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Data / Medical devices / United States / Genadyne Biotechnologies, Inc.

Genadyne Biotechnologies, Inc.: FDA-registered device maker in Hicksville, NY, United States, 16 510(k) clearances

Genadyne Biotechnologies, Inc. is registered with the FDA (registration 2435947) in Hicksville, NY, United States. It lists 13 device types. The FDA files 16 510(k) clearances under its listings, the newest dated March 12, 2026. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Genadyne Biotechnologies, Inc.
FDA registration number
2435947
FEI number
1000137514
Address
16 Midland Ave, Hicksville, NY, United States, 11801
Owner or operator
GENADYNE BIOTECHNOLOGIES, INC. (9006819)
Roles
Manufacturer, Manufacturer for export, Specification developer
First device listed
June 27, 1997
Registered through
2026
Brand names listed
ACT ACTIVE CHANNEL TECHNOLGIES, ACTIVE CHANNEL TECHNOLOGIES, Algen, DUO, DX, GENAIR 8000 PLUS SERI, GENTRACK STD, Gena Foam and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, WheelchairKNO1Manufactureraccessdata.fda.gov
Armrest, WheelchairIML1Manufactureraccessdata.fda.gov
Dressing, Wound, Hydrogel Without Drug And/Or BiologicNAE1Specification developeraccessdata.fda.gov
Dressing, Wound, HydrophilicNAC1Manufacturer, Specification developeraccessdata.fda.gov
Dressing, Wound, OcclusiveNAD1Specification developeraccessdata.fda.gov
Mattress, Air Flotation, Alternating PressureFNM2Manufactureraccessdata.fda.gov
Mattress, Flotation Therapy, Non-PoweredIKY1Manufactureraccessdata.fda.gov
Mesh, Surgical, PolymericFTL2Specification developeraccessdata.fda.gov
Negative Pressure Wound Therapy Powered Suction PumpOMP2Manufacturer, Specification developeraccessdata.fda.gov
Pump, Breast, PoweredHGX2Manufactureraccessdata.fda.gov
Pump, Nebulizer, Electrically PoweredJPW1Manufactureraccessdata.fda.gov
Ventilator, Non-Continuous (Respirator)BZD2Specification developeraccessdata.fda.gov
Warmer, Irrigation SolutionLHC1Manufacturer for exportaccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
March 12, 2026K253429Genadyne ASTRA NPWTOMPSubstantially EquivalentGenadyne Biotechnologies, Inc.accessdata.fda.gov
December 31, 2024K243225Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes M); Nasal Pillow Mask - Large (NNPM-03/ Nefes L)BZDSubstantially EquivalentGenadyne Biotechnologies, Inc.accessdata.fda.gov
December 23, 2024K233614Genadyne DUO NPWTOMPSubstantially EquivalentGenadyne Biotechnologies, Inc.accessdata.fda.gov
June 12, 2023K221888Genadyne Hybrid Foam DressingsOMPSubstantially EquivalentGenadyne Biotechnologies, Inc.accessdata.fda.gov
December 14, 2022K221891UNO Negative Pressure Wound Therapy SystemOMPSubstantially EquivalentGenadyne Biotechnologies, Inc.accessdata.fda.gov
June 1, 2022K210107Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy SystemOMPSubstantially EquivalentGenadyne Biotechnologies, Inc.accessdata.fda.gov
January 15, 2020K190028UNO 30OMPSubstantially EquivalentGenadyne Biotechnologiesaccessdata.fda.gov
September 27, 2019K182722XLR8 Abdominal Wound Dressing KitOMPSubstantially EquivalentGenadyne Biotechnologiesaccessdata.fda.gov
November 30, 2018K180840UNO Negative Pressure Wound Therapy SystemOMPSubstantially EquivalentGenadyne Biotechnologies, Inc.accessdata.fda.gov
April 6, 2017K161599UNO Negative Pressure Wound Therapy SystemOMPSubstantially EquivalentGenadyne Biotechnologies, Inc.accessdata.fda.gov
June 19, 2015K143726XLR8 PLUS (XLR8+)OMPSubstantially EquivalentGenadyne Biotechnologies, Inc.accessdata.fda.gov
May 10, 2012K112856LUCINA-MELODIHGXSubstantially EquivalentGenadyne Biotechnologies, Inc.accessdata.fda.gov
August 11, 2011K102516LUCINA MODEL MELODIHGXSubstantially EquivalentGenadyne Biotechnologies, Inc.accessdata.fda.gov
June 29, 2010K092992A4-XLR8 FOAM DRESSINGOMPSubstantially EquivalentGenadyne Biotechnologies, Inc.accessdata.fda.gov
April 29, 2009K090638GENADYNE A4-XLR8 WOUND VACUUM SYSTEMOMPSubstantially EquivalentGenadyne Biotechnologies, Inc.accessdata.fda.gov
December 18, 2008K082676GENADYNE A4 WOUND VACUUM SYSTEMOMPSubstantially EquivalentGenadyne Biotechnologies, Inc.accessdata.fda.gov

Compare with other makers

Updated March 12, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.