7 results
·
25ms
·
Sources: EU EUDAMED, US FDA
HEMATOLOGY SLIDE STAINER
FDA 510(k)
FDA Class 1
·Pathology
POWERASSET RADIOFREQUENCY GUIDWIRE, MODEL VARIOUS
FDA 510(k)
FDA Class 2
·Cardiovascular
leva Pelvic Floor Trainer
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 3, 2014
TELIGEN
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 10, 2012
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·May 19, 2015
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