FDA.reportPublic FDA data

BIOMERICS

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10571961000140478Biomerics Mebane1N2026-01-011405 Dogwood Way Mebane NC US 27302
16468311000160215BIOMERICS FMI1N2026-01-011605/1704/1700 Enterprise St. Athens TX US 75751
10001652861000165286Biomerics Winston-Salem1N2026-01-012701 Boulder Park Ct Winston Salem NC US 27101
30036785433003678543Biomerics Alajuela1N2026-01-01SARET INDUSTRIAL PARK BLDG. D-3, C-1, C-7, C-2/C-3, C-4, E-2 ALAJUELA CR 4002
30089982563008998256BIOMERICS1N2026-01-016030 W Harold Gatty Drive Salt Lake City UT US 84116
30121591653012159165BIOMERICS Advanced Catheter1N2026-01-0110351 Xylon Avenue N Brooklyn Park MN US 55445
30142466393014246639Biomerics Cartago1N2026-01-01Edificio 22-23 A to D and A4 Zona Franca Parque Industrial Zeta Cartago CR 30106
30160797563016079756Biomerics NLE1N2026-01-01246 Main St Monroe CT US 06468
30263909913026390991Biomerics Dominican Republic1N2026-01-01Carretera Sanchez KM 18.5, Parque Insutrial Itabo Haina San Cristobal DO 91000
18331171833117Biomerics ATL, LLC1N2020-04-256102 Victory Way INDIANAPOLIS IN US 46278

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
B452NIM05010BB0Nimbus Electrosurgical Radiofrequency Multitined Expandable Electrode - NIM05010BB8013552705csr@biomerics.com
B452NIM05010BB1Nimbus Electrosurgical Radiofrequency Multitined Expandable Electrode - NIM05010BB8013552705csr@biomerics.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
335261801027862K990387ENDOMETRIAL SAMPLERHHK1999-04-20
335261813451824K974357UTERINE MANIPULATOR/INJECTORLKF1998-02-02
335261393251428K946044DISPOSABLE GAS SAMPLING LINESCCK1994-12-27
2140941393251428K946044DISPOSABLE GAS SAMPLING LINESCCK1994-12-27
335261247888365K914337GAS SAMPLING INTERFACESCCK1992-03-11
2140941247888365K914337GAS SAMPLING INTERFACESCCK1992-03-11
335261045375749K882329L-F COILED EXTENSION TUBINGDXT1988-09-02
2140941045375749K882329L-F COILED EXTENSION TUBINGDXT1988-09-02
1879581144706966K221390BNLE Access GuidewireDQX2023-04-28
1484581167143075K191538Resectr Tissue Resection DeviceHIH2020-01-16
1484581855909851K182443Pristine Hemodialysis CatheterMSD2019-05-31
1484582038065327K1819045 FR Dual Lumen Piper PICCLJS2018-09-25
1484581103810524K181208Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL CatheterPND2018-11-02
1484581837645293K173956Biowy PlCC CatheterLJS2018-05-21
1484581427399476K172899Vygon PICCsLJS2018-02-26
335261033859720K172299Accordion Piccolo Stone Management DeviceFFL2017-09-19
1879581353612562K162925AcQGuide Steerable SheathDRA2017-04-06
335261194033413K162075NICO TRIOwandGEI2016-08-11
335261369458474K160942SonablatePLP2016-12-21
1484581721627082K142347Amedica Valeo II Interbody Fusion DeviceMAX2014-11-18
1484581578049785K142229Laparoscopic FMsealerGEI2015-01-02
335261339733183K141666FERTILIGENT SLOW RELEASE IUI CATHETER KITMQF2015-02-03
1484581876196859K141484OPEN FMSEALERGEI2014-07-30
1484581253766021K130873VWING VASCULAR NEEDLE GUIDE, 4MM X 07MM; VWING VASCULAR NEEDLE GUIDE, 6MM X 07MM; VWING VASCULAR NEEDLE GUIDE, 8MM X 07MPFH2013-09-13
335261835662937K130736BLOM-SINGER ADJUSTABLE BI-FIANGED FISTULA PROSTHESISLRC2013-12-17
335261224632670K123258THE ADVANCE CATHETER FOR HSG AND SISLKF2013-01-31
335261319846260K120154INTRAUTERINE INSEMINATION (IUI) CATHETERMQF2012-03-21
1484581063649912K110439DOMAIN SURGICAL SYSTEMGEI2011-07-18
335261270607638K102887ACCORDION STONE MANAGEMENT DEVICE MODEL AC281205 AND AC3814510FFL2011-05-16
335261182093056K090785MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 865214MWI2009-12-15
335261160543474K082803COAXIAL ACCORDION STONE MANAGEMENT DEVICE, MODEL: COAC12005 - COA20015FFL2008-11-13
335261886527731K042744OPTIV ANTAGE DH POWER INJECTION SYSTEMDXT2004-11-30
335261985849556K042290VACUUM ASSISTED CORE BIOPSY DEVICEKNW2004-10-06
1484581445920703K033028ANEFIN, MODEL 100CBN2005-07-22
335261704846334K032835H/S CATHETER SETLKF2003-12-11
335261116283627K022593THOMAS MEDICAL ELECTRODESHGI2002-11-01
335261138819041K020292UTERINE INJECTORLKF2002-04-17
335261638372636DEN150011Sonablate 450PLP2015-10-09
1070471145664511
1879581193624784
335261213245071
814941226703412
1070471260636513
1484581381425365
1879581454201662
1879581484270163
814941557450649
335261649068606
335261708106819
1262441742582094
335261776641138
335261898188128
335261919464248
335261924960400
1879582008212776
1879582032961185
814941006935659
3235741010083141
3235741014188758
3235741017775633
1879581038163713
2140941045375749
814941078853344
1484581080698892
3235741080978863
1484581081075037
2140941082131529
3235741085292412
814941092115616
3235741094057781
3235741102572203
1484581104092854
1484581106539308
3235741124105334
814941133817195
1484581137229133
814941138549289
2140941145343709
2140941153141840
1484581156065671
1879581178990378
2140941192182881
3235741203656284
3235741212784110
1484581215031201
2140941217168644
814941217175465
1484581220023159
814941229008529
3235741247102964
814941249583667
1484581265185468
3235741265338976
3235741266923774
814941270864599
814941273089930
3235741273157196
814941280341840
1484581293123235
3235741304430070
2140941307566224
1484581308395146
3142131318153099
3235741319432958
3235741328922213
814941329006896
3235741336558951
1484581346904928
3235741350164759
3235741359972279
814941372723531
3235741395106858
3235741401042050
1879581411909970
1484581422601570
2140941436759868
814941441029321
3235741455136505
2140941460689854
2140941489121598

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GEI42016-08-11
LKF42013-01-31
CCK41994-12-27
LJS32018-09-25
FFL32017-09-19
DXT32004-11-30
PLP22016-12-21
MQF22015-02-03
DQX12023-04-28
HIH12020-01-16
MSD12019-05-31
PND12018-11-02
DRA12017-04-06
MAX12014-11-18
LRC12013-12-17
PFH12013-09-13
MWI12009-12-15
CBN12005-07-22
KNW12004-10-06
HGI12002-11-01
HHK11999-04-20

PMN#

GUDID#