Genadyne Biotechnologies, Inc. - FDA 510(k) Cleared Devices
19
Total
19
Cleared
0
Denied
15 devices
Cleared
Mar 12, 2026
Genadyne ASTRA NPWT
General & Plastic Surgery
162d
Cleared
Dec 23, 2024
Genadyne DUO NPWT
General & Plastic Surgery
406d
Cleared
Jun 12, 2023
Genadyne Hybrid Foam Dressings
General & Plastic Surgery
348d
Cleared
Dec 14, 2022
UNO Negative Pressure Wound Therapy System
General & Plastic Surgery
168d
Cleared
Jun 01, 2022
Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System
General & Plastic Surgery
502d
Cleared
Nov 30, 2018
UNO Negative Pressure Wound Therapy System
General & Plastic Surgery
245d
Cleared
Apr 06, 2017
UNO Negative Pressure Wound Therapy System
General & Plastic Surgery
301d
Cleared
Jun 19, 2015
XLR8 PLUS (XLR8+)
General & Plastic Surgery
172d
Cleared
Apr 30, 2015
XLR8 White Foam Dressing Kit and XLR8 White Foam Small Dressing Kit and
General & Plastic Surgery
225d
Cleared
Mar 26, 2015
GENADYNE SPIRO FOAM DRESSING KIT
General & Plastic Surgery
251d
Cleared
Sep 19, 2014
XLR8 PLUS (XLR8+)
General & Plastic Surgery
112d
Cleared
Jun 29, 2010
A4-XLR8 FOAM DRESSING
General & Plastic Surgery
274d