FDA.reportPublic FDA data

GENADYNE BIOTECHNOLOGIES, INC.

Matched from indexed company URL: Genadyne Biotechnologies

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
24359471000137514GENADYNE BIOTECHNOLOGIES, INC.1N2026-01-0116 Midland Ave Hicksville NY US 11801
30115822243011582224Genadyne Biotechnologies, Inc.1N2026-01-01519 Johnson Ave Bohemia NY US 11716
30392565973039256597Genadyne Biotechnologies, Inc.1Y2026-01-0190 Welles Rd Mystic CT US 06355

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
138581720924953K253429Genadyne ASTRA NPWTOMP2026-03-12
1827541720924953K253429Genadyne ASTRA NPWTOMP2026-03-12
138582062848166K243225Nasal 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
1827542062848166K243225Nasal 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
3421021870686923K233614Genadyne DUO NPWTOMP2024-12-23
1827541977136417K233614Genadyne DUO NPWTOMP2024-12-23
138581977136417K233614Genadyne DUO NPWTOMP2024-12-23
138581751331287K221891UNO Negative Pressure Wound Therapy SystemOMP2022-12-14
1827541751331287K221891UNO Negative Pressure Wound Therapy SystemOMP2022-12-14
3421021491869736K221888Genadyne Hybrid Foam DressingsOMP2023-06-12
138581874371380K221888Genadyne Hybrid Foam DressingsOMP2023-06-12
1827541874371380K221888Genadyne Hybrid Foam DressingsOMP2023-06-12
138581423389213K210107Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy SystemOMP2022-06-01
1827541423389213K210107Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy SystemOMP2022-06-01
3421022012042739K210107Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy SystemOMP2022-06-01
1827542059481645K190028UNO 30OMP2020-01-15
138582059481645K190028UNO 30OMP2020-01-15
3421021818006239K182722XLR8 Abdominal Wound Dressing KitOMP2019-09-27
1827541976527685K182722XLR8 Abdominal Wound Dressing KitOMP2019-09-27
138581976527685K182722XLR8 Abdominal Wound Dressing KitOMP2019-09-27
138581720137529K180840UNO Negative Pressure Wound Therapy SystemOMP2018-11-30
1827541720137529K180840UNO Negative Pressure Wound Therapy SystemOMP2018-11-30
3421021899233727K180840UNO Negative Pressure Wound Therapy SystemOMP2018-11-30
138581989237257K161599UNO Negative Pressure Wound Therapy SystemOMP2017-04-06
1827541989237257K161599UNO Negative Pressure Wound Therapy SystemOMP2017-04-06
138581027972626K143726XLR8 PLUS (XLR8+)OMP2015-06-19
3421021754172418K143726XLR8 PLUS (XLR8+)OMP2015-06-19
3421021184905376K142646XLR8 White Foam Dressing Kit and XLR8 White Foam Small Dressing Kit andOMP2015-04-30
1827542009159317K142646XLR8 White Foam Dressing Kit and XLR8 White Foam Small Dressing Kit andOMP2015-04-30
1827541653424409K141961GENADYNE SPIRO FOAM DRESSING KITOMP2015-03-26
3421021849925265K141961GENADYNE SPIRO FOAM DRESSING KITOMP2015-03-26
1827541020192896K120920HSINER CPAP SILICONE NASAL MASK SIZE XS/PETITE HSINER NASAL PILLOW MASK HSINER INFANT CPAP CANNULABZD2012-07-16
138582014372185K112856LUCINA-MELODIHGX2012-05-10
138581154764513K102516LUCINA MODEL MELODIHGX2011-08-11
3421021642842277K092992A4-XLR8 FOAM DRESSINGOMP2010-06-29
1827541923189117K092992A4-XLR8 FOAM DRESSINGOMP2010-06-29
138581923189117K092992A4-XLR8 FOAM DRESSINGOMP2010-06-29
138581516589917K090638GENADYNE A4-XLR8 WOUND VACUUM SYSTEMOMP2009-04-29
138581016156957K082676GENADYNE A4 WOUND VACUUM SYSTEMOMP2008-12-18
138581137164404
138581225198442
138581705774173
138581726702599
138581813383619
1827541935785150
138581935785150
1827541944896791
138581944896791
138582053781683
138582072351805

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OMP342026-03-12
BZD32024-12-31
HGX22012-05-10

PMN#

GUDID#

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