Genadyne Biotechnologies, Inc. - FDA 510(k) Cleared Devices

Cleared Mar 12, 2026

Genadyne ASTRA NPWT

K253429 · OMP

General & Plastic Surgery · 162d

Cleared Dec 23, 2024

Genadyne DUO NPWT

K233614 · OMP

General & Plastic Surgery · 406d

Cleared Jun 12, 2023

Genadyne Hybrid Foam Dressings

K221888 · OMP

General & Plastic Surgery · 348d

Cleared Dec 14, 2022

UNO Negative Pressure Wound Therapy System

K221891 · OMP

General & Plastic Surgery · 168d

Cleared Jun 01, 2022

Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System

K210107 · OMP

General & Plastic Surgery · 502d

Cleared Nov 30, 2018

UNO Negative Pressure Wound Therapy System

K180840 · OMP

General & Plastic Surgery · 245d

Cleared Apr 06, 2017

UNO Negative Pressure Wound Therapy System

K161599 · OMP

General & Plastic Surgery · 301d

Cleared Jun 19, 2015

XLR8 PLUS (XLR8+)

K143726 · OMP

General & Plastic Surgery · 172d

Cleared Apr 30, 2015

XLR8 White Foam Dressing Kit and XLR8 White Foam Small Dressing Kit and

K142646 · OMP

General & Plastic Surgery · 225d

Cleared Mar 26, 2015

GENADYNE SPIRO FOAM DRESSING KIT

K141961 · OMP

General & Plastic Surgery · 251d

Cleared Sep 19, 2014

XLR8 PLUS (XLR8+)

K141437 · OMP

General & Plastic Surgery · 112d

Cleared Jun 29, 2010

A4-XLR8 FOAM DRESSING

K092992 · OMP

General & Plastic Surgery · 274d

Cleared Apr 29, 2009

GENADYNE A4-XLR8 WOUND VACUUM SYSTEM

K090638 · OMP

General & Plastic Surgery · 50d

Cleared Dec 18, 2008

GENADYNE A4 WOUND VACUUM SYSTEM

K082676 · OMP

General & Plastic Surgery · 94d

Cleared Jul 30, 2008

GENADYNE A4 POWERED SUCTION PUMP

K080745 · BTA

General & Plastic Surgery · 135d