Medical Device Manufacturer · US , Hicksville , NY

Genadyne Biotechnologies, Inc.

19 submissions · 19 cleared · Since 2008
19
Total
19
Cleared
0
Denied

Genadyne Biotechnologies, Inc. — FDA 510(k) Submissions

Genadyne Biotechnologies, Inc. has submitted 19 FDA 510(k) premarket notifications since 2008, of which 19 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Negative Pressure Wound Therapy Powered Suction Pump, Pump, Breast, Powered, Ventilator, Non-continuous (respirator), Pump, Portable, Aspiration (manual Or Powered) . Use the specialty filter in the sidebar to narrow results.

19 devices
1–19 of 19
Genadyne ASTRA NPWT
K253429 · OMP Negative Pressure Wound... · General & Plastic Surgery
Mar 2026 162d
Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes M); Nasal Pillow Mask - Large (NNPM-03/ Nefes L)
K243225 · BZD Ventilator,... · Anesthesiology
Dec 2024 84d
Genadyne DUO NPWT
K233614 · OMP Negative Pressure Wound... · General & Plastic Surgery
Dec 2024 406d
Genadyne Hybrid Foam Dressings
K221888 · OMP Negative Pressure Wound... · General & Plastic Surgery
Jun 2023 348d
UNO Negative Pressure Wound Therapy System
K221891 · OMP Negative Pressure Wound... · General & Plastic Surgery
Dec 2022 168d
Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System
K210107 · OMP Negative Pressure Wound... · General & Plastic Surgery
Jun 2022 502d
UNO Negative Pressure Wound Therapy System
K180840 · OMP Negative Pressure Wound... · General & Plastic Surgery
Nov 2018 245d
UNO Negative Pressure Wound Therapy System
K161599 · OMP Negative Pressure Wound... · General & Plastic Surgery
Apr 2017 301d
XLR8 PLUS (XLR8+)
K143726 · OMP Negative Pressure Wound... · General & Plastic Surgery
Jun 2015 172d
XLR8 White Foam Dressing Kit and XLR8 White Foam Small Dressing Kit and
K142646 · OMP Negative Pressure Wound... · General & Plastic Surgery
Apr 2015 225d
Melodi Prime Breast Pump
K143574 · HGX Pump, Breast, Powered · Obstetrics & Gynecology
Apr 2015 125d
GENADYNE SPIRO FOAM DRESSING KIT
K141961 · OMP Negative Pressure Wound... · General & Plastic Surgery
Mar 2015 251d
XLR8 PLUS (XLR8+)
K141437 · OMP Negative Pressure Wound... · General & Plastic Surgery
Sep 2014 112d
LUCINA-MELODI
K112856 · HGX Pump, Breast, Powered · Obstetrics & Gynecology
May 2012 223d
LUCINA MODEL MELODI
K102516 · HGX Pump, Breast, Powered · Obstetrics & Gynecology
Aug 2011 343d
A4-XLR8 FOAM DRESSING
K092992 · OMP Negative Pressure Wound... · General & Plastic Surgery
Jun 2010 274d
GENADYNE A4-XLR8 WOUND VACUUM SYSTEM
K090638 · OMP Negative Pressure Wound... · General & Plastic Surgery
Apr 2009 50d
GENADYNE A4 WOUND VACUUM SYSTEM
K082676 · OMP Negative Pressure Wound... · General & Plastic Surgery
Dec 2008 94d
GENADYNE A4 POWERED SUCTION PUMP
K080745 · BTA Pump, Portable,... · General & Plastic Surgery
Jul 2008 135d
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