10 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ORTHOCAD SOFTWARE OPTION
FDA 510(k)
FDA Class 2
·Radiology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517564528·CoRoent Ant TLIF PEEK, 12x10x28mm 8°
OP Kopfhalter LUCY Upgrade Set Philips
FDA UDI
Noras MRI products GmbH·04251269205835·The NORAS OR Head Holder LUCY is used for intra...
PADPRO, MODEL 2603
FDA 510(k)
FDA Class 3
·Cardiovascular
NEOMED ENTERAL ONLY EXTENSION SET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HEMOCONCENTRATOR BC 20 PLUS
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code KDI·April 1, 2016
SET, I.V. FLUID TRANSFER
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LESSINES·Product code LHI·May 20, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 26, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 10, 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