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Genadyne Biotechnologies, Inc.

FDA 510(k) & PMA Approved Devices — 8 products

Total Devices8
Categories2
Latest Approval2026-03-12
TypeNumberDevice NameCodeDate
510(k) K253429 Genadyne ASTRA NPWT OMP 2026-03-12 View
510(k) 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 2024-12-31 View
510(k) K233614 Genadyne DUO NPWT OMP 2024-12-23 View
510(k) K221888 Genadyne Hybrid Foam Dressings OMP 2023-06-12 View
510(k) K221891 UNO Negative Pressure Wound Therapy System OMP 2022-12-14 View
510(k) K210107 Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System OMP 2022-06-01 View
510(k) K180840 UNO Negative Pressure Wound Therapy System OMP 2018-11-30 View
510(k) K161599 UNO Negative Pressure Wound Therapy System OMP 2017-04-06 View
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