Edwards Lifesciences, LLC - FDA 510(k) Cleared Devices
Recent clearances: HemoSphere Nano Monitor (HSNANO1), Edwards MC3 Tricuspid annuloplasty ring (4900), Carpentier-Edwards Physio Annuloplasty Ring (4450)
135
Total
129
Cleared
1
Denied
FDA 510(k) Regulatory Record - Edwards Lifesciences, LLC General Hospital ✕
3 devices
Cleared
May 18, 2012
MULTI-MED CENTRAL VENOUS CATHETERS (CVCS), WITH AND WITHOUT HEPARIN VANTEX...
General Hospital
168d
Cleared
Oct 13, 2009
MULTI-MED CENTRAL VENOUS CATHETERS, MODELS: M3720HKIC, M4820HKIC
General Hospital
125d
Cleared
Dec 30, 2003
EDWARDS LIFESCIENCES VANTEX CENTRAL VENOUS CATHETERS WITH THERMISTOR
General Hospital
84d