13 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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GELATO PROPHYLAXIS PASTE
FDA 510(k)
FDA Class 1
·Dental
SlimLine®
FDA UDI
ZIMMER SPINE, INC.·00889024404205·
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306836152·Bowman Lacrimal Duct Probe, 1.7/1.8mm, 7-8
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710420420480·Anterio Lateral Closing Wedge Osteotomy Guide, ...
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710410420480·Anterior Closing Wedge Osteotomy Guide, 42mm x ...
JBC OPAQUE AND GLITTER
FDA 510(k)
FDA Class 2
·Dental
POWDER FREE NEOPRENE EXAMINATION GLOVES, NON STERILE
FDA 510(k)
FDA Class 1
·General Hospital
GRAFTON PLUS¿ DBM
FDA Adverse Event
Malfunction
·Product code NUN·August 28, 2020
GRAFTON PLUS¿ DBM
FDA Adverse Event
Malfunction
·Product code NUN·August 28, 2020
2520274-2013-01884
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·April 9, 2013
ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL COMPONENT
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code MIH·March 29, 2011
VITALITY 2 VR
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018