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Genadyne Biotechnologies, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
21
Inspections
5
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K253429Genadyne ASTRA NPWTMarch 12, 2026
K243225Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes M); Nasal PDecember 31, 2024
K233614Genadyne DUO NPWTDecember 23, 2024
K221888Genadyne Hybrid Foam DressingsJune 12, 2023
K221891UNO Negative Pressure Wound Therapy SystemDecember 14, 2022
K210107Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy SystemJune 1, 2022
K190028UNO 30January 15, 2020
K182722XLR8 Abdominal Wound Dressing KitSeptember 27, 2019
K180840UNO Negative Pressure Wound Therapy SystemNovember 30, 2018
K161599UNO Negative Pressure Wound Therapy SystemApril 6, 2017
K143726XLR8 PLUS (XLR8+)June 19, 2015
K142646XLR8 White Foam Dressing Kit and XLR8 White Foam Small Dressing Kit andApril 30, 2015
K143574Melodi Prime Breast PumpApril 21, 2015
K141961GENADYNE SPIRO FOAM DRESSING KITMarch 26, 2015
K141437XLR8 PLUS (XLR8+)September 19, 2014
K112856LUCINA-MELODIMay 10, 2012
K102516LUCINA MODEL MELODIAugust 11, 2011
K092992A4-XLR8 FOAM DRESSINGJune 29, 2010
K090638GENADYNE A4-XLR8 WOUND VACUUM SYSTEMApril 29, 2009
K082676GENADYNE A4 WOUND VACUUM SYSTEMDecember 18, 2008