7 results
·
27ms
·
Sources: EU EUDAMED, US FDA
DISPOSABLE COAXIAL BIPOLAR PEN P/N 00150
FDA 510(k)
FDA Class 2
·Neurology
Responsive Arthroscopy Suture Anchor System
FDA 510(k)
FDA Class 2
·Orthopedic
19-INCH (48CM) 1.3M COLOR LCD MONITOR CDL1909A
FDA 510(k)
FDA Class 2
·Radiology
FREESTYLE
FDA Adverse Event
Malfunction
·Product code LFR·June 18, 2014
RUSCH SLICK SET UNCUFFED ENDOTRACHEAL TUBE 3MM
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code BTR·October 5, 2010
MINIARC SLING SYSTEM
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·December 13, 2012
SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·April 20, 2016