8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ACE UNIVERSAL TONG
FDA 510(k)
FDA Class 2
·Neurology
RHIGENE HEP-ANA TEST SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
ENDOCAPSULE SOFTWARE 10; ENDOCAPSULE SOFTWARE 10 LIGHT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SILVER SOAKER 5IN (12.5CM): 40ML, DUAL 2+2 ML/HR
FDA Adverse Event
Injury
·I-FLOW LLC·Product code BSO·June 20, 2013
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Injury
·TANDEM DIABETES·Product code LZG·May 19, 2014
RESTORE ULTRA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·November 21, 2012
PROSTIVA
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code KNS·September 3, 2010
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 135 MM, Silicone, Sterile, Item 431191.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020