FDA.reportPublic FDA data

MIRA, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
12188131218813MIRA, INC.1N2026-01-01414 Quaker Hwy UXBRIDGE MA US 01569
15291021000160007Mirac, LLC1N2026-01-01316 Main St Lynchburg OH US 45142
20853211000306436MIRAGE EYEWEAR, INC.1Y2026-01-013361 POMONA BLVD Pomona CA US 91768
80210333006218263MIRAGE S.r.l.1N2026-01-01Via Giulio Cesare 39 VENEGONO SUPERIORE Varese IT 21040
96805771000366600Miranda Deverall1N2026-01-017 Loveton Circle Sparks MD US 21152
30053695403005369540MIRAVISTA DIAGNOSTICS1N2026-01-014705 Decatur Boulevard Indianapolis IN US 46241
30069438463006943846MIRACLE MEDICAL INDUSTRIES1N2026-01-01104 Industrial Zone (B-C) El Obour City Al Q?hirah EG 11846
30069488833006948883Miranda Deverall1N2026-01-017 Loveton Circle Sparks MD US 21152
30076979583007697958MIRADA MEDICAL LIMITED1N2026-01-01New Barclay House 234 Botley Road Oxford (UK) Oxfordshire GB OX2 0HP
30080827103008082710miraDry, Inc.1N2026-01-01721 Charcot Ave San Jose CA US 95131
30085722033008572203MIRACLEAN TECHNOLOGY CO., LTD.1N2026-01-01Room 101, Building 1, Angeer Factory, No.4, Hetian Road, Shatian Shenzhen City Guangdong CN 518122
30093491653009349165MIRA MEDSOURCE (SHANGHAI) CO., LTD.1N2026-01-01UnitA, 23F, HuaXinHaiXin Building 666 FuZhou Road, Huangpu District Shanghai CN 200001
30096739703009673970MIRAE WELL LIFE CO.,LTD1N2026-01-01515-12 Dongan-Ro Chaeun-Myeon Nonsan KR 32946
30115621293011562129MIRAE MEDI&TECH CO., LTD.1N2026-01-0122, Baekseokgongdan 5-gil, Seobuk-gu Cheonan-si Chungnam KR 331-979
30115643213011564321MIRACLEFEET1N2026-01-01107 CONNER DR STE 230 CHAPEL HILL NC US 27514
30151959703015195970MIRACLE MOBILITY LLC1Y2026-01-0113575 58th St N No. 201 Clearwater FL US 33760
30187182163018718216MIRACLE IMPORT EXPOR INC1Y2026-01-01228 PARK AVE S 79525 New York NY US 10003
30346037093034603709MIRABAY ORTHODONTICS CORPORATION1N2026-01-012108 N ST STE N Sacramento CA US 95816
30421569343042156934MIRAZO CO.,LTD.1N2026-01-01168/2 Moo 8, Bowin Subdistrict, Sriracha District, Chonburi Thailand Chon Buri TH 20230
30040833823004083382MIRAFLEX S.A.S.1N2020-04-25Calle 76 B # 20B - 24 BOGOTA Distrito Capital de Bogota CO --
30045064923004506492MIRAFLEX1Y2020-04-257950 NW 53rd St Ste 324 Doral FL US 33166
30080827103008082710miraDry, Inc.1Y2020-04-252790 Walsh Ave Santa Clara CA US 95051
30087414363008741436MIRABILIS MEDICA, INC.1N2020-04-2518706 North Creek Parkway, Suite 104 Bothell WA US 98011
30116124663011612466MIRAR LABORATORIES PTE LTD1N2020-04-251 Clementi Loop, 05-01 singapore Central Singapore SG 129808
30166487063016648706Mirada Medical USA Inc1Y2020-04-251630 Welton Street Suite 200 D Denver CO US 80202

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
10850510007016MIRA IMEX Scleral Buckling Component - Strip 4mm5082787877customerservice@mirainc.us
10850510007030MIRA IMEX Scleral Buckling Component - Circling Band 2mm5082787877customerservice@mirainc.us
10850510007047MIRA IMEX Scleral Buckling Component - Strip 3.5mm5082787877customerservice@mirainc.us
10850510007054MIRA IMEX Scleral Buckling Component - Strip 4mm5082787877customerservice@mirainc.us
10850510007061MIRA IMEX Scleral Buckling Component - Double Tantalum Clip 2mm5082787877customerservice@mirainc.us
10850510007092MIRA IMEX Scleral Buckling Component - Ross Sleeve 2.25mm I.D.5082787877customerservice@mirainc.us
10850510007108MIRA IMEX Scleral Buckling Component - Meridional Implant 6x10.5mm5082787877customerservice@mirainc.us
10850510007115MIRA IMEX Scleral Buckling Component - Strip 4.5mm5082787877customerservice@mirainc.us

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1878832058266811P040045VISTAKON (SENOFILCON A) CONTACT LENS, CLEAR AND VISIBILITY TINTED WITH UV BLOCKERLPM2005-12-20
300241395806547K950806SOLID DILICONE IMPLANTS, SDILICONE SPONGE IMPLANTSHQX1996-06-05
300241432727548K923629OPHTHALMIC TRICHIASIS PROBEHPS1992-10-19
1356722038888263K780715ANEROID TYPE BLOOD PRESSURE KITDXQ1978-07-17
300241419925527K760686CRYOLYZER ALPHA (CRYOSURG.EQUIP.)GEH1976-11-01
300241452478800K760550IMPLANT, SILICONE AND TANTALUMHQJ1976-10-05
1088001807442318K243872BD Veritor System for SARS-CoV-2QVF2025-06-16
1088001691251687K232434BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived KitPSZ2023-12-05
1088001511920441K223016BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived KitPSZ2023-01-27
1011441137169212K220779XDLLZ2022-04-15
1819161522810449K210825Revitive Medic Coach (Model Number 5575AQ)NGX2021-12-17
1011441065469970K202297Aline Ablation IntelligenceLLZ2020-09-11
1011441970793626K182016Simplicit90YLLZ2018-12-06
2393331970793626K182016Simplicit90YLLZ2018-12-06
1011441334296545K181572Workflow BoxQKB2018-07-10
2393331334296545K181572Workflow BoxQKB2018-07-10
1088001900146479K180438BD Veritor System for Rapid Detection of Flu A + B CLIA waived kitPSZ2018-03-20
2359771580879776K180396miraDry SystemNEY2018-03-15
2957771976774778K180396miraDry SystemNEY2018-03-15
1878831757463659K160803Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact LensLPL2016-07-13
1878831214847071K160212ACUVUE (senofilcon C) Soft Contact LensLPL2016-03-28
1088001989325693K160164BD Veritor System for Rapid Detection of Flu A + B Labratory KitPSZ2016-02-25
1088001194426074K160161BD Veritor System for Rapid Detection of Flu A + B CLIA waived kitPSZ2016-02-24
2359771808028375K160141miraDry SystemNEY2016-10-31
2957772018630306K160141miraDry SystemNEY2016-10-31
1088001378584085K152874BD Veritor System for the Rapid Detection of Flu A + B Laboratory kitPSZ2015-10-27
1088001851776484K152870BD Veritor System for the Rapid Detection of Flu A + B CLIA waived kitPSZ2015-10-27
1088001858037241K151301BD Veritor™ System Flu A+B AssayPSZ2015-06-08
1088001853834457K151291BD Veritor (TM) System for the Rapid Detection of Flu A+BPSZ2015-06-10
2359771270498604K150419miraDry System MD4000OUB2015-06-19
2957771424514808K150419miraDry System MD4000OUB2015-06-19
1088001846496468K133140BD VERITOR SYSTEM FOR THE RAPID DETECTION OF RSVGQG2013-11-15
1088001311611267K133138BD Veritor™ System Flu A+B AssayPSZ2013-11-13
1088001130643749K132693BD Veritor™ System Flu A+B AssayPSZ2013-10-02
1088001442309733K132692BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+BPSZ2013-09-23
1088001018721514K132456BD VERITOR (TM) SYSTEM FOR RAPID DETECTION OF RSVGQG2013-11-07
1088001632951219K132259BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+BPSZ2013-08-07
1088001375844701K132256BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+BPSZ2013-08-07
1878831848802092K131208BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS, BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS FOR PRESBYOPIA,LPL2013-09-11
2359771425728618K131162MIRADRY SYSTEMOUB2013-10-25
2957771610390023K131162MIRADRY SYSTEMOUB2013-10-25
1011441850793143K130393MIRADA RTXLLZ2013-03-20
2393331850793143K130393MIRADA RTXLLZ2013-03-20
1088001492842405K122718BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF GROUP A STREPGTY2013-02-06
1878831268985333K122575BAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS, BAUSCH & LOMB PUREVISION TORIC (BALAFILCON A) VILPL2012-12-20
1088001892941324K121797BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF FLU A+BPSZ2012-09-07
1088001028857861K121633BD VERITOR(TM) SYSTEM FOR THE RAPID DETECTION OF RSVGQG2012-09-18
1088001468664831K120049BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+BPSZ2012-03-23
1878831890531821K113703BAUSCH + LOMB NESOFILCON A CONTACT LENSLPL2012-06-05
1356721934555056K112591SAFE SECURE STERILIZATION POUNCH WITH STEAM AND ETHYLENE OXIDE PROCESS INDICATORSFRG2012-02-07
1088001962144413K112277BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF FLU A+BPSZ2011-10-28
1356721676991415K110776DIGITAL THERMOMETER MT SERIESFLL2011-08-24
1011441576068806K102687MIRADA RTLLZ2010-10-04
2393331576068806K102687MIRADA RTLLZ2010-10-04
1011441395554937K101228MIRADA XDLLZ2010-06-23
2393331395554937K101228MIRADA XDLLZ2010-06-23
1356721740312184K092870NON-STERILE DISPOSABLE VAGINAL SPECULUMHIB2010-02-16
1878831748818793K091339BIOMEDICS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENSLPL2010-01-05
1356721506043784K081633PRIMAGARD 80, 120, 160 FLUID RESISTANT PROCEDURE/SURGICAL FACE MASKSFXX2008-08-11
1878831585869970K073485VISTAKON (NARAFILCON) A SOFT CONTACT LENSLPL2008-03-03
1356721348656937K062784SEJOY DIGITAL THERMOMETER, MT SERIES (MT-201, MT-301, MT-402, MT-403 AND MT-405)FLL2007-05-04
1878831596118894K062614VISTAKON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, CLEAR AND TINTED (VISIBILITY AND/OR COSMETICALLY)LPL2006-11-01
1878832004307634K061948PROCLEAR (OMAFILCON A) DAILY DISPOSABLE/DAILY WEAR SOFT CONTACT LENSMVN2006-11-22
1356721428089712K061039AMSURE DISPOSABLE SYRINGE WITH/WITHOUT NEEDLEFMF2006-06-29
1878831892724954K052560BIOFINITY (COMFILCON A) SOFT CONTACT LENSLPL2005-12-06
1356721003976359K050887GONGDONG DISPOSABLE VAGINAL SPECULUMHIB2005-07-11
1878831389108255K042275VISTAKON (SENOFILCON A) SOFT CONTACT LENSLPL2004-10-28
1011441199680203K033955RTISTLLZ2004-03-17
2393331199680203K033955RTISTLLZ2004-03-17
1356721705960264K030712AMSURE URETHRAL CATHETERIZATION TRAYFCM2003-05-23
1356721109355562K030664AMSURE FOLEY INSERTION TRAYFCM2003-05-23
1356721250238512K030664AMSURE FOLEY INSERTION TRAYFCM2003-05-23
1088001165410206K022133BD DIRECTIGEN EZ RSV KITGQG2002-12-10
1011441822878973K020546FUSION 7DLLZ2002-04-26
2393331822878973K020546FUSION 7DLLZ2002-04-26
1878832005808710K013973ACUVUE BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES; CLEAR AND TINTED (VISIBILITY AND/OR COSMETIC) WITH UV BLOCLPL2002-02-26
1356721890532092K001951PRIMED PLEATED TIE-BACK, PROCEDURE MASK PM4-305, PRIMED PLEATED EAR-LOOP, PROCEDURE MASK PM4-306FXX2000-09-08
1878831876225347K000384FREQUENCY 55, FREQUENCY 55 ASPHERIC, ENCORE, ENCORE TORIC, ONEVIEW, COOPERFLEXLPL2000-03-06
1356721000587366
1356721001048227
1356721013922831
1356721039412997
1356721065579485
1356721076804956
1356721108096254
1356721172741780
1356721176427890
1356721200369154
1356721242104795
1356721242391318
1356721249473755
1356721311577729
620171322497417
1356721329751254
1356721411125404
1356721427044151
1356721428187626
1356721450391182
2110641560828473
1356721571681166
1356721614757945
1356721638922575
1356721643402947
1356721660469358
1356721703302810
1356721722298869
2393331760547593
1356721768347225
1356721774299087
1356721781086273
1356721802180531
1356721814696754
2049291852078985
1356721857895155
1356721875988607
1356721897452128
1356721929641812
1356722012443901
1356722053202798
1356722055260844

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
PSZ172023-12-05
LLZ142022-04-15
LPL122016-07-13
NEY42018-03-15
OUB42015-06-19
GQG42013-11-15
FCM32003-05-23
QKB22018-07-10
FLL22011-08-24
HIB22010-02-16
FXX22008-08-11
QVF12025-06-16
NGX12021-12-17
GTY12013-02-06
FRG12012-02-07
MVN12006-11-22
FMF12006-06-29
LPM12005-12-20
HQX11996-06-05
HPS11992-10-19
DXQ11978-07-17
GEH11976-11-01
HQJ11976-10-05

NDC#

PMA#

PMN#

138 records. Showing 1-40. Next

Applications#

GUDID#

99 records. Showing 1-40. Next