24 results · 23ms · Sources: EU EUDAMED, 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