7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SWAN-GANZ FLOW-DIRECTED THERMODILUTION
FDA 510(k)
FDA Class 2
·Cardiovascular
CPS 1.5/2.0/2.5 BIOABSORBABLE FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Dental
7D Surgical System
FDA 510(k)
FDA Class 2
·Neurology
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·January 9, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·October 31, 2012
4 LEAD TUR IRRIGATION SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - AIBONITO·Product code LJH·August 20, 2010
Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·September 30, 2015