Company ยท US
Genadyne Biotechnologies, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2008 to 2026. Name variants (Inc, Corp, punctuation) are merged.
21510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 12, 2026 | K253429 | Genadyne ASTRA NPWT Genadyne Biotechnologies, Inc. | OMP |
| Dec 31, 2024 | K243225 | Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes M); Nasal Pillow Mask - Large ( Genadyne Biotechnologies, Inc. | BZD |
| Dec 23, 2024 | K233614 | Genadyne DUO NPWT Genadyne Biotechnologies, Inc. | OMP |
| Jun 12, 2023 | K221888 | Genadyne Hybrid Foam Dressings Genadyne Biotechnologies, Inc. | OMP |
| Dec 14, 2022 | K221891 | UNO Negative Pressure Wound Therapy System Genadyne Biotechnologies, Inc. | OMP |
| Jun 1, 2022 | K210107 | Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System Genadyne Biotechnologies, Inc. | OMP |
| Jan 15, 2020 | K190028 | UNO 30 Genadyne Biotechnologies | OMP |
| Sep 27, 2019 | K182722 | XLR8 Abdominal Wound Dressing Kit Genadyne Biotechnologies | OMP |
| Nov 30, 2018 | K180840 | UNO Negative Pressure Wound Therapy System Genadyne Biotechnologies, Inc. | OMP |
| Apr 6, 2017 | K161599 | UNO Negative Pressure Wound Therapy System Genadyne Biotechnologies, Inc. | OMP |
| Jun 19, 2015 | K143726 | XLR8 PLUS (XLR8+) Genadyne Biotechnologies, Inc. | OMP |
| Apr 30, 2015 | K142646 | XLR8 White Foam Dressing Kit and XLR8 White Foam Small Dressing Kit and Genadyne Biotechnologies, Inc. | OMP |
| Apr 21, 2015 | K143574 | Melodi Prime Breast Pump Genadyne Biotechnologies, Inc. | HGX |
| Mar 26, 2015 | K141961 | GENADYNE SPIRO FOAM DRESSING KIT Genadyne Biotechnologies, Inc. | OMP |
| Sep 19, 2014 | K141437 | XLR8 PLUS (XLR8+) Genadyne Biotechnologies, Inc. | OMP |
| May 10, 2012 | K112856 | LUCINA-MELODI Genadyne Biotechnologies, Inc. | HGX |
| Aug 11, 2011 | K102516 | LUCINA MODEL MELODI Genadyne Biotechnologies, Inc. | HGX |
| Jun 29, 2010 | K092992 | A4-XLR8 FOAM DRESSING Genadyne Biotechnologies, Inc. | OMP |
| Apr 29, 2009 | K090638 | GENADYNE A4-XLR8 WOUND VACUUM SYSTEM Genadyne Biotechnologies, Inc. | OMP |
| Dec 18, 2008 | K082676 | GENADYNE A4 WOUND VACUUM SYSTEM Genadyne Biotechnologies, Inc. | OMP |
| Jul 30, 2008 | K080745 | GENADYNE A4 POWERED SUCTION PUMP Genadyne Biotechnologies, Inc. | BTA |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||