FDA.reportPublic FDA data

DIOPSYS INC.

Matched from indexed company URL: DIO CORPORATION

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30041744673004174467DIOPSYS INC.1N2026-01-011000 Kreider Drive STE 700 Middletown PA US 17057
30064001053006400105DIO USA1Y2026-01-011932 E Deere Ave Ste 100 Santa Ana CA US 92705
30071267093007126709DIO Corporation1N2026-01-0166, Centumseo-ro Haeundae-gu Busan KR 48058
30073213673007321367DION LABEL PRINTING, INC.1N2026-01-01539 North Rd Westfield MA US 01085
30114130203011413020DIODE ART ENGINEERING DBA AIR RELAX1Y2026-01-01900 TURNBULL CANYON RD UNIT E04 City Industry CA US 91745
30254889933025488993Dion Snider1N2026-01-0190 Executive Dr Ste E Carmel IN US 46032
20247481000120742Dioptics Medical Products Inc.1Y2020-04-25500 George Washington Highway Smithfield RI US 02917
30041744673004174467DIOPSYS INC.1N2020-04-2516 CHAPIN ROAD SUITE 912 PINE BROOK NJ US 07058
30089585723008958572Dion Wu1N2020-04-254456 BALDWIN AV.EL MONTE, 91731 USA El Monte CA US 91731
30090146373009014637DIO MEDICAL CORPORATION1Y2020-04-252900 Potshop Ln Suite 200 Eagleville PA US 19403
30157818063015781806DIORCO CO., LTD.1N2020-04-25#401, Bong Bldg., 26 Yeongil-ro, Yeongtong 1-dong, Yeongtong-gu Suwon-si Gyeonggido KR 16706

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3375721125206488K241193AGILIS - Multi-function Physical Therapy Table (Model: Plus, Pro and Basic.)JFB2025-01-31
251961657196528K220253Eco Abutment, Multiunit AbutmentNHA2023-08-18
1804251938192267K212491Air Relax Pro Model AR-4.0IRP2021-09-02
1804251501726582K211460Air Relax Plus Model AR-3.0IRP2021-05-25
251961860327887K210828DIOnavi-Denture02EBI2021-03-23
251961465093312K193623DIOnavi-DentureEBI2020-10-22
251961773422108K193404UF(II) Bar holder abutmentNHA2020-05-18
251961044463654K192263UCLA CCM AbutmentNHA2020-02-21
1804251525035636K191441Air Relax, Compressible Limb Sleeve System (Model: AR-1.0, AR-2.0)IRP2021-03-05
251962017656980K190048UF(II) Anatomic abutmentNHA2019-09-30
251962056273328K190048UF(II) Anatomic abutmentNHA2019-09-30
251961758431276K182194UV Active Implant SystemDZE2018-12-14
251961885676500K181037DIO CAD/CAM AbutmentNHA2018-12-21
251961558416223K173975UF(II) Wide FixtureDZE2018-06-01
251961269561539K170608UF(II) Implant SystemDZE2018-03-30
251961256133709K161987UF(II) Narrow Implant System - Fixture, UF(II) Narrow Implant System - SuprastructureDZE2017-02-21
251961625037025K142358Osstell IDxEKX2015-02-19
251961483241319K141570IMPLANT STUDIOLLZ2014-10-31
251961101062664K123695TRAUS SIP10EKY2012-12-18
251961273798707K122519DIO UF HSA INTERNAL SUB-MERGED IMPLANT SYSTEMDZE2013-05-21
251962034690089K112746DIOSLIMON IMPLANT SYSTEMDZE2011-10-21
236411365623913K101763DIOPSYS NOVA VEP VISION TESTING SYSTEMGWE2011-05-09
3426111902780782K101763DIOPSYS NOVA VEP VISION TESTING SYSTEMGWE2011-05-09
251961671188922K100100DIO STEADY EXTERNAL IMPLANT SYSTEMDZE2010-11-10
251961915961237K092758X-CUBEEBW2009-09-21
251961794029710K080559DIO SM IMPLANT SYSTEMDZE2008-10-09
251961560114316K080129SECURE IMPLANT SYSTEM (2.5/3.0MM)DZE2008-05-30
251961631597568K080128SM-EXTRA WIDE (RBM) IMPLANT SYSTEMDZE2008-05-14
251961425241506K080126DIO PROTEM IMPLANT SYSTEMDZE2008-04-11
251961624594962K073070DIO BIOTITE-H IMPLANT SYSTEMDZE2008-05-16
251961084775712K070570DIO IMPLANT SYSTEMDZE2008-04-15
251961185002163K070569SM INTERNAL./EXTERNAL IMPLANT SYSTEMDZE2007-11-08
251961230589491K070568DIO PROTEM IMPLANT SYSTEMDZE2007-05-25
251961534864624K061797SM IMPLANT SYSTEMSDZE2006-09-01
236411044692674K043491ENFANTTMGWE2005-03-16
1573561195296618
2329561331674352
1272201648281509
1272201648551724
1272201666572894
1272201701606051
1272201970597421
251961970774993
251961126336738
1573561184427751
1573561216144549
251961300121032
251961307862474
251961319692987
3375721389069985
3375721397936307
251961419769373
251961539691815
251961553412809
251961579452187
251961966953167
251961977050157
251961996425694

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DZE162018-12-14
NHA62023-08-18
IRP32021-09-02
GWE32011-05-09
EBI22021-03-23
JFB12025-01-31
EKX12015-02-19
LLZ12014-10-31
EKY12012-12-18
EBW12009-09-21

PMN#

67 records. Showing 1-40. Next

GUDID#

200 records. Showing 1-40. Next