FDA 510(k) Applications Submitted by GENADYNE BIOTECHNOLOGIES, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K180840 |
03/30/2018 |
UNO Negative Pressure Wound Therapy System |
Genadyne Biotechnologies, Inc. |
| K233614 |
11/13/2023 |
Genadyne DUO NPWT |
Genadyne Biotechnologies, Inc. |
| K141961 |
07/18/2014 |
GENADYNE SPIRO FOAM DRESSING KIT |
GENADYNE BIOTECHNOLOGIES, INC. |
| K141437 |
05/30/2014 |
XLR8 PLUS (XLR8+) |
GENADYNE BIOTECHNOLOGIES, INC. |
| K102516 |
09/02/2010 |
LUCINA MODEL MELODI |
GENADYNE BIOTECHNOLOGIES, INC. |
| K243225 |
10/08/2024 |
Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes M); Nasal Pillow Mask - Large (NNPM-03/ Nefes L) |
Genadyne Biotechnologies, Inc. |
| K161599 |
06/09/2016 |
UNO Negative Pressure Wound Therapy System |
GENADYNE BIOTECHNOLOGIES, INC. |
| K143574 |
12/17/2014 |
Melodi Prime Breast Pump |
Genadyne Biotechnologies, Inc. |
| K143726 |
12/29/2014 |
XLR8 PLUS (XLR8+) |
GENADYNE BIOTECHNOLOGIES, INC. |
| K090638 |
03/10/2009 |
GENADYNE A4-XLR8 WOUND VACUUM SYSTEM |
GENADYNE BIOTECHNOLOGIES, INC. |
| K082676 |
09/15/2008 |
GENADYNE A4 WOUND VACUUM SYSTEM |
GENADYNE BIOTECHNOLOGIES, INC. |
| K112856 |
09/30/2011 |
LUCINA-MELODI |
GENADYNE BIOTECHNOLOGIES, INC. |
| K092992 |
09/28/2009 |
A4-XLR8 FOAM DRESSING |
GENADYNE BIOTECHNOLOGIES, INC. |
| K080745 |
03/17/2008 |
GENADYNE A4 POWERED SUCTION PUMP |
GENADYNE BIOTECHNOLOGIES, INC. |
| K210107 |
01/15/2021 |
Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System |
Genadyne Biotechnologies, Inc. |
| K221888 |
06/29/2022 |
Genadyne Hybrid Foam Dressings |
Genadyne Biotechnologies, Inc. |
|
|
