Yong Sun

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
Yong Sun5N2026-01-012500 Bee Cave Road, Building 1, Suite 300 Austin TX US 78746
Yong Sun5N2026-01-012500 Bee Cave Rd. Bldg. 1, Ste. 300 Austin TX US 78746
80100023002806407Yong Sun1N2026-01-012500 Bee Cave Rd. Bldg. 1, Ste. 300 Austin TX US 78746
80103423002853098Yong Sun1N2026-01-012500 Bee Cave Rd. Bldg. 1, Ste. 300 Austin TX US 78746
80104454395Yong Sun1N2026-01-012500 Bee Caves Rd Ste 1 Ste 300 Austin TX US 78746
80221296499Yong Sun1N2026-01-012500 Bee Cave Rd. Bldg. 1, Ste. 300 Austin TX US 78746
80303431000550480Yong Sun1N2026-01-012500 Bee Cave Rd. Bldg. 1, Ste. 300 Austin TX US 78746
80433163003319165Yong Sun1N2026-01-012500 Bee Cave Rd. Bldg. 1, Ste. 300 Austin TX US 78746
80438893003206796Yong Sun1N2026-01-012500 Bee Cave Rd. Bldg. 1, Ste. 300 Austin TX US 78746
96139943009084570Yong Sun1N2026-01-012500 Bee Cave Rd. Bldg. 1, Ste. 300 Austin TX US 78746
96139973002563423Yong Sun1N2026-01-012500 Bee Cave Rd. Bldg. 1, Ste. 300 Austin TX US 78746
96160033007610287Yong Sun1N2026-01-012500 Bee Cave Rd. Bldg. 1, Ste. 300 Austin TX US 78746
96176553003779679Yong Sun1N2026-01-012500 Bee Cave Rd. Bldg. 1, Ste. 300 Austin TX US 78746
96806703004423995Yong Sun1N2026-01-012500 Bee Cave Rd. Bldg. 1, Ste. 300 Austin TX US 78746
96808093002995060Yong Sun1N2026-01-012500 Bee Cave Rd. Bldg. 1, Ste. 300 Austin TX US 78746
10003512761000351276Yong Sun1N2026-01-012500 Bee Cave Rd. Bldg. 1, Ste. 300 Austin TX US 78746
10004253151000425315Yong Sun1N2026-01-012500 Bee Cave Rd. Bldg. 1, Ste. 300 Austin TX US 78746
10005998681000599868Yong Sun1N2026-01-012500 Bee Cave Rd. Bldg. 1, Ste. 300 Austin TX US 78746
10006011801000601180Yong Sun1N2026-01-012500 Bee Cave Rd. Bldg. 1, Ste. 300 Austin TX US 78746
30023042833002304283Yong Sun1N2026-01-012500 Bee Cave Rd. Bldg. 1, Ste. 300 Austin TX US 78746
30026542353002654235Yong Sun1N2026-01-012500 Bee Cave Rd. Bldg. 1, Ste. 300 Austin TX US 78746
30026928863002692886Yong Sun1N2026-01-012500 Bee Cave Rd. Bldg. 1, Ste. 300 Austin TX US 78746
30030183043003018304Yong Sun1N2026-01-012500 Bee Cave Rd. Bldg. 1, Ste. 300 Austin TX US 78746
30033997033003399703Yong Sun1N2026-01-012500 Bee Cave Rd. Bldg. 1, Ste. 300 Austin TX US 78746
30033997073003399707Yong Sun1N2026-01-012500 Bee Cave Rd. Bldg. 1, Ste. 300 Austin TX US 78746

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
175391625641225K994312MALE LATEX CONDOM 56MMHIS2000-03-21
175391829222601K994311MALE LATEX CONDOM WITH VANILLA FLAVORHIS2000-03-21
526561238771587K993411FEMISCAN CLINIC SYSTEM, MODEL FS-ICTRA AND FEMISCAN PERSONAL SYSTEM, MODEL FS-HMTRHIR2000-01-10
116561513673257K9918611ST RESPONSE INFANT MANUAL RESUSCITATOR, BAG RESEVOIR, 1ST RESPONSE PEDIATRIC MANUAL RESUSCITATOR, BAG RESERVOIR, 1ST REBTM2000-01-18
114291872173722K990013EVERGREEN NON-STERILE POWDER-FREE, COLORED NITRILE EXAMINATION GLOVESLZA1999-03-23
175391804778346K982380SUREHIS1999-02-26
533811199315133K981750WIELISA ANTI-GBM, ANCA SCREENING KIT TEST SYSTEMMOB1998-07-22
533811698531021K974169WIELISA ANTI-GBM TEST SYSTEMDBL1998-02-17
526561472972490K963202MEGA ME 3000 PROFESSIONAL MUSCLE TESTERHCC1997-05-19
116561680275181K953230CPR SUPER POCKET PACKCBP1996-02-14
533811518308652K952183DIASTAT ANTI-THYROGLOBULIN KITJZO1995-06-30
152711139565200K943935GIP/MEDI-GLOBE POLYPECTOMY SNARESFDI1995-05-26
91601580807725K942826ORTHODONITC METAL REINFORCED PLASTIC BRACKETDYW1994-12-14
91601551931549K932825MICROARCH GOLD BRACKETEJF1994-05-09
91601594290717K932025ION-IMPLANTED NEO SENTALLOYEJF1993-09-13
533811387849573K921183DIASTAT ANTI-MITOCHONDRIAL ANTIBODY KITDBM1992-06-19
91601644324384K920784ORTHODONTIC FACE BOW W/ INNER WIREDZB1992-03-20
533811724246525K905386DISTAT ANTI-DSDNA KITKTL1990-12-13
116561074860260K895589MANUAL RESUSCITATORBTM1990-03-30
91601782082577K852179CERAMIC ORTHODONIT APPLIANCEEJF1985-08-20
152711196199272K251658Endoflux™ Biliary & Pancreatic Stent SetsFGE2026-04-16
842081015625889K251615Aerogen Pro-X1 Controller SystemSFP2025-09-02
114291401269259K241909Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric AcidLZA2024-09-27
842081293595364K232507Aerogen®Solo Nebulizer SystemCAF2024-05-10
3508811968230204K223397HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens, HOYA Illumina (sorafilcon A) Toric Daily Disposable Soft Contact Lens, HOYA Illumina (sorafilcon A) Multifocal Daily Disposable Soft Contact LensLPL2024-01-03
114291854005449K220644Non-sterile, Powder Free, ambidextrous, textured, beaded cuff, single use, Doffy® Nitrile Examination Glove, Tested for use with Chemotherapy DrugsLZA2023-03-25
114292036446206K202536Non-sterile, Powder Free Nitrile Examination Aloe Vera Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, And Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs and Fentanyl CitrateLZA2021-08-11
114291476091611K201390Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with Chemotherapy Drugs)LZC2020-09-18
114291678580310K200150Medline Powder-Free Orange Nitrile Patient Examination Glove (Tested for use with Fentanyl)LZA2020-10-26
114291788061698K193666Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy and Fentanyl) – Regular Cuff; Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl) - Extended CuffLZA2020-08-04
114291822880069K191230Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam GlovesLZC2019-11-08
526561763752702K182030Faros MobileMLO2018-11-08
91601803513161K180718ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIESDYW2018-10-30
114291090274336K180646Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy DrugsLZC2018-06-27
1740691972370525K173341Vivid E80, Vivid E90, Vivid E95IYN2017-11-02
114292070300397K171104Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Blue, Cobalt Blue)LZA2017-08-25
2258981516592217K170147Lucica Glycated Albumin-LLCP2017-10-12
114291529613963K162095Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue)LZA2016-11-02
91601963472685K160615ORTHODONTIC CERAMIC BRACKETS 1.1NJM2016-08-26
1403211823618829K153344Asahi REXEED-S Series DialyzerKDI2015-12-17
842082063154463K143719Aeroneb USB Contoller SystemCAF2015-07-10
526561573738606K143032eMotion Faros ECG MobileDXH2015-03-29
114291044680021K142283Non-Sterile, Powder Free Nitrile Examination Gloves (Blue, Black and White Color)LZA2015-01-16
152711006688981K133763SONOTIP PRO AND PRO FLEX EBUS-TBNA NEEDLE SYSTEMFCG2014-05-15
842081603702472K133360AERONEB SOLO; AERONEB SOLO ADAPTERCAF2014-10-17
114291419006177K133123NON STERILE, POWEDER FREE BLUE NITRILE EXAMINATION GLOVES - 8623FLZA2014-05-30
116561963709276K132679AF VIRAL/BACTERIAL FILTER, BF VIRAL/BACTERIAL FILTERCAH2014-04-18
526562070163014K131699EMOTION ECG MOBILEDXH2013-11-26
91601993642201K123092CERAMIN BRACKETS ZNJM2012-12-21
116561577859590K122627GIO DIGITAL PRESSURE GUAGESCAP2013-08-22
114291048256503K121464BLUE POWER FREE NITRILE EXAMINATION GLOVELZA2012-07-05
114292049199232K113423KIMBERLY CLARK PURPLE NITRILE, AND PURPLE NITRILE XTRA POWDER FREE EXAM GLOVELZA2012-03-09
116561951969381K112852BABI PLUS NEONATAL RESUSCITATION BAGBTM2012-01-13
114291940170764K111248NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVES (ORIGINAL BLUE, COBALT BLUE)LZA2011-12-01
114291270380416K110921NITRILE POWDER-FREE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGSLZA2011-04-15
116561065675368K110471BABI PLUS INFANT NASAL CANNULA SYSTEMBZD2011-10-07
116561822583785K110383BABI*PLUS PRESSURE RELIEF MANIFOLD - 10CM H20, 12.5CM H20, 15CM H20BZD2011-08-01
842081200335151K103635CONTINUOUS NEBULIZATION TUBE SET (CNTS) TUBING: AG-AS3075 + SYRINGE: AG-AS3085; CONTINOUS NEBULIZATION TUBE SET (CNTS) SCAF2011-05-13
116561346202028K103316FLOWRESTBTT2011-02-08
407721775138326K10286484E SERIES SINGLE PLY WRAPPERFRG2011-01-14
116561890358197K102377VENTIPLUS DISPOSABLE MANOMETER 0-60 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0-20 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0CAP2010-11-18
842081190907403K102240NIVO NEBULIZER SYSTEMCAF2010-11-10
114291642939130K101820NON-STERILE, BLUE & WHITE POWDERED NITRILE EXAMINATION GLOVESLZA2011-03-03
114291976746768K101596KIMBERLY-CLARK PURPLE NITRILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) AND KIMBERLY-CLARK PURPLE NITRILE XTRA POWDER-LZC2010-07-21
116561268683813K093716BABI PLUS INFANT NASAL CANNULA SYSTEMBZD2010-05-13
563901191500282K093010MACH LED MCFSY2010-04-01
563901064638800K093009MACH LED SCFSY2010-04-01
116561101573796K092687VENTI.PLUS HYPERINFLATION BAG SYSTEM WITH PRESSURE MANOMETERNHK2009-11-23
407721331607908K092344LAC-MAC INNERBLOC LR SURGICAL GOWNSFYA2009-12-17
91601143133927K092030ELATION MB METAL REINFORCED PLASTIC BRACKETDYW2009-07-24
116561360593694K091862NESSI SPACERNVO2009-11-20
533811368570921K091657IMMUNOSCAN CCPLUSNHX2009-11-19
91601631325847K090454ALLURE MB CERAMIC BRACKETSNJM2009-03-20
116561648713695K090317BABI*PLUS BUBBLE PAP VALVEBYE2009-05-20
152711779342194K083802SONOTIP II 25-GAUGE ULTRASOUND NEEDLE SYSTEM, MODELS GUS-01-18-025 AND GUS-01-27-025FCG2009-03-20
91601281679487K082974MYSTIQUE MB CERAMIC BRACKETSNJM2008-11-07
116561601329185K082092DISPO-BAG MANUAL RESUSCITATOR, DISPOSABLE ADJUSTABLE PEEP VALVE, DISPOSABLE FIXED PEEP VALVEBTM2008-10-15
842081426983255K081650AERONEB GO NEBULIZERCAF2008-10-23
114291630621907K081260KIMBERLY-CLARK *LAVENDER* NITRILE POWER-FREE EXAM GLOVESLZA2008-07-09
114291836262106K081089KIMBERLY-CLARK STERLING NITRILE & NITRILE-XTRA POWDER-FREE EXAM GLOVES WITH CHEMOTHERAPY DRUG USE CLAIMLZC2008-07-14
116561708960315K080149HEATER BASE, MODEL PMH7000BTT2008-12-18
116561820897860K072755GALEMED CPAP MASKBZD2007-11-16
842081682978327K070642AERONEB PROFESSIONAL NEBULIZER SYSTEMCAF2007-05-07
152711798346049K070129SONOTIP II ULTRASOUND NEEDLE SYSTEMFCG2007-01-31
533811931478032K062045EDIA ANTI-CCPNHX2006-12-04
114291714951272K061553NON-STERILE, POWDER-FREE BLACK NITRILE EXAMINATION GLOVESLZA2006-07-17
407721767348696K061491LAC-MAC INNERBLOC O.R. GOWNFYA2006-08-09
152711658036774K061222INJECTRA INJECTION NEEDLEFBK2006-07-03
91601436037402K060837IN-OVATION CNJM2006-04-10
105401303409636K053638MANI NEEDLE & SUTURE PACK (SILK)GAP2006-05-19
105401663866096K053637MANI NEEDLE & SUTURE PACK (NYLON)GAR2006-05-19
105401900732372K053636MANI NEEDLE & SUTURE PACK (PGA ABSORBABLE)GAM2006-03-14
91602061196733K052370CP BRACKET SYSTEMDYW2005-11-01
116561154149985K051279CALDYNE, INC. EXHALOMETER EX100, MODEL EX100BZK2005-09-07
593461907637459K051013SPINEMED S200B/S200CITH2005-04-27
105401646270225K050150MANI NEEDLE & SUTURE PACKGAT2005-12-05
91601664146339K042178ORTHODONTIC CERAMIC BRACKETSNJM2004-08-30
407721644367008K032631INNERBLOC LR SURGICAL GOWNS BASED ON GORE LR FABRIC (REUSABLE 100X)FYA2004-02-05
407721484371730K031362LAC-MAC LIMITED INNERBLOC VARIOUS O.R. DRAPE BASED ON THE REPEL, PLUS AND GORE SURGICAL BARRIER FABRIC MATERIALSKKX2003-05-30
407721665416120K030536LAC-MAC LIMITED INNERBLOC O.R. GOWNFYA2003-05-06
842081675647049K030271VENTLAB BACTERIAL FILTER, MODEL BF100CAH2003-07-07
116561147491539K0237931ST RESPONSE INTERMEDIATE MANUAL RESUSCITATORBTM2003-02-11
175391902009329K023333MULTIPLE, MALE LATEX CONDOM [52MM OR 56MM NOMINAL WIDTH WITH SMOOTH OR DOTTED OR RIBBED OR 3 IN 1 (DOTTED/RIBBED/CONTOURHIS2003-06-23
114291487195914K022765NITRILE POWDER-FREE EXAMINATION GLOVESLZA2002-10-11
175391436033794K022156LATEX ULTRASONIC PROBE COVERITX2003-09-11
116561914182145K022124GALEMED PEAK FLOW METER, MODELS 3751/3752BZH2003-04-03
116561374500448K021742GALEMED NEB-EASY NEBULIZERCAF2002-10-25
842081783479213K021175AERONEB PROFESSIONAL NEBULIZER SYSTEM, MODEL#AG-AP6000CAF2002-05-15
533811467104431K020687DIASTAT ANTI-THYROID PEROXIDASE ELISA MODEL #300JZO2002-05-02
175391956880824K020272MALE LATEX CONDOM WITH RIBBED SURFACEHIS2002-04-26
116561599808087K0141151ST RESPONSE MANUAL RESUSCITATOR, MODEL 85XXBTM2002-02-27
175391752493772K002571MULITPLE MALE LATX CONDOMHIS2000-11-16
175391887874733K001377SPERMICIDAL LUBRICATED MALE LATEX CONDOMLTZ2000-06-08
175391261629304K001221MALE LATEX COMDOM WITH DOTTED SURFACEHIS2000-05-19
105401015208406
105411015208406
105401032999213
91601033502286
105401037330791

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
LZA182024-09-27
CAF92024-05-10
HIS72003-06-23
NJM62016-08-26
BTM62012-01-13
LZC52020-09-18
BZD52011-10-07
DYW42018-10-30
FYA42009-12-17
FCG32014-05-15
EJF31994-05-09
DXH22015-03-29
CAH22014-04-18
CAP22013-08-22
BTT22011-02-08
FSY22010-04-01
NHX22009-11-19
JZO22002-05-02
FGE12026-04-16
SFP12025-09-02
LPL12024-01-03
MLO12018-11-08
IYN12017-11-02
LCP12017-10-12
KDI12015-12-17
FRG12011-01-14
NHK12009-11-23
NVO12009-11-20
BYE12009-05-20
FBK12006-07-03
GAR12006-05-19
GAP12006-05-19
GAM12006-03-14
GAT12005-12-05
BZK12005-09-07
ITH12005-04-27
ITX12003-09-11
KKX12003-05-30
BZH12003-04-03
LTZ12000-06-08