11 results
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17ms
·
Sources: EU EUDAMED, US FDA
GCA-9300 NUCLEAR TOMOGRAPHY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
Printed Upper Crown Pack for Herbst UL4
FDA UDI
SPECIALTY APPLIANCES, LLC·D8199015450·
Map-iT
FDA UDI
ACCESS POINT TECHNOLOGIES, INC.·00818083012038·Fixed, 10 electrode, CS, 2mm electrode spacing
Sklar®
FDA UDI
SKLAR CORPORATION·10649111246326·5000 HOOK SCISS 45CM 5MM
Osteotome
FDA UDI
BICON, LLC·00813110026033·4.5mm Osteotome
PIPET CURET
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
DIGITAL RADIOGRAPHY CXDI-60C
FDA 510(k)
FDA Class 2
·Radiology
CONTOUR
FDA Adverse Event
Injury
·BAYER HEALTHCARE LLC·Product code NBW·June 30, 2014
VISIAN ICL (IMPLANTABLE COLLAMER LENS)
FDA Adverse Event
Malfunction
·STAAR SURGICAL CO.·Product code MTA·January 4, 2013
SJM EPIC STENTED PORCINE HEART VALVE
FDA Adverse Event
Injury
·ST JUDE MEDICAL BRASIL LTDA.·Product code LWR·November 12, 2010
Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 7901545, 15mm, 5.5mm dia x 45mm, size: 15mm x 45mm, for spinal fixation.
FDA Recall
Terminated
·Medtronic Sofamor Danek USA Inc·Product code NQP·November 12, 2007