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
30437446623043744662Wen 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
2134011925434989K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)GEX2026-08-27
2134011898832208K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)GEX2026-09-17
2134011663117900K2615891927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02)GEX2026-09-02
2134011952185882K261582Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02)NUV2026-08-28
2937641017747530K260307Diode Laser Therapy Systems (V19)GEX2026-04-15
3474791244630221K253790High Intensity Focused Electromagnetic Stimulation Device (FE60)NGX2026-08-13
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
3181231855668251K222920Oxygen concentratorCAW2023-07-20
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

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GEX322026-09-17
LZA92024-04-04
ONF72023-04-21
NGX52026-08-13
DPS52018-01-22
DXN42021-04-28
LZC42018-08-10
DQA42015-04-23
KNG32024-06-14
IYO32024-05-03
CAW22023-07-20
KGO22014-12-22
MWI22010-06-11
NUV12026-08-28
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
LYZ12018-09-21
CBP12017-11-17
OOK12017-11-01
JIO12012-04-17
MLO12011-09-30
MHX12011-06-28