12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ANESTHESIA CONDUCTION NEEDLES
FDA 510(k)
FDA Class 2
·Anesthesiology
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450193525·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450193433·
Tiche PTA Balloon Dilatation Catheter
FDA UDI
BrosMed Medical Co.,Ltd.·06958481476736·
BD PARIDIGM LINK BLOOD GLUCOSE MONITOR
FDA Adverse Event
Other
·BECTON DICKINSON·Product code NBW·June 23, 2005
AXSOS LOCKED PLATING SYSTEM LINE EXTENSION OF 5MM LOCKING INSERTS
FDA 510(k)
FDA Class 2
·Orthopedic
CHAD THERAPEUTICS OXYPENUMATIC CYPRESS MODEL 511
FDA 510(k)
FDA Class 2
·Anesthesiology
THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
FDA Adverse Event
Injury
·BIOSENSE WEBSTER INC·Product code LPB·June 6, 2018
PULSE GEN MODEL UNK
FDA Adverse Event
Injury
·CYBERONICS·Product code LYJ·May 20, 2013
OT VERIO PRO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 26, 2014
PRIME ZOOM STRETCHER, 30"LITTER
FDA Adverse Event
Injury
·STRYKER MEDICAL·Product code INK·June 5, 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