Smith & Nephew Medical, Ltd. - FDA 510(k) Cleared Devices
Recent clearances: RENASYS DYNAFLOW Kit (66807741), RENASYS EDGE (66803126), RENASYS WOUND+ Dressing Kit with AIRLOCK Technology
9
Total
9
Cleared
0
Denied
FDA 510(k) Regulatory Record - Smith & Nephew Medical, Ltd. General & Plastic Surgery ✕
9 devices
Cleared
Sep 11, 2026
RENASYS DYNAFLOW Kit (66807741)
General & Plastic Surgery
141d
Cleared
May 27, 2026
RENASYS EDGE (66803126)
General & Plastic Surgery
89d
Cleared
Sep 11, 2025
RENASYS WOUND+ Dressing Kit with AIRLOCK Technology
General & Plastic Surgery
90d
Cleared
Feb 18, 2025
RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port
General & Plastic Surgery
91d
Cleared
May 24, 2024
Renasys Edge
General & Plastic Surgery
329d
Cleared
Dec 20, 2019
IODOSORB
General & Plastic Surgery
274d
Cleared
Dec 20, 2019
IODOFLEX
General & Plastic Surgery
270d
Cleared
Aug 04, 2016
RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH Canisters,...
General & Plastic Surgery
273d
Cleared
Jan 28, 2016
PICO Single Use Negative Pressure Wound Therapy System
General & Plastic Surgery
245d