FDA.reportPublic FDA data

Dar

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
11228451000123428DARCO INTERNATIONAL, INC.1Y2026-01-01810 Memorial Blvd W HUNTINGTON WV US 25701
23209823003335667DARBY DENTAL SUPPLY LLC1Y2026-01-014460 E HOLMES RD. Mem TN US 38118
29549343003325181DARBY DENTAL SUPLLY LLC1Y2026-01-014745 Longley Ln Reno NV US 89502
96150193003751850Darlene Hawthorne1N2026-01-0114221 29th St E # 1 Sumner WA US 98390
96802843002809016DARLA ELGIN1N2026-01-013M Company , 2510 Conway Ave. Saint Paul MN US 55144
10005890011000589001Darren DeMerritt1N2026-01-012000 Center Drive Suite D403 Hoffman Estates IL US 60192
10006552111000655211Darshan Bhaiya1N2026-01-01250 Commercial Street, Suite 3007 Manchester NH US 03101
30012975063001297506DARLEYS SURGICAL CO.1N2026-01-012-A KUTCHERY RD. SIALKOT, PUNJAB PK 51310
30028063953002806395Darren Demerritt1N2026-01-012000 Center Drive Suite D403 Hoffman Estates IL US 60192
30034598433003459843DARBY DENTAL SUPPLY LLC1Y2026-01-01NE INDUS. PARK, VAN BUREN BLVD BUILDING 27 GUILDERLAND CENTER NY US 12085
30037715703003771570Daryl Wisdahl1N2026-01-0110900 Research Blvd Ste 160c Austin TX US 78759
30051285833005128583Dariusz Sury1N2026-01-01420 Bennett Road Elk Grove Village IL US 60007
30056199703005619970Darren Demerritt1N2026-01-012000 Center Drive Suite D403 Hoffman Estates IL US 60192
30059900763005990076Darrall Pride1N2026-01-01100 CUMMINGS CENTER Ste 136L BEVERLY MA US 01915
30060261113006026111DARCO (Europe) GmbH1N2026-01-01GEWERBEGEBEIT 18 RAISTING Bavaria DE D-82399
30065808613006580861DARLA ELGIN1N2026-01-013M Company, 2510 Conway Ave. Saint Paul MN US 55144
30074206943007420694Darren Demerritt1N2026-01-012000 Center Drive D403 Hoffman Estates IL US 60192
30085129353008512935DARLA ELGIN1N2026-01-013M Company, 2510 Conway Ave. Saint Paul MN US 55144
30096996113009699611DARLA ELGIN1N2026-01-013M Company , 2510 Conway Ave. Saint Paul MN US 55144
30097013083009701308Daryl Wisdahl1N2026-01-0110900 Research Blvd Ste 160c Austin TX US 78759
30122516553012251655DarioHealth Corp.1Y2026-01-01322 W. 57th Street #33B New York NY US 10019
30129861173012986117DARCO INTERNATIONAL CORPORATION1Y2026-01-01510 Shotgun Road, Ste, 520 Sunrise FL US 33326
30135265013013526501Daryl Wisdahl1N2026-01-0110900 Research Blvd Ste 160c Austin TX US 78759
30135848243013584824Dario Taddeo1N2026-01-018 The Grn Ste B Dover DE US 19901
30142718973014271897Daryl Wisdahl1N2026-01-0110900 Research Blvd Ste 160c Austin TX US 78759

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
398741910422956K984307MODIFICATION OF: RHEO DOPPLEX IIIYN1999-01-12
963411062713732K965153HUNTLEIGH FP5000 SYSTEM MODEL FP5000JOW1998-01-26
398741298998552K964699RHEO DOPPLEX II (RD 2)IYN1997-02-21
963411927293912K961166FLOWTRON EXCEL PUMPJOW1996-10-11
963491927293912K961166FLOWTRON EXCEL PUMPJOW1996-10-11
963411899053915K952442FREEDOM BATHILJ1995-11-02
398741160771434K930714SONICAID MODEL TEAM FECG IUPHEL1995-08-24
963411872153588K930665CENTURY BATHING SYSTEMILJ1995-08-28
398741632425811K930200MULTI DOPPLEX II / FETAL DOPPLEX IIKNG1994-06-24
963411523068562K925717CALF GARMENT DVT10(S) COMPRESSIBLE LIMB SLEEVEJOW1993-05-07
398741137238142K924516OP3/VP4HGL1993-06-28
398741905287153K912639SONICAID TEAMHGM1991-12-31
398741069170566K910188FLOWPLUS AC330 PUMP GARMENTSJOW1991-05-28
57151070361003K9101823M BRAND EAR LOOP FACE MASK, 2000FFXX1991-03-04
398741191130979K900618HUNTLEIGH FETAL DOPPLER, FD-1 & DOPCORD, D140KNG1990-04-25
57151873540991K832318ISOLATION BAG 3MKGY1983-10-31
57151884034085K8015503M GERMICIDAL SURGICAL INCISE DRAPEKKX1981-09-17
398741535011913K250777Sonicaid Team3HGM2025-09-19
398741332586815K241368Sonicaid Team3HGM2025-02-03
398741980892585K211200WoundExpressJOW2021-09-03
168411674444044K201807ANCORISKPS2020-08-27
398741480190687K201425Disposable Intraoperative Probe (DIOP8)ITX2021-02-19
398742060095070K200975Sonicaid Team3 Antepartum, Sonicaid Team3 IntrapartumHGM2020-06-24
398741126942363K183574SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular ProbesDPW2019-09-06
1226561458361499K181721Ceracell Ortho FoamMQV2018-09-17
963411316043918K172103Flowtron DVT5 Small Calf GarmentJOW2018-03-02
963491316043918K172103Flowtron DVT5 Small Calf GarmentJOW2018-03-02
1226561787691595K160566Cerasorb Ortho FoamMQV2016-12-02
398742063941364K152228Hydroven 12, Hydroven 12 GarmentsJOW2016-04-04
963411158207603K143438Flowtron ACS900JOW2015-06-23
963491158207603K143438Flowtron ACS900JOW2015-06-23
963411932310651K133119FLOWTRON ACS800 PUMP AND TRI PULSE GARMENTSJOW2014-02-28
963491932310651K133119FLOWTRON ACS800 PUMP AND TRI PULSE GARMENTSJOW2014-02-28
398741521581148K132650SONICAID FREEDOM WIRELESS FETAL MONITORING SYSTEMHGM2014-02-07
168411253555912K130269ECAT SCINTRON PETKPS2013-04-19
963411118047518K122330FLOWTRON FOOT GARMENT-REGULAR-STERILE FLOWTRON FOOT GARMENT-LARGE-STERILEJOW2012-12-07
398741345925663K121108DOPPLEX ABILITYJOM2013-01-03
1452481321450509K120976MANUKA IGFRO2012-05-23
2016091321450509K120976MANUKA IGFRO2012-05-23
1226561146403835K111105CURASAN OSSEOLIVE DENTALLYC2012-12-20
963411589505546K110994PARKER 500ILJ2011-07-06
1226561568292081K103709CERACELL DENTALLYC2011-03-10
1226561800765705K102872OSBONE DENTALLYC2011-01-12
168411903251882K101768MIE SCINTRON GAMMA CAMERA SYSTEMSKPS2010-10-05
1625831476716341K1015283M COMPLY LEAD FREE PROCESS INDICATORS FOR STEAMJOJ2010-10-01
168411926104357K101013MODIFICATION TO SCINTRON IVKPS2010-06-07
398741174783375K090285SONICAID FM820 AND FM830 ENCOREHGM2009-07-15
398741218946250K081572SMARTSIGNS MINPULSEDQA2008-10-01
121121299660789K062873SUNPOLAR HEALTHLINE, MODEL 100; COMPFRESH, MODEL 200; NATUREX , MODEL 300; AND IHEALTH, MODEL 400 STOCKINGSDWL2007-03-20
57151667645066K060865BAIR PAWS TEMPERATURE MANAGEMENT SYSTEM MODEL 850DWJ2006-04-24
398741976967575K060230DOPPLEX CENTRALEHGM2006-03-23
168411301466187K053086MIE - GAMMA CAMERA SYSTEMSKPS2006-01-27
1226561056287352K051443CERASORB DENTAL, CERASORB M DENTAL AND CERASORB PERIOLYC2005-07-22
1226561524880340K040216CERASORB M ORTHOMQV2004-03-26
398741502571084K032315IOP8 INTRA OPERATIVE PROBEITX2004-11-18
398741813901465K023618SONICAID ONEHGM2003-01-22
963411831323072K022786DVT60JOW2002-09-19
398741573185647K010894BABY DOPPLEX 3002 (BD3002)HGM2001-04-25
963411429392216K010744FLOWTRON UNIVERSAL, MODEL AC600JOW2002-03-26
963491429392216K010744FLOWTRON UNIVERSAL, MODEL AC600JOW2002-03-26
398741069239443K002186VASCULAR ASSISTDPW2001-05-02
398741207604038K001882BABY DOPPLEX 4002-TWINS, MODEL BD4002HGM2000-09-19
963411101691949K001079RECUMBENT BATHING SYSTEMS, RHAPSODY AND PRIMOILJ2000-05-01
121121062748741
57151074524716
178421081763326
1289151088222021
121121144957941
1289151167674181
178421208464072
178421224126580
57151224444792
178421256693118
178421292948968
57151388882858
178421405798777
178421415696161
121121431266608
178421456245850
178421460314997
57151473948854
121121489407776
178421511469947
178421532956825
178421554118443
178421610622850
178421626334627
178421630215394
178421630362732
121121650599531
178421679077127
178421697130351
178421700118728
263741700905025
431221722968703
178421725595823
57151760487117
1289151760487117
178421767330862
168411772457484
57151779981685
57151784113049
57151801817907
121121817657013
178421837441382
57151878981449
57151910734057
431221939089254
178421960408006
178421974799310
263741976815455
178422017497374
431222034182967
178422035337976
57151005779574
178421007266582
158991024680043
963411028715692
263741032479392
963411034759972

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JOW172021-09-03
HGM102025-09-19
KPS52020-08-27
LYC42012-12-20
ILJ42011-07-06
MQV32018-09-17
ITX22021-02-19
DPW22019-09-06
FRO22012-05-23
IYN21999-01-12
KNG21994-06-24
JOM12013-01-03
JOJ12010-10-01
DQA12008-10-01
DWL12007-03-20
DWJ12006-04-24
HEL11995-08-24
HGL11993-06-28
FXX11991-03-04
KGY11983-10-31
KKX11981-09-17

NDC#

Lidocaine

Darby Dental Supply, LLC

Lidocaine Hydrochloride and Epinephrine Bitartrate

Lidocaine

Darby Dental Supply, LLC

Lidocaine Hydrochloride and Epinephrine Bitartrate

Mepivacaine

Darby Dental Supply, LLC

Mepivacaine Hydrochloride

PMN#

SAMM

1982-04-14

DART MEDICAL EQUIPMENT

Applications#