8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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UNIVERSAL GENERAL USE KIT #7-510-16
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PAQ.144X75X400*31*BOSCH-FK.MN
FDA UDI
AB MEDICA GROUP, S.A.·08428763009061·
ABBOTT LIFECARE 5000 PUMP
FDA 510(k)
FDA Class 2
·General Hospital
BATTERY-POWERED TOOTHBRUSH
FDA 510(k)
FDA Class 1
·Dental
ACRYSOF
FDA Adverse Event
Other
·ALCON RESEARCH, LTD./HUNTINGTON·Product code HQL·November 19, 2010
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·January 14, 2013
QUICKFLEX MICRO LV LEAD
FDA Adverse Event
Death
·ST. JUDE MEDICAL, INC., CRMD·Product code OJX·July 3, 2014
Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024