FDA.reportPublic FDA data

Jerry Doane

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
Jerry Doane5N2026-01-0115815 SW 11th Court Rd. Ocala FL US 34473
80221663002513507Jerry Doane1N2026-01-0115815 SW 11th Court Rd Ocala FL US 34473
96174441000153304Jerry Doane Doane1N2026-01-0115815 SW 11th Court Rd. Ocala, Florida 34473 Ocala FL US 34473
96803401000434163Jerry Doane1N2026-01-0115815 SW 11th Court Rd Ocala FL US 34473
96814101000339531Jerry Doane1N2026-01-0115815 SW 11th Court Rd Ocala FL US 34473
97105023003321099Jerry Doane1N2026-01-0115815 Sw 11th Court Rd Ocala FL US 34473
30037699533003769953Jerry Doane1N2026-01-0115815 SW 11th Court Rd Ocala FL US 34473
30039190523003919052Jerry Doane1N2026-01-0115815 Sw 11th Court Rd Ocala FL US 34473
30060553873006055387Jerry Doane1N2026-01-0115815 SW 11th Court Rd Ocala FL US 34473
30061578423006157842Jerry Doane1N2026-01-0115815 Sw 11th Court Rd Ocala FL US 34473
30065512303006551230Jerry Doane1N2026-01-0115815 SW 11th Court Rd Ocala FL US 34473
30071206053007120605Jerry Doane1N2026-01-0115815 SW 11th Court Rd Ocala FL US 34473
30080445523008044552Jerry Doane1N2026-01-0115815 SW 11th Court Rd Ocala FL US 34473
30082157233008215723Jerry Doane1N2026-01-0115815 SW 11th Court Rd Ocala FL US 34473
30090775243009077524Jerry Doane1N2026-01-0115815 SW 11th Court Rd Ocala FL US 34473
30096948833009694883Jerry Doane1N2026-01-0115815 SW 11th Court Rd Ocala FL US 34473
30115480113011548011Jerry Doane1N2026-01-0115815 Sw 11th Court Rd Ocala FL US 34473
30118001953011800195Jerry Doane1N2026-01-0115815 SW 11th Court Rd. Ocala FL US 34473
30120849973012084997Jerry Doane1N2026-01-0115815 SW 11th Court Rd Ocala FL US 34473
30131671593013167159Jerry Doane1N2026-01-0115815 SW 11th Court Rd. 34473-8916 Ocala FL US 34473
30132877283013287728Jerry Doane1N2026-01-0115815 SW 11th Court Rd Ocala FL US 34473
30135611393013561139Jerry Doane1N2026-01-0115815 SW 11th Court Rd Ocala FL US 34473
30137011153013701115Jerry Doane1N2026-01-0115815 SW 11th Court Rd Ocala FL US 34473
30161950863016195086Jerry Doane1N2026-01-0115815 SW 11th Court Rd Ocala FL US 34473
30167852683016785268Jerry Doane1N2026-01-0115815 SW 11th Court Rd Ocala FL US 34473

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
558651711510593K994281BIOPRO, NITRILE, CORRECT TOUCH NITRILE POWDER FREE EXAMINATION GLOVES (GRREN, PURPLE)LZA2000-10-20
558651593224850K992021BRIGHTWAY BRAND LATEX SURGICAL GLOVES - STERILE (POWDER FREE)KGO1999-07-23
558651426803910K992020BRIGHTWAY BRAND LATEX SURGICAL GLOVES - STERILE (POWDERED)KGO1999-07-26
558651232983529K991940BRIGHTWAY BRAND NITRILE SURGICAL GLOVES - STERILE (POWDERED)KGO1999-07-12
558651447484119K991939BRIGHTWAY BRAND NITRILE SURGICAL GLOVES - STERILE (POWDER-FREE)KGO1999-07-01
558651632235366K991752BRIGHTWAY BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDERED CONTAINING 150 MLGM OR LESS OF WATER EXTRACTABLE PROTEIN PELYY1999-06-23
558651488939391K991750BRIGHTWAY BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDER FREE CONTAINING 50 MLGM OR LESS OF WATER EXTRACTABLE PROTEINLYY1999-06-23
3063121747113581K991671HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEMIYO1999-06-18
3063121561087045K991366DAUM MRI/CONVENTIONAL BIOPSY KITKNW1999-06-25
558651274509857K990878BRIGHTWAY BRAND BLUE NITRILE EXAMINATION GLOVES (POWDER FREE)LZA1999-05-21
558651862836042K990876BRIGHTWAY BRAND BLUE NITRILE EXAMINATION GLOVES (POWDERED)LZA1999-06-23
558651285978556K990543BRIGHTWAY BRAND POLYMER COATED LATEX EXAMINATION GLOVE (POWDER FREE)LYY1999-04-09
558651488790953K990542BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (LIGHTLY POWDERED)LZA1999-04-09
558651372649600K990541BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (POWDER FREE)LZA1999-04-09
558651925409208K990540BRIGHTWAY BRAND LATEX EXAMINATION GLOVE (LOW PROTEIN)LYY1999-04-09
558651257763544K990539BRIGHTWAY BRAND LATEX EXAMINATION GLOVES (POWDER FREE)LYY1999-04-09
3063121186320847K990339SONOS 5500 IMAGING SYSTEM M2424A VERSION B.OIYN1999-02-18
3063121946999755K983069PHILIPS DUO DIAGNOSTOWB1998-11-02
3063121890299756K981737K-DEFIB/PACE ADULT ELECTRODE MODEL NUMBER KDP-60MKJ1998-12-09
3063121136631940K981320DAUM BONE BIOPSY SETKNW1998-06-29
3063121004695923K974576DAUM BIOPSYGUNKNW1998-03-06
3063121818850420K970640PHILIPS EASY DIAGNOSTIXR1997-03-21
101022021153209K965162LUKENS PGA, (POLYGLYCOLIC ACID) SYNTHETIC ABSORBABLE SURGICAL SUTURE,COATED, BRAIDED-U.S.P.GAM1997-02-12
3063121227847404K963794PUNCTURENEEDLEKNW1998-03-19
3063122013152834K962615TUMORLOCALIZER MRIMIG1998-03-19
3063121154310662K962293ENDOSONICS AUTOMATIC PULL BACK DEVICEITX1996-09-16
3063121605513912K962070YSI 400 SERIES ATUOCLAVABLE REUSABLE TEMPERATURE PROBEFLL1996-07-19
3063121781722659K961366MODEL #QSC-200-4C AND QSC-165-4C ARRAY SHOULDER COILSLNH1996-07-03
3063121243538262K942481FUJI ULTIMA EC-MA CASSETTEIXA1994-07-29
3063121678469666K934396QUADRATURE LOWER EXTREMITY COILLNH1993-11-24
3063122039844030K925910HEWLETT-PACKARD MODEL M1018A TCPO2/TOPCO2 MODULEKLK1993-07-29
2226681924676972K915375ODONTIT OSSEOINTEGRATED IMPLANTS SYSTEMDZE1992-06-03
707102057213493K913749EDENTRACE AIRFLOW 3171/SLEEP LAB AIRFLOW 3170BZQ1992-07-02
101021907043435K900927CODERE-DURETTE ORBITAL FLOOR IMPLANTHQX1990-05-15
3063121783277382K883793DISPOSABLE TEMPERATURE PROBES (SEVERAL MODELS)FLL1988-11-21
3063121405412926K851895POLYGEL ULTRASOUND GELIYO1985-09-27
2061251466080587K221708CIMILRE Free-T2 PlusHGX2022-12-23
3063122024261374K213766dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch Coils for 1.5T and 3.0T, ds Small Extremity 16Ch Coils for 1.5T and 3.0TMOS2021-12-23
3063121343483889K213351ds Head 32ch 3.0TMOS2021-10-29
3063121838562273K212864dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5TMOS2021-12-01
3063121688839533K212704Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound SystemIYN2021-09-24
558651830706808K211816Brightway Brand, Nitrile Examination Gloves, Powder Free (Blue) Tested for Use with Chemotherapy Drugs and Fentanyl CitrateLZA2022-11-02
3063121969078124K203087CombiDiagnost R90JAA2020-12-03
3063121611198509K202564DigitalDiagnost C90MQB2020-09-30
3063121107210882K202216EPIQ Series Diagnostic Ultrasound SystemsIYN2020-09-02
3063121196917812K201053PercuNav Image Fusion and Interventional NavigationJAK2020-05-14
3063121243798821K201012EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound SystemIYN2020-05-01
3063121057865904K200304EPIQ Diagnostic Ultrasound SystemIYN2020-03-06
3063121881972235K193438DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium)HBL2020-06-02
3063121455586984K192226Lumify Diagnostic Ultrasound SystemIYN2019-09-06
3063121081069158K191813MobileDiagnost wDR 2.2IZL2019-08-02
2251171915209008K191443MSDI Dental Implants SystemDZE2020-06-26
3063121184371003K190461Achieva 1.5T, 3.0T and Intera 1.5T MR SystemsLNH2019-06-04
3063121565559224K183063Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR SystemsLNH2019-02-14
3063121179389590K182857EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound SystemIYN2018-11-09
3063121738564168K182529
2226681790882908K182143ALFA GATE Dental Implants SystemDZE2019-10-03
3063121609003109K181485EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound SystemIYN2018-07-27
3063121055012894K181166Trilogy EvoCBK2019-07-18
2209371829188143K173943Dental High-speed Handpiece and AccessoriesEFB2018-07-24
3063121171847777K173433ProxiDiagnost N90OWB2018-02-05
3063121336953846K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound SystemIYN2017-10-04
3063121224314874K172056InnoSight Diagnostic Ultrasound SystemIYO2017-12-13
2370781145292030K170787Powered Wheelchair DYW30A(D09)ITI2017-08-09
558651875998745K170686Nitrile Examination Gloves, Powder Free [Purple] Tested for Use with Chemotherapy DrugsLZA2017-07-14
707101274097865K170663Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable ManometerBTM2018-05-11
3063121749159569K170086Pinnacle Radiation Therapy Planning SystemMUJ2017-02-09
3063121059791294K163661P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex CoilMOS2018-03-21
558651295985325K163267NITRILE EXAMINATION GLOVELZA2017-03-24
3063121881137052K163210Philips CombiDiagnost R90JAA2017-01-31
3063121773746871K163120EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50 Diagnostic Ultrasound System; Affiniti 70 Diagnostic Ultrasound SystemIYN2017-01-10
3063121327644084K163116Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3LNH2017-01-06
2061251571347246K162870CIMLRE F1 and CIMILRE S3HGX2017-03-07
3063121428285861K162863dS Small Extremity 16CH 1.5T CoilMOS2016-11-07
3063121286013744K162549Lumify Ultrasound SystemIYN2016-10-03
3063121609994550K162329CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound SystemIYN2016-09-14
558651318677358K162294BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGSLZA2017-04-21
558651556184163K162186BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIMLZC2017-03-31
3063121516084244K162177dS FootAnkle I6CH 1.5T CoilMOS2016-09-14
558651470773085K162146Brightway Brand Nitrile Examination Gloves, Powder Free (Lavender)LZA2017-01-05
3063121811433801K1620011.5T and 3.0T 16 CH GE Shoulder CoilsMOS2016-08-31
558651990254483K161215Brightway Brand Nitrile Examination Gloves, Powder Free, [Sterling/Grey] Tested For Use With Chemotherapy DrugsLZA2016-12-21
3063121734630804K160807EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound SystemIYN2016-04-06
3063121548759238K153480ClearVue850 Diagnostic Ultrasound SystemIYN2015-12-16
3063121526899686K152899Philips Lumify Diagnostic Ultrasound SystemIYN2015-10-30
707102021628964K152521Seal Rite Non-Rebreathing ValveCBP2016-06-03
3063121675696803K152330Expression MR400 MRI Patient Monitoring SystemMWI2015-12-23
3063121490275743K151904SyncVision SystemOWB2015-07-31
3063121862634147K151681IntelliVue Patient MonitorDSI2015-07-17
3063121194455784K150310IntelliVue Patient MonitorDSI2015-05-13
3063121831483539K141736PHILIPS PROGRADE; PHILIPS ELEVA WORKSPOT FOR DIGITAL DIAGNOSTMQB2014-07-25
3063121103342315K141381DURADIAGNOSTKPR2014-06-12
3063121492506195K141369VISIQ DIAGNOSTIC ULTRA SOUND SYSTEMIYN2014-07-02
3063121514399236K140535PHILIPS AVALON FETAL / MATERNAL MONITORS FM20, FM30, FM40 AND FM50HGM2014-11-25
707101152086804K140228DISPOSABLE TRACHEAL TUBEBTR2014-12-18
3063121423899749K133961SURESIGNS VS3, SURESIGNS VS4DSJ2014-06-26
3063121575388847K132304EPIQ DIAGNOSTIC ULTRASOUND SYSTEMIYN2013-08-21
475051962795979K131654STARCHMARK BREAST TISSUE MARKER; STARCHMARK ULTRACOR BREAST TISSUE MARKERNEU2013-06-27
3063121688678151K131382EXPRESSION MR200 MRI PATIENT MONITORING SYSTEM, EXPRESSION IP5 INFORMATION PORTALMWI2013-07-15
3063121188870238K130684PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATORMKJ2013-10-18

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MOS522021-12-23
LZA302022-11-02
IYN282021-09-24
LYY202006-04-10
LNH132019-06-04
MKJ92013-10-18
MHX92012-08-29
KGO81999-07-26
LLZ62012-02-16
MWI52015-12-23
KNW52001-03-22
DZE42020-06-26
OWB42018-02-05
IYO42017-12-13
HGM42014-11-25
FLL42004-09-13
BTM32018-05-11
BTR32014-12-18
HPZ32013-01-31
CCK32006-02-03
HGX22022-12-23
JAA22020-12-03
MQB22020-09-30
IZL22019-08-02
LZC22017-03-31
CBP22016-06-03
DSI22015-07-17
NEU22013-06-27
CAF22009-11-10
ITX22009-07-17
IZW22009-07-14
HBL12020-06-02
JAK12020-05-14
CBK12019-07-18
EFB12018-07-24
ITI12017-08-09
MUJ12017-02-09
DSJ12014-06-26
KPR12014-06-12
LKD12011-09-30