9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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uMR 680
FDA 510(k)
FDA Class 2
·Radiology
AED
FDA UDI
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657006545·Weil Blakesley Forceps, size 01, 90 degree, 3 x...
Sklar®
FDA UDI
SKLAR CORPORATION·10649111190650·BROPHY SULLIVAN CV SH SER 53/4
Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack
FDA 510(k)
FDA Class 2
·Microbiology
LIFEGUARD
FDA 510(k)
FDA Class 2
·Hematology
SYNCHROMED II
FDA Adverse Event
MEDTRONIC NEUROMODULATION·Product code LKK·August 11, 2011
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS INC.·Product code CBK·August 6, 2014
PROGRAMMING SOFTWARE
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·July 12, 2013
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018