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Genadyne Biotechnologies, Inc.

19 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
Genadyne ASTRA NPWT (K253429)Genadyne Biotechnologies, Inc.2026-03-12
Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes M); Nasal Pillow Mask - Large (NNPM-03/ Nefes L) (K243225)Genadyne Biotechnologies, Inc.2024-12-31
Genadyne DUO NPWT (K233614)Genadyne Biotechnologies, Inc.2024-12-23
Genadyne Hybrid Foam Dressings (K221888)Genadyne Biotechnologies, Inc.2023-06-12
UNO Negative Pressure Wound Therapy System (K221891)Genadyne Biotechnologies, Inc.2022-12-14
Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System (K210107)Genadyne Biotechnologies, Inc.2022-06-01
UNO Negative Pressure Wound Therapy System (K180840)Genadyne Biotechnologies, Inc.2018-11-30
UNO Negative Pressure Wound Therapy System (K161599)Genadyne Biotechnologies, Inc.2017-04-06
XLR8 PLUS (XLR8+) (K143726)Genadyne Biotechnologies, Inc.2015-06-19
XLR8 White Foam Dressing Kit and XLR8 White Foam Small Dressing Kit and (K142646)Genadyne Biotechnologies, Inc.2015-04-30
Melodi Prime Breast Pump (K143574)Genadyne Biotechnologies, Inc.2015-04-21
GENADYNE SPIRO FOAM DRESSING KIT (K141961)Genadyne Biotechnologies, Inc.2015-03-26
XLR8 PLUS (XLR8+) (K141437)Genadyne Biotechnologies, Inc.2014-09-19
LUCINA-MELODI (K112856)Genadyne Biotechnologies, Inc.2012-05-10
LUCINA MODEL MELODI (K102516)Genadyne Biotechnologies, Inc.2011-08-11
A4-XLR8 FOAM DRESSING (K092992)Genadyne Biotechnologies, Inc.2010-06-29
GENADYNE A4-XLR8 WOUND VACUUM SYSTEM (K090638)Genadyne Biotechnologies, Inc.2009-04-29
GENADYNE A4 WOUND VACUUM SYSTEM (K082676)Genadyne Biotechnologies, Inc.2008-12-18
GENADYNE A4 POWERED SUCTION PUMP (K080745)Genadyne Biotechnologies, Inc.2008-07-30

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Every clearance here is in the API, with alerts when new ones post.