Wen Xu

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30069796783006979678Wen Xu1N2026-01-014611 Maydew Mews Way Ellicott City MD US 21042
30075494393007549439Wen Xu1N2026-01-014611 Maydew Mews Way Ellicott City MD Ellicott MD US 21042
30093916513009391651Wen Xu1N2026-01-014611 Maydew Mews Way Ellicott City MD Ellicott MD US 21042
30094446463009444646Wen Xu1N2026-01-014611 Maydew Mews Way Ellicott City MD US 21042
30097478103009747810Wen Xu1N2026-01-014611 Maydew Mews Way Ellicott City MD Ellicott MD US 21042
30105829523010582952Wen Xu1N2026-01-014611 Maydew Mews Way Ellicott MD US 21042
30120340173012034017Wen Xu1N2026-01-014611 Maydew Mews Way Ellicott MD US 21042
30127991153012799115Wen Xu1N2026-01-014611 Maydew Mews Way Ellicott MD US 21042
30136130433013613043Wen Xu1N2026-01-014611 Maydew Mews Way Ellicott MD US 21042
30161704533016170453Wen Xu1N2026-01-014611 Maydew Mews Way Ellicott MD US 21042
30165899693016589969Wen Xu1N2026-01-014611 Maydew Mews Way Ellicott MD US 21042
30171783583017178358Wen Xu1N2026-01-014611 Maydew Mews Way Ellicott City MD Ellicott MD US 21042
30213153703021315370Wen Xu1N2026-01-014611 Maydew Mews Way Ellicott City MD Ellicott MD US 21042
30213809803021380980Wen Xu1N2026-01-014611 Maydew Mews Way Ellicott City MD Ellicott MD US 21042
30262949853026294985Wen Xu1N2026-01-014611 Maydew Mews Way Ellicott City MD Ellicott MD US 21042
30273325083027332508Wen Xu1N2026-01-014611 Maydew Mews Way Ellicott City MD Ellicott MD US 21042
30276055073027605507Wen Xu1N2026-01-014611 Maydew Mews Way Ellicott MD US 21042
30367548773036754877Wen Xu1N2026-01-014611 Maydew Mews Way Ellicott City MD Ellicott MD US 21042
30436573943043657394Wen Xu1N2026-01-014611 Maydew Mews Way Ellicott City MD US 21042
00Wen Xu5N2020-04-254611 Maydew Mews Way Ellicott City MD Ellicott MD US 21042
30144988543014498854Wen Xu1N2020-04-254611 Maydew Mews Way Ellicott City MD Ellicott MD US 21042
30153374253015337425Wen Xu1N2020-04-254611 Maydew Mews Way Ellicott MD US 21042

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2134011862612153K2527321927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02)GEX2025-10-23
2134011398622212K251339Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04)GEX2025-07-25
2134011114567985K250782Fractional CO2 Laser MachineGEX2025-06-12
2993351864630399K250722Nd: YAG Laser Therapy System (QN-1)GEX2025-06-06
3181231819600209K250431Medical Diode Laser Hair Removal System (MNLT-D1)GEX2025-05-12
2134011916365149K250041Medical Picosecond ND: YAG Laser System (PZ-6)GEX2025-05-14
2134011840008123K250038Muscle Stimulator Device (PZ-100)NGX2025-05-19
2937641581848258K242183Fractional CO2 Laser Therapy System (EXFU CO2)GEX2024-10-23
3474791532830340K241860Diode Laser Hair Removal SystemGEX2024-09-25
3124861131874010K241547Diode Laser Therapy Device (DF-DIODE LASER-S1)GEX2024-08-13
3281071113027511K241074High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors (Straight Handpieces: SCHD05-S, SCHD16-S, SCHD17-S, SCHD24-S, SCHD27-S Geared Angle Handpieces: SCHD05-C, SCHD06-C, SCHD16-C, SCHD17-C, SCHD24-C, SCHD27-C, SCHD29-S, SCHB4, SCHB5, SCHB20, SCHB64 Air Motors: SCHD16-M, SCHD17-M, SCHD24-M, SCHD27-M)EFB2024-11-12
2993351431048617K2406581060nm laser body slimming machinePKT2024-05-13
1637041543867903K240361Powder Free Green Nitrile Examination Gloves (XS/S/M/L/XL); Powder Free Pink Nitrile Examination Gloves (XS/S/M/L/XL); Powder Free Purple Nitrile Examination Gloves (XS/S/M/L/XL)LZA2024-04-04
2351311533617439K232982EMS Sculpt MachineNGX2024-11-25
2705551704453891K232969Disposable Hemostatic ClipsPKL2024-06-07
857791764163691K232908Color Doppler Ultrasound Diagnostic System (CMS1700B), Color Doppler Ultrasound Diagnostic System (CMS1700C)IYN2024-05-02
857791965682112K232895B-Ultrasound Diagnostic SystemIYO2024-05-03
857791274644983K232893Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F)KNG2024-06-14
3001331428934671K232532Nd:Yag Laser Therapy SystemsGEX2023-11-02
2705551003194546K232200Disposable Injection NeedlesFBK2024-04-12
2993351447688579K232181Body Contouring Machine (Models: CS2, CS3, CS5, CS7, CS8, CS11, CS13)NGX2024-04-24
3181231936105075K231318Electromagnetic Stimulator Device(Model EM Contouring and Tesla Duet)NGX2023-07-07
2351311093185530K230816Intense Pulsed Light Treatment SystemONF2023-04-21
2709911311341123K222916US 450 Diode Laser EquipmentGEX2022-12-09
1440411952991223K221472Filter and HME/FilterCAH2023-02-08
3474791766369671K221246IPL Hair Removal (Model: SL-B080, SL-B126, SL-B136)OHT2022-07-07
2709911852319929K220385Intense Pulsed Light EquipmentONF2022-08-12
857791090109308K220245Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)KNG2022-09-28
3001332014527572K212978Diode laser therapy systemGEX2021-11-10
2709912031706328K212611CO2 Laser EquipmentGEX2022-02-01
1534371566739353K210168Diode Laser Therapy SystemsGEX2021-05-10
2351311956072885K202758Nd: YAG Laser Therapy Systems HM-YL900GEX2020-11-16
857791022402566K202757CONTEC08A Electronic Sphygmomanometer, CONTEC08C Electronic Sphygmomanometer, ABPM50 Automatic Blood Pressure MonitorDXN2021-04-28
2993351449287552K202257Dermatological Diode Laser SystemsGEX2021-04-23
2993351525781362K202250Dermatological Carbon Dioxide Laser SystemsGEX2020-11-25
857791327582623K201980Infrared ThermometerFLL2020-12-18
2351311475470325K200751Photodynamic Therapy (PDT) EquipmentGEX2020-05-21
2937641521172296K200525Medical Diode Laser Hair Removal SystemGEX2020-05-27
1905481785074041K200093Synthetic Nitrile Patient Exam Gloves, Powder Free, Blue, Tested for Use w/Chemotherapy DrugLZA2020-08-20
1534371436037131K193477Nd: YAG Laser Therapy SystemsGEX2020-06-24
2709911871901406K193328IPL + Diode Laser MachineONF2020-03-25
2351311516067387K192528CO2 Laser Therapy SystemGEX2019-12-03
2351311618219059K192521Intense Pulsed Light Treatment SystemONF2019-12-06
2385201009547362K190954Fundus CameraHKI2020-01-22
1637041236927642K182043Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored)LYZ2018-09-21
1637041577465990K181130Powder Free Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy DrugsLZC2018-08-10
857791586990039K180837CONTEC Oxygen ConcentratorCAW2019-01-10
2134011642311556K180353Diode laser hair removal deviceGEX2018-04-17
3181231293255000K172144CoolSculpting SystemOOK2017-11-01
1905481588651786K171961Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower Infant CPR Mask, Compower Non-Rebreathing Valve (22mm/15mmOD), Non-Rebreathing Valve (22mm/18.5mm)CBP2017-11-17
857791482367403K171360CONTECâ„¢ ElectrocardiographDPS2018-01-22
857791191175063K170954Portable ECG MonitorDPS2017-05-30
857791538284452K170856CMS600P2 B-Ultrasound Diagnostic SystemIYO2017-11-17
857791763033641K170856CMS600P2 B-Ultrasound Diagnostic SystemIYO2017-11-17
1637041903269591K163146POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy DrugsLZC2017-02-13
2351311496478162K162659Diode Laser Hair Removal SystemGEX2017-06-16
857791441219051K152863Portable ECG MonitorDPS2016-06-22
1637041973322049K150340POWDER FREE Nitrile GLOVES (White), POWDER FREE Nitrile GLOVES (Cobalt Blue), POWDER FREE Nitrile GLOVES (Black), POWDER FREE Nitrile GLOVES (Ice Blue)LZA2015-06-18
857791570382061K141362PULSE OXIMETER CMS50EWDQA2015-04-23
1637041212356368K140989POWDER FREE NITRILE SURGICAL GLOVES, WHITE COLOR (BRAND NAME: TITANFINE)KGO2014-12-22
1637041692237471K140988POWDER FREE STERILE LATEX SURGICAL GLOVE, YELLOW COLOR (BRAND NAME: TITANFINE)KGO2014-08-12
857791850949167K131900CONTEC ELECTROCARDIOGRAPHDPS2014-03-05
1637041783297780K131440POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUELZA2013-09-25
1534371296795857K122995INTENSE PULSED LIGHT (IPL) SYSTEMSONF2013-01-22
1905481812931967K121526POWER-FREE NITRILE PATIENT EXAMINATION GLOVESLZA2012-08-03
857792008779082K111999HEALGEN 11 REAGENT STRIP FOR URINALYSIS, HEALGEN 10 REAGENT STRIP FOR URINALYSIS, AND HEALGEN 4 REAGENT STRIP FOR URINALJIO2012-04-17
1637041408668293K110921NITRILE POWDER-FREE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGSLZA2011-04-15
857791920311695K110775ELECTRONIC SPHYGMOMANOMETERDXN2011-05-13
857791079585823K110774ELECTRONIC SPHYGMOMANOMETERDXN2011-05-13
857791300002585K110156AMBULATORY BLLOD PRESSURE MONITOR, ELECTRONIC SPHYGMOMANOMETER,DXN2011-07-27
857791043627143K101692PATIENT MONITORMHX2011-06-28
857791622829258K101273DYNAMIC ECG SYSTEM MODEL TLC5000MLO2011-09-30
857791225967455K101127PATIENT MONITOR, MODEL PM50MWI2010-06-11
857791754640472K090936SINGLE-CHANNEL HANDHELD ELECTROCARDIOGRAPH, MODEL ECG80ADPS2009-08-25
857791030218455K090671PULSE OXIMETER, MODELS CMS50E, CMS50F, CMS60C, CMS60DDQA2009-06-11
857791138300605K082641FINGERTIP PULSE OXIMETER, MODELS CMS-50D, CMS-50L, CMS-50DLDQA2008-11-10
857791364416144K082480CONTEC POCKET FETAL DOPPLERKNG2009-02-25
3474791462251726K081015CERALAS D 980NM DIODE LASER, MODELS D15 AND D25GEX2008-07-08
857791290296456K073454FINGERTIP PULSE OXIMETER, MODEL CMS-50CDQA2008-05-05
857791023080089
2183081030615818
2183081065785536
1440411147509819
2183081223546026
2183081298326057
2404911412350947
2183081440356203
857791593589909
2183081605105052
1440411616980855
1440411635543545
1440411681413662
1440411706527041
2404911755283100
857791808230168
2183081901604959
1440411953753370
2287671966511088
2183082008933950
1905481011270106
1440411015613878
3370131019333941
3474791026898884
2705551039539524
3474791040187432
2709911044491632
3281071053214321
3181231072145771
2351311079897164

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GEX262025-10-23
LZA92024-04-04
ONF72023-04-21
DPS52018-01-22
NGX42025-05-19
DXN42021-04-28
LZC42018-08-10
DQA42015-04-23
KNG32024-06-14
IYO32024-05-03
KGO22014-12-22
MWI22010-06-11
EFB12024-11-12
PKL12024-06-07
PKT12024-05-13
IYN12024-05-02
FBK12024-04-12
CAH12023-02-08
OHT12022-07-07
FLL12020-12-18
HKI12020-01-22
CAW12019-01-10
LYZ12018-09-21
CBP12017-11-17
OOK12017-11-01
JIO12012-04-17
MLO12011-09-30
MHX12011-06-28