9 results
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17ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BREMER HALO SYSTEM TITANIUM SKULL PIN
FDA 510(k)
FDA Class 2
·Orthopedic
artegral life
FDA UDI
Merz Dental GmbH·D7091993099·anteriors; shade A3.5; mould CL
QUIDEL HELICOBACTER PYLORI TEST
FDA 510(k)
FDA Class 1
·Microbiology
Anatomical Shoulder System
FDA 510(k)
FDA Class 2
·Orthopedic
Proteus XR/a (SlOK : K993090)
FDA Recall
Open, Classified
·GE Healthcare, LLC·Product code KPR·August 9, 2019
HEMA 4 BRANCH 22MM PLATINUM GRAFT
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code DSY·March 1, 2013
RENAL - DISPOSABLE
FDA Adverse Event
Injury
·Product code KDJ·February 16, 2011
CARELINK
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code KRG·August 8, 2014
Proteus XR/a (SlOK : K993090)
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·October 2, 2019