10 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MTS KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Gentle Threads
FDA UDI
Biomet Orthopedics, LLC·00880304004047·
Sklar®
FDA UDI
SKLAR CORPORATION·10649111122149·RECAMIER CURETTE SH 12.5" #2
MEDISENSE PEN 2/COMPANION 2 BLOOD GLUCOSE SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SHEPPERD SHELTER TUBE COMPLETE & DRILL
FDA 510(k)
FDA Class 2
·Orthopedic
OMNIPOD POD
FDA Adverse Event
Injury
·INSULET·Product code LZG·March 4, 2014
CONSERVE(R) PLUS CUP
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code KWA·January 9, 2013
E SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·November 12, 2010
TELIGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·July 1, 2014
Monoject Standard Hypodermic Needle, 16 G x 1-1/2" Item code:8881200045
FDA Enforcement
Class II
·Completed·Cardinal Health 200, LLC·July 31, 2019