Genadyne Biotechnologies, Inc.
Hicksville, NY, US
Genadyne Biotechnologies, Inc. appears in FDA device records in Hicksville, NY. FDA records list 21 510(k) clearances between and , no PMA records and 3 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 21 510(k) clearances for Genadyne Biotechnologies, Inc. between 2008 and 2026. The busiest year on record is 2015, with 4. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2008 | 2 |
| 2009 | 1 |
| 2010 | 1 |
| 2011 | 1 |
| 2012 | 1 |
| 2014 | 1 |
| 2015 | 4 |
| 2017 | 1 |
| 2018 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| 2022 | 2 |
| 2023 | 1 |
| 2024 | 2 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253429 | Genadyne ASTRA NPWT | OMP | Substantially Equivalent | |
| 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 | Substantially Equivalent | |
| K233614 | Genadyne DUO NPWT | OMP | Substantially Equivalent | |
| K221888 | Genadyne Hybrid Foam Dressings | OMP | Substantially Equivalent | |
| K221891 | UNO Negative Pressure Wound Therapy System | OMP | Substantially Equivalent | |
| K210107 | Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System | OMP | Substantially Equivalent | |
| K190028 | UNO 30 | OMP | Substantially Equivalent | |
| K182722 | XLR8 Abdominal Wound Dressing Kit | OMP | Substantially Equivalent | |
| K180840 | UNO Negative Pressure Wound Therapy System | OMP | Substantially Equivalent | |
| K161599 | UNO Negative Pressure Wound Therapy System | OMP | Substantially Equivalent | |
| K143726 | XLR8 PLUS (XLR8+) | OMP | Substantially Equivalent | |
| K142646 | XLR8 White Foam Dressing Kit and XLR8 White Foam Small Dressing Kit and | OMP | Substantially Equivalent | |
| K143574 | Melodi Prime Breast Pump | HGX | Substantially Equivalent | |
| K141961 | GENADYNE SPIRO FOAM DRESSING KIT | OMP | Substantially Equivalent | |
| K141437 | XLR8 PLUS (XLR8+) | OMP | Substantially Equivalent | |
| K112856 | LUCINA-MELODI | HGX | Substantially Equivalent | |
| K102516 | LUCINA MODEL MELODI | HGX | Substantially Equivalent | |
| K092992 | A4-XLR8 FOAM DRESSING | OMP | Substantially Equivalent | |
| K090638 | GENADYNE A4-XLR8 WOUND VACUUM SYSTEM | OMP | Substantially Equivalent | |
| K082676 | GENADYNE A4 WOUND VACUUM SYSTEM | OMP | Substantially Equivalent | |
| K080745 | GENADYNE A4 POWERED SUCTION PUMP | BTA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2435947 | 1000137514 | GENADYNE BIOTECHNOLOGIES, INC. | 16 Midland Ave, Hicksville, NY 11801 US | 2026 | and 3 more, listed in full below |
| 3011582224 | 3011582224 | Genadyne Biotechnologies, Inc. | 519 Johnson Ave, Bohemia, NY 11716 US | 2026 | |
| 3039256597 | 3039256597 | Genadyne Biotechnologies, Inc. | 90 Welles Rd, Mystic, CT 06355 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KNOAccessories, Wheelchair
- IMLArmrest, Wheelchair
- NAEDressing, Wound, Hydrogel Without Drug And/Or Biologic
- NACDressing, Wound, Hydrophilic
- NADDressing, Wound, Occlusive
- FNMMattress, Air Flotation, Alternating Pressure
- IKYMattress, Flotation Therapy, Non-Powered
- FTLMesh, Surgical, Polymeric
- OMPNegative Pressure Wound Therapy Powered Suction Pump
- HGXPump, Breast, Powered
- JPWPump, Nebulizer, Electrically Powered
- BTAPump, Portable, Aspiration (Manual Or Powered)
- BZDVentilator, Non-Continuous (Respirator)
- LHCWarmer, Irrigation Solution
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain