FDA.reportPublic FDA data

Charles Shen

Matched from indexed company URL: Charles-Shen

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
Charles Shen5N2026-01-0137 Winding Rdg Oakland NJ US 07436
Charles Shen5N2026-01-0137 Winding Rdg Oakland NJ US 07436
30029938633002993863Charles Shen1N2026-01-0137 Winding Ridge Oakland NJ US 07436
30042646023004264602Charles Shen1N2026-01-0137 Winding Ridge Oakland NJ US 07436
30044728103005310494Charles Shen1N2026-01-0137 Winding Rdg Oakland NJ US 07436
30047485283004748528Charles Shen1N2026-01-0137 Winding Rdg Oakland NJ US 07436
30052802053005280205Charles Shen1N2026-01-0137 Winding Rdg Oakland NJ US 07436
30057850903005785090Charles Shen1N2026-01-0137 Winding Rdg Oakland NJ US 07436
30064372153006437215Charles SHEN1N2026-01-0137 Winding Rdg Oakland NJ US 07436
30071249793007124979Charles Shen1N2026-01-0137 Winding Rdg Oakland NJ US 07436
30080444753008044475Charles Shen1N2026-01-0137 Winding Rdg Oakland NJ US 07436
30082541253008254125Charles Shen1N2026-01-0137 Winding Rdg Oakland NJ US 07436
30083951183008395118Charles Shen1N2026-01-0137 Winding Ridge Oakland NJ US 07436
30085979953008597995Charles Shen1N2026-01-0137 Winding Rdg Oakland NJ US 07436
30098315163009831516Charles Shen1N2026-01-0137 Winding Ridge Oakland NJ US 07436
30099268363009926836Charles Shen1N2026-01-0137 Winding Rdg Oakland NJ US 07436
30101653083010165308Charles Shen1N2026-01-0137 Winding Ridge Oakland NJ US 07436
30103838313010383831Charles Shen1N2026-01-0137 Winding Rdg Oakland NJ US 07436
30104029643010402964Charles Shen1N2026-01-0137 WINDING RIDGE Oakland NJ US 07436
30105803213010580321Charles Shen1N2026-01-0137 Winding Rdg Oakland NJ US 07436
30114845203011484520Charles Shen1N2026-01-0137 Winding Rdg Oakland NJ US 07436
30124419633012441963Charles Shen1N2026-01-0137 Winding Rdg Oakland NJ US 07436
30126297413012629741Charles Shen1N2026-01-0137 Winding Rdg Oakland NJ US 07436
30168795603016879560Charles Shen1N2026-01-0137 Winding Ridge Oakland NJ US 07436
30179611143017961114Charles Shen1N2026-01-0137 Winding Ridge Oakland NJ US 07436

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1142031053784083K253973Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP SeriesEIH2026-01-09
1955621626554573K253973Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP SeriesEIH2026-01-09
1142031113407618K253380“FLNT Base” and “FLNT Temp”EBG2026-03-02
1955621275025464K253380“FLNT Base” and “FLNT Temp”EBG2026-03-02
2761871674393789K251667LED Light Therapy Mask (M01, M02, M06, M07, M08, M09)OHS2025-08-07
2924371473556461K240292Transcutaneous Electrical Nerve Stimulator (9029SCM)NUH2024-03-25
1142031328623220K240153Ceramic Etchant (HF-5 and HF-9)KLE2024-10-02
1142031202653316K231687Gradual Dental Zirconia BlankEIH2023-09-07
1955621275272035K231687Gradual Dental Zirconia BlankEIH2023-09-07
914471948721061K231088Copper Foam Dressing (Prescription and OTC)FRO2024-01-11
1950181509680357K230190Polyver Silver Alginate Dressing (Prescription and OTC)FRO2023-11-17
914471626315583K230190Polyver Silver Alginate Dressing (Prescription and OTC)FRO2023-11-17
2924371536001988K213788TENS&EMS STIMULATOR (Model: KRES100D, KRES1010, KRES1020, KRES1080)NUH2022-05-06
1965991138229119K202667Personal Lubricant JellyNUC2021-05-18
1049791103059344K190954Fundus CameraHKI2020-01-22
914471256838980K181478Roosin Xeroform Petrolatum DressingFRO2019-09-13
1950181452298023K181478Roosin Xeroform Petrolatum DressingFRO2019-09-13
1142031467680542K181167Upcera Glaze Paste, Glaze Powder, and Glaze LiquidEIH2018-09-02
1955621502544267K181167Upcera Glaze Paste, Glaze Powder, and Glaze LiquidEIH2018-09-02
1049791922117539K180207Non-contact Infrared ThermometerFLL2018-11-28
1142031067805489K162323Tooth Shade Resin MaterialEBF2017-01-12
1955621132376973K162323Tooth Shade Resin MaterialEBF2017-01-12
1049791727238601K152318MD-2300S Ultrasonic A/B Scanner for OphthalmologyIYO2015-11-17
1955621392348526K152175Upcera Dental Zirconia Blank for Aesthetic RestorationEIH2015-12-04
1142031654536674K152175Upcera Dental Zirconia Blank for Aesthetic RestorationEIH2015-12-04
1325761543278824K151745FULL CARE Disposable PVC Nelaton CatheterEZD2016-03-03
914471189801430K143335Roosin Silver Calcium Alginate Dressing (Prescription), Roosin Alginate Dressing with Preservative (OTC)FRO2015-06-01
1950181500302591K143335Roosin Silver Calcium Alginate Dressing (Prescription), Roosin Alginate Dressing with Preservative (OTC)FRO2015-06-01
1049791623360962K142263Applanation TonometerHKY2016-04-15
1142031341802344K141727DENTAL LITHIUM DISILICATE GLASS CERAMIC BLOCK (UP. PRESS SERIES AND UP. CAD SERIES)EIH2014-12-18
1955621806234623K141727DENTAL LITHIUM DISILICATE GLASS CERAMIC BLOCK (UP. PRESS SERIES AND UP. CAD SERIES)EIH2014-12-18
1955621014247150K141724UPCERA DENTAL ZIRCONIA BLANK & DENTAL ZIRCONIA PRE-SHADED BLANKEIH2014-10-22
1142031757698385K141724UPCERA DENTAL ZIRCONIA BLANK & DENTAL ZIRCONIA PRE-SHADED BLANKEIH2014-10-22
1142031021299525K141723UPCERA COLORING LIQUID (I AND II )EIH2014-10-22
1955621682585962K141723UPCERA COLORING LIQUID (I AND II )EIH2014-10-22
1171731852835746K140211ULTRASONIC MESH NEBULIZERCAF2014-05-30
1171731057258629K132247ULTRASONIC MESH NEBULIZERCAF2014-01-08
1049791523016584K121243
1171731966464261K121154ULTRASONIC NEBULIZERCAF2012-08-20
232711938233552K112110STERILE LUBRICATING JELLYKMJ2012-04-10
1171731679325312K110721GAUNYING INFRARED LAMPILY2011-03-30
1171731000991401K101693GAUNYING INFRARED LAMP MODEL IL50ILY2011-01-05
1049791331210726K100439MEDIWORKS SLIT LAMPHJO2010-07-16
1635311920164337K082815WELL LEAD SILICONE AND LATEX FOLEY CATHETERSEZL2008-10-08
1049791440860140K05259966 VISION TECH OPHTHALMOSCOPE, MODELS YZ6E, YZ6F, YZ6G, YZ11, YZ11C, YZ11D, YZ25AHLJ2006-11-07
1965991829896208K033076LIFESTYLES LIQUID PERSONAL LUBRICANTHIS2003-12-19
914471160147484
914471449526409
914471543959474
232711007411991
232711008633150
232711015879568
2924371021232413
1049791022807662
2761871028230558
232711032225042
232711032524884
232711035519179
232711036027429
914471043145485
232711043863586
1635311044250370
232711044888057
260331047614327
232711047715681
232711048428869
232711055270797
2848171061159519
232711065478070
232711066463582
1830081067105256
1559541080021032
232711084927291
232711085928506
2848171094255599
1768241094323801
1453041097208560
2848171103510562
2848171103544221
232711104491386
1950181105074547
2761871113335987
914471117536521
1559541118080131
232711122850340
1965991129194070
226341129564778
232711131339640
232711131766508
1559541134447049
232711135224796
232711135363755
2761871138320319
1049791140967182
2848171143461915
1049791144466087
1049791147061927
1049791147887413
1559541152504149
1288641152606800
1635311155444697
1950181157279987
232711169421724
1635311174830682
232711176376599
1950181182472275
232711186016539
1635311186146832
1950181187715742
1635311187970843
1453041190622731
232711192418766
232711192778865
1768241196505452
3495631203629609
260331206640478
914471210592491
232711212451157
1768241215897385

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
EIH142026-01-09
FRO72024-01-11
CAF32014-05-30
EBG22026-03-02
NUH22024-03-25
EBF22017-01-12
ILY22011-03-30
OHS12025-08-07
KLE12024-10-02
NUC12021-05-18
HKI12020-01-22
FLL12018-11-28
HKY12016-04-15
EZD12016-03-03
IYO12015-11-17
KMJ12012-04-10
HJO12010-07-16
EZL12008-10-08
HLJ12006-11-07
HIS12003-12-19