FDA.report

DUKAL LLC

Matched from indexed company URL: Dukal LLC

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
24359461000137528DUKAL LLC1Y2026-01-012 Fleetwood Ct. Ronkonkoma NY US 11779

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
458801390998310K993764MEDIPACK SEE-THROUGH SEAL STERILIZATION POUCHKCT1999-12-16
458801271628268K981970ALGETRAL, CAVEX CHROMATIC, CA 37 SUPERIOR PINK, CA 37 FAST SET, CAVEX RAINBOW, CAVEX IMPRESSIONAL NORMAL SETTING, CAVEXIELW1998-09-02
458801368166464K971849CYTOLOGY BRUSHHHT1997-07-24
458801105756901K964321GLOVE, PATIENT EXAMINATION, VINYL (POWDERED)LYZ1997-01-09
458801997586426K955476DUKAL TRANSPARENT WOUND DRESSINGMGP1996-01-18
458801467119978K953505BURNAID BURN FIRST AID DRESSINGMGQ1996-02-09
458801192256567K940440DUKAL NON-WOVEN GAUZEEFQ1994-03-09
458801201461671K940339IODOFORM PACKAGING STRIPFRO1994-02-25
458801275877717K936095GAUZE SPONGEEFQ1994-02-02
458801885487493K931005DUKAL SKIN CLOSURE STRIPFPX1993-07-14
458801407057864K903590KEJUMP DIGITAL CLINICAL THERMOMETERFLL1990-10-22
458801962221402K861154ALBA HEALTH CARE PLAIN PACKING STRIPEFQ1986-04-15
458802048405208K850241ALBA HEALTH CARE NON-ADHERING DRESSINGFRO1985-03-12
458801837147714K813535XEROFORM DRESSINGFRO1982-02-04
458801295070223K780715ANEROID TYPE BLOOD PRESSURE KITDXQ1978-07-17
458801163360888K241789Non-Sterile Ultrasound Transmission GelsMUI2024-07-24
458801503409417K241036Autoclave Indicator Tape; EO Indicator TapeJOJ2024-12-17
458801118595501K221999Ultrasound Transmission GelsMUI2022-08-30
458801473170079K221755Antimicrobial gauze sponge dressing; Antimicrobial super sponge dressing; Antimicrobial non-woven sponge dressingFRO2023-01-13
458801683798773K220673Sterile Silver Alginate Wound DressingFRO2023-03-16
458801282361943K201732Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation Level 3 Surgical Face Masks with Tie OnFXX2021-02-16
458801981000284K201421Dukal Corporation Level 2 Surgical Mask with Ear Loops; Dukal Corporation Level 2 Surgical Mask with Ear Loops and Face Shield; Dukal Corporation Level 2 Surgical Mask with Adjustable Tie OnsFXX2021-02-05
458801692665333K193259Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometerDXQ2020-07-02
458801225297096K183263UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier EnvelopePEM2019-06-14
458801278316389K162258Self Sealing Sterilization PouchesFRG2017-04-28
458801426749776K153496Disposable Surgical Face MaskFXX2016-06-15
458801839148037K151535Cavex Cream AlginateELW2015-10-28
458801926619214K142892Powder-free Clear Vinyl Patient Examination GlovesLYZ2015-03-25
458801781216895K132709VR MEDICAL HEAT AND MOISTURE EXCHANGER AND FILTERCAH2014-07-30
458801864860798K130117NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDSHOZ2013-10-29
458801582263265K121992POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLORLZA2012-10-16
458801265987975K120526YUYUE K2 WHEELCHAIR, YUYUE K4 WHEELCHAIRIOR2012-03-08
458801760737403K113689DUKAL LUBRICATING JELLYKMJ2012-05-04
458801336577469K111067JIE+HONG MEDICAL SURGICAL GOWNS - STERILE, JIE+HONG MEDICAL SURGICAL GOWNS - NON STERILEFYA2011-08-02
458801199660071K110981
458802048448235K101114ADVANCIS ACTIVON TUBEFRO2011-07-26
458801526616250K091272BESMED JET NEBULIZER BOTTLE SETCAF2009-11-10
458801269631646K082542ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE MODEL HBPK-ADXQ2008-09-17
458801476517734K070692DUKAL N95PARTICULATE RESPIRATOR/SURGICAL FACE MASKMSH2007-05-30
458801358383316K070407DUKAL SURGICAL FACE MASK TIE, EAR LOOP, WITH SHIELD YELLOW & WHITE; ANTI FOG TIE, LOOP, SHIELD, YELLOW, WHITE, AND BLUEFXX2007-03-26
458801058118951K062675GEMORE REUSEABLE SELF ADHESIVE ELECTRODE, MODELS WIRE SERIES, SNAP SERIES AND DOUBLE SIDE SERIESGXY2007-01-04
458801679326435K061864DUKAL SURGICAL FACE MASK TIE-ON, MODEL 1530; EAR LOOP, MODEL 1540; WITH SHIELD, MODEL 1560FXX2006-09-15
458801205120397K053254INFANT HEEL WARMER BY INTCOMPO2006-09-19
458801215300309K052468YK9000 SERIES MANUAL WHEELCHAIRIOR2005-10-05
458801763352223K051207CAVEX ORTHOTRACEELW2005-06-21
458801264531800K032720GEM-STIM TENS, MODELS GM3XY AND GM3AXYGZJ2003-12-10
458801644121308K020726DUKAL DISPOSABLE VAGINAL SPECULUM, SMALL, MEDIUM, AND LARGEHIB2002-05-15
458801682003037K012522WAVELENGTH MULTI-PURPOSE ULTRASOUND GELITX2001-10-18
458802038032092K011419CAVEX COLORCHANGEELW2001-07-16
458801948842924K003791CAVEX TEMPORARY CEMENTEMA2001-01-23
458801262995547K001896KENZ ECG 108 SINGLE CHANNEL DIGITAL ELECTROCARDIOGRAPHS; KENZ ECG 110 SINGLE CHANNEL DIGITAL ELECTROCARDIOGRAPHS WITH ECDPS2001-01-08
4588010059058621969-12-31
4588010059058621969-12-31
4588010059058621969-12-31
4588010059058621969-12-31
4588010117916891969-12-31
4588010117916891969-12-31
4588010117916891969-12-31
4588010117916891969-12-31
4588010321307751969-12-31
4588010321307751969-12-31
4588010321307751969-12-31
4588010321307751969-12-31
4588010975948781969-12-31
4588010975948781969-12-31
4588010975948781969-12-31
4588010975948781969-12-31
4588011197217431969-12-31
4588011197217431969-12-31
4588011197217431969-12-31
4588011197217431969-12-31
4588011331618151969-12-31
4588011331618151969-12-31
4588011331618151969-12-31
4588011331618151969-12-31
4588011390735241969-12-31
4588011390735241969-12-31
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4588011454725791969-12-31
4588011454725791969-12-31
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4588011717005031969-12-31
4588011717005031969-12-31
4588011717005031969-12-31
4588011717005031969-12-31
4588012033982731969-12-31
4588012033982731969-12-31
4588012033982731969-12-31
4588012033982731969-12-31
4588012057494271969-12-31
4588012057494271969-12-31
4588012057494271969-12-31
4588012057494271969-12-31
4588012230050851969-12-31
4588012230050851969-12-31
4588012230050851969-12-31
4588012230050851969-12-31
4588012459512671969-12-31
4588012459512671969-12-31
4588012459512671969-12-31
4588012459512671969-12-31
4588012848065291969-12-31
4588012848065291969-12-31
4588012848065291969-12-31
4588012848065291969-12-31
4588012922765961969-12-31
4588012922765961969-12-31
4588012922765961969-12-31
4588012922765961969-12-31
4588012928893461969-12-31
4588012928893461969-12-31
4588012928893461969-12-31
4588012928893461969-12-31
4588013434690711969-12-31
4588013434690711969-12-31
4588013434690711969-12-31
4588013434690711969-12-31
4588013547021441969-12-31

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
FRO62023-03-16
FXX52021-02-16
ELW42015-10-28
DXQ32020-07-02
EFQ31994-03-09
MUI22024-07-24
LYZ22015-03-25
IOR22012-03-08
JOJ12024-12-17
PEM12019-06-14
FRG12017-04-28
CAH12014-07-30
HOZ12013-10-29
LZA12012-10-16
KMJ12012-05-04
FYA12011-08-02
CAF12009-11-10
MSH12007-05-30
GXY12007-01-04
MPO12006-09-19
GZJ12003-12-10
HIB12002-05-15
ITX12001-10-18
EMA12001-01-23
DPS12001-01-08
KCT11999-12-16
HHT11997-07-24
MGQ11996-02-09
MGP11996-01-18
FPX11993-07-14
FLL11990-10-22

NDC

GUDID

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