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
30045764023004576402Mirari Japan Co. Ltd.1N2026-01-01Presso DHL Pro-Logis Park Narita 1-B 0113 Narita-shi Chiba Tokyo JP 286
30053695403005369540MIRAVISTA DIAGNOSTICS1N2026-01-014705 Decatur Boulevard Indianapolis IN US 46241
30069438463006943846MIRACLE MEDICAL INDUSTRIES1N2026-01-01104 Industrial Zone (B-C) El Obour City Al Qahirah EG 11846
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
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
1819161522810449K210825Revitive Medic Coach (Model Number 5575AQ)NGX2021-12-17
2393331970793626K182016Simplicit90YLLZ2018-12-06
2393331334296545K181572Workflow BoxQKB2018-07-10
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
2359771808028375K160141miraDry SystemNEY2016-10-31
2957772018630306K160141miraDry SystemNEY2016-10-31
2359771270498604K150419miraDry System MD4000OUB2015-06-19
2957771424514808K150419miraDry System MD4000OUB2015-06-19
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
2393331850793143K130393MIRADA RTXLLZ2013-03-20
1878831268985333K122575BAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS, BAUSCH & LOMB PUREVISION TORIC (BALAFILCON A) VILPL2012-12-20
1878831890531821K113703BAUSCH + LOMB NESOFILCON A CONTACT LENSLPL2012-06-05
1356721934555056K112591SAFE SECURE STERILIZATION POUNCH WITH STEAM AND ETHYLENE OXIDE PROCESS INDICATORSFRG2012-02-07
1356721676991415K110776DIGITAL THERMOMETER MT SERIESFLL2011-08-24
2393331576068806K102687MIRADA RTLLZ2010-10-04
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
2393331199680203K033955RTISTLLZ2004-03-17
1356721705960264K030712AMSURE URETHRAL CATHETERIZATION TRAYFCM2003-05-23
1356721109355562K030664AMSURE FOLEY INSERTION TRAYFCM2003-05-23
1356721250238512K030664AMSURE FOLEY INSERTION TRAYFCM2003-05-23
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
906411008790454
906411017865368
2831561023069660
3415431033077365
2831561033079232
906411044288751
906411063175407
1819161071496685
906411080282970
906411095385227
906411106293806
906411112196973
906411142178656
906411167972730
906411168273625
3445161170946640
906411173007252
906411183905174
906411186957760
906411191525976
906411200977174
2049291213211786
906411213326367
906411216596370
906411217913062
906411229541973
906411244371688
906411246500200
1826301266908942
906411286714279

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LPL122016-07-13
LLZ62018-12-06
NEY42018-03-15
OUB42015-06-19
FCM32003-05-23
FLL22011-08-24
HIB22010-02-16
FXX22008-08-11
NGX12021-12-17
QKB12018-07-10
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#

CUREFINI

Miramar Cosmetics, Inc DBA Miramar Lab

Petrolatum, Cod Liver Oil

CUREFINI

Miramar Cosmetics, Inc DBA Miramar Lab

Petrolatum

Mamisan

Miramar Cosmetics, Inc DBA Miramar Lab

Lidocaine Hydrochloride, Menthol

KRAZATI

Mirati Therapeutics, Inc

adagrasib

PMA#

TS2000

1999-11-15

MIRABEL MEDICAL SYSTEMS, INC.

PMN#

XD

2022-04-15

Mirada Medical Ltd

RTIST

2004-03-17

MIRADA SOLUTIONS LTD.

SURE BOND

1999-11-29

MIRADENT DISTRIBUTING CO., LLC.

138 records. Showing 1-40. Next

Applications#

216340

MIRATI THERAPEUTICS, INC

GUDID#

99 records. Showing 1-40. Next