FDA.reportPublic FDA data

Jerry Doane

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30077403943007740394Jerry Doane1N2027-01-0115815 SW 11th Court Rd Ocala FL US 34473
80221663002513507Jerry Doane1N2026-01-0115815 SW 11th Court Rd Ocala FL US 34473
80437851000153953Jerry Doane1N2026-01-0115815 SW 11th Court Rd 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
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
30171404153017140415Jerry Doane1N2026-01-0115815 Sw 11th Court Rd Ocala FL US 34473
30172104883017210488Jerry 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
2759441111826917P110010PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEMNIQ2011-11-22
444881719762218K992019LAGLOVE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)KGO1999-08-05
444881517447517K992018LAGLOVE POWDERED LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (150 MICROGRAMS OR LESS)KGO1999-07-30
444881310161928K991950LAGLOVE BRAND NITRILE SURGICAL GLOVE-STERILE (POWDER-FREE)KGO1999-08-12
444881903549952K991949LAGLOVE BRAND NITRILE SURGICAL GLOVE-STERILE (POWDERED)KGO1999-08-12
444881864099105K991749LAGLOVE BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDER FREE CONTAINING 50 MLGM OR LESS OF WATER EXTRACTABLE PROTEIN PELYY1999-06-23
444881804011872K991748LAGLOVE BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDERED CONTAINING 150 MLGM OR LESSOF WATER EXTRACTABLE PROTEIN PER GLYY1999-06-23
3063121747113581K991671HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEMIYO1999-06-18
3063121561087045K991366DAUM MRI/CONVENTIONAL BIOPSY KITKNW1999-06-25
444881481948479K990883LAGLOVE BRAND BLUE COLOLRED NITRILE EXAMINATION GLOVE (POWDERED)LZA1999-08-10
444881767345952K990882LAGLOVE BRAND COLORED NITRILE EXAMINATION GLOVES (POWDER FREE)LZA1999-05-21
444881993997469K990420LAGLOVE BRAND NITRILE EXAMINATION GLOVE (POWDER FREE)LZA1999-03-29
444881665958632K990415LAGLOVE BRAND NITRILE EXAMINATION GLOVES (LIGHTLY POWDERED)LZA1999-03-29
3063121186320847K990339SONOS 5500 IMAGING SYSTEM M2424A VERSION B.OIYN1999-02-18
444882027575463K990285LAGLOVE BRAND LATEX EXAMINATION GLOVES (LOW PROTEIN)LYY1999-02-18
444881030691062K990270LAGLOVE BRAND LATEX EXAMINATION GLOVE (POWDER FREE)LYY1999-02-18
444881721290805K990268LAGLOVE BRAND POLYMER COATED LATEX EXAMINATION GLOVE (POWDER FREE)LYY1999-02-24
3063121946999755K983069PHILIPS DUO DIAGNOSTOWB1998-11-02
3063121890299756K981737K-DEFIB/PACE ADULT ELECTRODE MODEL NUMBER KDP-60MKJ1998-12-09
3063121136631940K981320DAUM BONE BIOPSY SETKNW1998-06-29
2759441472438755K980155ENDOBUTTON CONTINUOUS LOOPGAT1998-04-01
3063121004695923K974576DAUM BIOPSYGUNKNW1998-03-06
2759441746607762K972326PEBA ANCHOR/SUTURE COMBINATIONMBI1998-02-06
2759441539884711K971320CRE BALLOON DILATATION CATHETERKNQ1997-10-09
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
2759441853068309K951589MANUAL SURGICAL INSRUMENTGEI1995-05-03
3063121243538262K942481FUJI ULTIMA EC-MA CASSETTEIXA1994-07-29
2759441621087133K935426PREPERITONEAL DISTENTION BALLOON SYSTEMGCJ1994-01-26
2759441035969146K934738AUTOSUTURE ENDOSCOPIC SUTURING DEVICEOCW1994-03-16
2759441811343577K934426NERVE INTEGRITY MONITOR-2 (NIM-2 XL)ETN1994-05-13
3063121678469666K934396QUADRATURE LOWER EXTREMITY COILLNH1993-11-24
2759441209412169K934370BIP BIOPSY NEEDLE MODIFICATIONFCG1994-03-07
3063122039844030K925910HEWLETT-PACKARD MODEL M1018A TCPO2/TOPCO2 MODULEKLK1993-07-29
2759441683266447K925640XOMED-TREACE EMG ENDOTRACHEAL TUBEENETN1993-08-17
2759441082935804K924011ORIGIN BLUNT TIP SURGICAL TROCARGCJ1993-07-09
2759441373673662K922123AUTO SUTURE DISPOSABLE ENDOSCOPIC SPECIMEN POUCHGCI1993-02-01
2759441903057104K920068AUTO SUTURE ENDOSCOPIC MINI-RETRACTORGCJ1992-09-17
2226681924676972K915375ODONTIT OSSEOINTEGRATED IMPLANTS SYSTEMDZE1992-06-03
2759441016606398K913762MONOSCOPY(TM) BRAND, ENDOBAGGCJ1991-10-28
707102057213493K913749EDENTRACE AIRFLOW 3171/SLEEP LAB AIRFLOW 3170BZQ1992-07-02
444881134247192K912988LATEX EXAMINATION GLOVESLYY1991-08-02
2759441362564251K904578MODIFICATION AUTO SUTURE(R) ENDOSCOPIC CLAMPGET1990-10-30
2759441697302779K903205AUTO SUTURE(R) ENDOSCOPIC CLAMPHDA1990-10-11
101021907043435K900927CODERE-DURETTE ORBITAL FLOOR IMPLANTHQX1990-05-15
2759441412031594K900486APPOSE UNITY STERILE DISPOSABLE SKIN STAPLERGDT1990-04-20
2759441737588729K890941MODIFIED SUTURE DISP. ENDOSCOPIC SURGICAL CLIP APPGDO1989-04-07
3063121783277382K883793DISPOSABLE TEMPERATURE PROBES (SEVERAL MODELS)FLL1988-11-21
2759442032010248K864102LIGACLIP 20/20* MULTIPLE CLIP APPLIERFZP1986-11-05
2759441834518437K863330DISPOSABLE PNEUMOPERITONEUM NEEDLEFHO1986-10-02
3063121405412926K851895POLYGEL ULTRASOUND GELIYO1985-09-27
2759441116489405K833417ENDOSCOPIC RETROGRADEODD1983-11-28
2759441519497465K822572POLYHESIVE PATIENT RETURN ELECTRODEGEI1982-09-21
2061251954292363K260643Cimilre Dual MaxHGX2026-08-21
2759441378306840K252612INDIGO® Aspiration System – Lightning Flash Aspiration Tubing; INDIGO® Aspiration System – Lightning Bolt Aspiration TubingQEW2025-10-16
2759441682458346K251627BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (white); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid blue)MBI2025-06-25
2759441516591418K250066Resolution Clip (M00522600); Resolution Clip (M00522601); Resolution Clip (M00522602); Resolution Clip (M00522610); Resolution Clip (M00522611); Resolution Clip (M00522612)PKL2025-02-06
2759441459941189K243315ProGrip™ Self-Gripping Polypropylene MeshFTL2025-01-17
2759441493304713K232373Progrip™ Self-Gripping Polypropylene MeshFTL2024-01-18
2759441474183940K230320NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal TubeETN2023-10-26
2759441310535345K223488ClosureFast™ Endovenous Radiofrequency Ablation CatheterGEI2023-03-23
2759441989736394K223218Parietene Macroporous MeshFTL2022-12-02
2759441670782026K222971ULTRABUTTON QUAD Adjustable Fixation Device; ULTRABUTTON BB Adjustable Fixation Device; ULTRABUTTON TIB SMALL Adjustable Fixation Device; ULTRABUTTON TIB MEDIUM Adjustable Fixation Device; ULTRABUTTON TIB LARGE Adjustable Fixation DeviceMBI2023-02-17
2759441898171662K221919DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing setsHRX2023-03-09
2061251466080587K221708CIMILRE Free-T2 PlusHGX2022-12-23
2759441126453281K221515StoneSmart Connect Console, LithoVue Elite Single Use Digital Flexible Ureteroscope Standard w/Pressure Monitoring, LithoVue Elite Single Use Digital Flexible Ureteroscope Reverse w/Pressure MonitoringFGB2023-02-02
2759441142399774K221013GIA Auto Suture Stapler with DST Series TechnologyGDW2022-05-05
2759441544403540K221003Autosuture EEA Stapler / circular stapler with DST Series Technology / EEA Autosuture Circular Stapler with DST Series Technology / DST Series EEA Stapler / DST EEAGDW2022-09-30
2759441368101806K220586Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D 3D Anatomical Mesh, Versatex Monofilament MeshFTL2022-06-22
2759441493969054K213818VersaOne Optical Trocar with Fixation Balloon Cannula, VersaOne Universal Fixation Balloon CannulaGCJ2022-06-27
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
2759441158905689K213246NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm LongETN2022-03-21
3063121838562273K212864dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5TMOS2021-12-01
2759441564324439K212724BD Vacutainer UltraTouch Push Button Blood Collection SetJKA2022-02-04
3063121688839533K212704Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound SystemIYN2021-09-24
2759441332473703K210423Werewolf+ Coblation System, Werewolf+ Controller, Werewolf Fastseal 6.0 Hemostasis WandGEI2021-06-24
2759441165249075K210114Rebar Micro CatheterKRA2021-02-16
2759441487937971K210083Indigo System Aspiration Catheter 7, Indigo Aspiration System Separator 7, Lightning 7QEW2021-02-09
2759441539634830K203393FAST-FIX FLEXGAT2021-02-01
3063121969078124K203087CombiDiagnost R90JAA2020-12-03
2759441026015977K202917LigaSure Exact Dissector, Nano-coatedGEI2021-03-23
3063121611198509K202564DigitalDiagnost C90MQB2020-09-30
2759441450761038K202522Synchro SELECT GuidewireMOF2020-09-25
2759441870447276K202318Marathon Flow Directed Micro CatheterKRA2020-09-14
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
2759441257769968K2008183DMax MID Anatomical MeshFTL2020-07-17
3063121057865904K200304EPIQ Diagnostic Ultrasound SystemIYN2020-03-06
2759441278865880K193579PlasmaBlade X 3.0S LIGHTGEI2020-03-24
3063121881972235K193438DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium)HBL2020-06-02
2759441959890330K193131BD Quincke Spinal NRFit Needle, BD Whitacre Spinal NRFit Needle, BD Spinal Introducer NRFit NeedleBSP2020-09-29
2759441894913001K192443Dextile Anatomical MeshFTL2019-12-06
3063121455586984K192226Lumify Diagnostic Ultrasound SystemIYN2019-09-06
3063121081069158K191813MobileDiagnost wDR 2.2IZL2019-08-02
2251171915209008K191443MSDI Dental Implants SystemDZE2020-06-26
2759441564254715K190843Synchro2 Support GuidewireMOF2019-05-01
3063121184371003K190461Achieva 1.5T, 3.0T and Intera 1.5T MR SystemsLNH2019-06-04
2759441544019166K183470Precision Ideal Eyes ArthroscopesHRX2019-01-07
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
3063121738564168K182529Xperius Ultrasound SystemIYN2018-10-23
2226681790882908K182143ALFA GATE Dental Implants SystemDZE2019-10-03
2759441271654386K181730BD Vacutainer Eclipse UltraFill Blood Collection NeedleFMI2019-03-01
3063121609003109K181485EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound SystemIYN2018-07-27
2759441018791952K181257PlasmaBlade X 3.0S, PlasmaBlade X 4.0GEI2018-08-02
3063121055012894K181166Trilogy EvoCBK2019-07-18
2759441507952254K180499Reprocessed LigaSure Maryland Jaw Sealer/DividerNUJ2018-04-23
2209371829188143K173943Dental High-speed Handpiece and AccessoriesEFB2018-07-24
2759441798093650K173796Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh), Parietex Composite Mesh (PCO and PCO-OS references), Parietex Optimized Composite Mesh (PCO-X, PCO-FX and PCO-OSX references)FTL2018-03-09
2759441018997943K173741Reprocessed ArthoCare Ablation WandNUJ2018-03-05
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

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MOS522021-12-23
IYN292021-09-24
GEI182023-03-23
FTL162025-01-17
LNH132019-06-04
GCJ122022-06-27
LZA102010-06-18
GDW92022-09-30
MKJ92013-10-18
MHX92012-08-29
LYY82010-06-08
MBI72025-06-25
KNW72017-09-14
FZP62015-09-14
LLZ62012-02-16
ETN52023-10-26
MWI52015-12-23
GAT42021-02-01
DZE42020-06-26
OWB42018-02-05
IYO42017-12-13
JOH42015-07-14
HGM42014-11-25
FLL42004-09-13
KGO41999-08-12
HGX32026-08-21
JKA32022-02-04
KRA32021-02-16
BTM32018-05-11
NUJ32018-04-23
HAW32015-03-25
BTR32014-12-18
HPZ32013-01-31
LNS32012-03-01
CCK32006-02-03
QEW22025-10-16
HRX22023-03-09
JAA22020-12-03
MQB22020-09-30
MOF22020-09-25