12 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DELTAMAXX 18 MICROCOIL SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
ArgenZ HT+ 100x10
FDA UDI
ARGEN CORPORATION, THE·D818120274·Dental porcelain/ceramic restoration kit
JOBST soSoft
FDA UDI
BSN MEDICAL, INC.·00035664007393·SOSOFT 8-15 MM HG KNEE HIGH RIB EXTRA LARGE BLA...
MIAR (MINIMALLY INVASIVE AORTIC ROOT) CANNULA WITH FLOW-GUARD, MODELS 11012L AND 11014L
FDA 510(k)
FDA Class 2
·Cardiovascular
WMT MODULAR ULNAR HEAD IMPLANT
FDA 510(k)
FDA Class 2
·Orthopedic
BD SYRINGE 20ML LL TIP CONV PAK
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMF·November 12, 2024
GOLDEN COMFORTER
FDA Adverse Event
Malfunction
·GOLDEN TECHNOLOGIES, INC.·Product code INO·October 3, 2012
BD SYRINGE 20ML LL TIP CONV PAK
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMF·September 30, 2024
1.5MM LACTOSORB,100X100MM PNL
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code HRS·May 20, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 26, 2014
RADIAL ARTERY PRESSURE MONITORING SET
FDA Adverse Event
Injury
·COOK INC.·Product code DQY·June 1, 2011
Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format) Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.) Track interproximal decay progression over time Patient education tool
FDA Enforcement
Class II
·Terminated·GA Industries·May 6, 2015