE IMPACTION DRILL
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code DZJ·July 1, 2011
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·September 17, 2014
DERMABOND
FDA Adverse Event
Injury
·ETHICON INC.·Product code MPN·July 2, 2013
CATALYS SYSTEM
FDA Adverse Event
Malfunction
·AMO MANUFACTURING USA, LLC·Product code OOE·January 11, 2021
CATALYS SYSTEM
FDA Adverse Event
Malfunction
·AMO MANUFACTURING USA, LLC·Product code OOE·January 11, 2021
CATALYS SYSTEM
FDA Adverse Event
Malfunction
·AMO MANUFACTURING USA, LLC·Product code OOE·March 5, 2021
CATALYS SYSTEM
FDA Adverse Event
Malfunction
·AMO MANUFACTURING USA, LLC·Product code OOE·March 5, 2021
CATALYS SYSTEM
FDA Adverse Event
Malfunction
·AMO MANUFACTURING USA, LLC·Product code OOE·February 16, 2021
COREVALVE SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC CORONARY AND STRUCTURAL HEART·Product code NPT·February 1, 2017
CATALYS PRECISION LASER SYSTEM
FDA Adverse Event
Malfunction
·AMO MANUFACTURING USA, LLC·Product code OOE·February 8, 2021
CATALYS SYSTEM
FDA Adverse Event
Malfunction
·AMO MANUFACTURING USA, LLC·Product code OOE·January 19, 2021
CATALYS SYSTEM
FDA Adverse Event
Malfunction
·AMO MANUFACTURING USA, LLC·Product code OOE·January 19, 2021