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Genadyne Biotechnologies, Inc.

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

Total Devices8
Categories2
Latest FDA decision2026-03-12
TypeNumberDevice NameCodeDateActions
510(k) K253429 Genadyne ASTRA NPWTOMP2026-03-12 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)BZD2024-12-31 View
510(k) K233614 Genadyne DUO NPWTOMP2024-12-23 View
510(k) K221888 Genadyne Hybrid Foam DressingsOMP2023-06-12 View
510(k) K221891 UNO Negative Pressure Wound Therapy SystemOMP2022-12-14 View
510(k) K210107 Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy SystemOMP2022-06-01 View
510(k) K180840 UNO Negative Pressure Wound Therapy SystemOMP2018-11-30 View
510(k) K161599 UNO Negative Pressure Wound Therapy SystemOMP2017-04-06 View
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