Total clearances
7
2020-01-15 → 2026-03-12
Name variants in FDA filings: Genadyne Biotechnologies / Genadyne Biotechnologies, Inc.
Trend
Clearance cadence by quarter
Portfolio
Product codes worked
| Code |
Device name |
Class |
Specialty |
Clearances |
Most recent |
| OMP |
Negative Pressure Wound Therapy Powered Suction Pump |
Class II |
General, Plastic Surgery |
6 |
2026-03-12 |
| BZD |
Ventilator, Non-Continuous (Respirator) |
Class II |
Anesthesiology |
1 |
2024-12-31 |
Filings
All 510(k) clearances (7)
| Date |
K-number |
Device |
Code |
Class |
Specialty |
| 2026-03-12 |
K253429 |
Genadyne ASTRA NPWT |
OMP |
Class II |
General, Plastic Surgery |
| 2024-12-31 |
K243225 |
Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes M); Nasal Pillow Mask - Large (NNPM-03/ Nefes L) |
BZD |
Class II |
Anesthesiology |
| 2024-12-23 |
K233614 |
Genadyne DUO NPWT |
OMP |
Class II |
General, Plastic Surgery |
| 2023-06-12 |
K221888 |
Genadyne Hybrid Foam Dressings |
OMP |
Class II |
General, Plastic Surgery |
| 2022-12-14 |
K221891 |
UNO Negative Pressure Wound Therapy System |
OMP |
Class II |
General, Plastic Surgery |
| 2022-06-01 |
K210107 |
Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System |
OMP |
Class II |
General, Plastic Surgery |
| 2020-01-15 |
K190028 |
UNO 30 |
OMP |
Class II |
General, Plastic Surgery |