Edwards Lifesciences, LLC - FDA 510(k) Cleared Devices
Recent clearances: Respiration Rate algorithm, HemoSphere Nano Monitor (HSNANO1), Edwards MC3 Tricuspid annuloplasty ring (4900)
136
Total
130
Cleared
1
Denied
FDA 510(k) Regulatory Record - Edwards Lifesciences, LLC General & Plastic Surgery ✕
5 devices
Cleared
Feb 10, 2021
FORE-SIGHT ELITE Absolute Tissue Oximeter
General & Plastic Surgery
75d
Cleared
Jun 16, 2015
Edwards Suture Fastening System
General & Plastic Surgery
75d
Cleared
Jan 16, 2015
EDWARDS LIFESCIENCES THRUPORT KNOTTING SYSTEM
General & Plastic Surgery
252d
Cleared
Sep 29, 2004
EDWARDS E360 SURGICAL ABLATION DEVICE
General & Plastic Surgery
93d
Cleared
Feb 27, 2002
LIFESTITCH SUTURING DEVICE
General & Plastic Surgery
86d