Dave

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96153353002806858Dave Heiselt1N2026-01-012140 E Southlake Blvd Ste L703 Southlake TX US 76092
96160863006076154Dave Hunter1N2026-01-015919 Sea Otter Place Suite 200 Carlsbad CA US 92010
96161993003768492Dave Kim1N2026-01-017505 Fannin St Ste 610 Houston TX US 77054
97106133000199218Dave Kim1N2026-01-017505 Fannin St Ste 610 Houston TX US 77054
30041160083004116008Dave Kim1N2026-01-017505 Fannin St Ste 610 Houston TX US 77054
30047063133004706313Dave Kim1N2026-01-017505 Fannin St Ste 610 Houston TX US 77054
30050829463005082946Dave Kim1N2026-01-017505 Fannin St Ste 610 Houston TX US 77054
30075025413007502541Dave Hunter1N2026-01-015919 Sea Otter Place Suite 200 Carlsbad CA US 92010
30082614133008261413Dave Hunter1N2026-01-015919 Sea Otter Place Suite 200 Carlsbad CA US 92010
30094237533009423753Dave Loftus1N2026-01-01240 thelma ave Merrick NY US 11566
30100679933010067993Dave Hunter1N2026-01-015919 Sea Otter Place Suite 200 Carlsbad CA US 92010
30103764463010376446Dave DeCaprio1N2026-01-011100 Military Road Kenmore NY US 14217
30111200893011120089Dave Hunter1N2026-01-015919 Sea Otter Place Suite 200 Carlsbad CA US 92010
30118918013011891801Dave Kim1N2026-01-017505 Fannin St Ste 610 Houston TX US 77054
30129365133012936513Dave Kim1N2026-01-017505 Fannin St Ste 610 Houston TX US 77054
30135990333013599033Dave Kim1N2026-01-017505 Fannin St Ste 610 Houston TX US 77054
30150962183015096218Dave Jones1N2026-01-011513 Welch St Fort Collins CO US 80524
30153511833015351183Dave Kim1N2026-01-017505 Fannin St Ste 610 Houston TX US 77054
30155373093015537309Dave Kim1N2026-01-017505 Fannin St. Suite 610 Houston TX US 77054
30170048603017004860Dave Kim1N2026-01-017505 Fannin St Ste 610 Houston TX US 77054
30212307773021230777Dave Kim1N2026-01-017505 Fannin St Ste 610 Houston TX US 77054
30233464393023346439Dave Kim1N2026-01-017505 Fannin St Ste 610 Houston TX US 77054
30248217003024821700Dave Kim1N2026-01-017505 Fannin St Ste 610 Houston TX US 77054
30299155313029915531Dave Kim1N2026-01-017505 Fannin St Ste 610 Houston TX US 77054
30300897873030089787Dave Kim1N2026-01-017505 Fannin St Ste 610 Houston TX US 77054

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
156141657358823K992454VENAFLOW SYSTEM, MODEL 30AJOW2000-01-13
156141810674408K982828FORTE, MODELS CPS 400 STIM, CPS 200 STIMIPF1998-11-06
156141120461298K973024INTELECT LEGEND ULTRASOUNDIMI1997-11-10
156141617137642K970426VALUETRODEGXY1997-05-09
156141501440770K964238AIRCAST VENA FLOW STERILE DISPOSABLE CUFFSJOW1997-09-08
156141804617560K96377324457-010 SECURE ALL PELVIC HOLDER/24458-010 SECURE ALL BODY BELTFMQ1996-11-21
156141193182373K963564PERSONAL LIMB HOLDER (24444-200,300,24444-KIT)FMQ1996-11-22
156141900396350K963563ULTRACARE VEST STYLE BODY HOLDER WITH SAFETY SLEEVES, SMALL(24454-010,020,030,040,015,025,035,045,115,125,135,145)FMQ1996-11-21
156141895747133K963561ULTRA CARE VEST STYLE BODY HOLDER, SMALL (24455-010,020,030,040,24456-010,020,030,040)FMQ1996-11-21
156141655492109K963559WRPAROUND LIMB HOLDER (24446,24446-350,24447-010,24449-010)FMQ1996-11-22
156141795101761K963557SYSTEM 2 ZIPPERED BODY HOLDER, SMALL/MEDIUM 24453-010,24453-020,24453-030FMQ1996-11-21
156141805991656K963556SECURE-ALL 1-PIECE BODY HOLDER, SMALL/MEDIUM (24451-010,020,24452-010,020,030)FMQ1996-11-21
156141370368452K96355424448-010 SECURE-ALL FINGER CONTROL MITTFMQ1996-11-21
156141218296318K963552QUICK RELEASE LIMB HOLDER (24442,24442-050,24442-350)FMQ1996-11-22
156141471288124K963492PROTECTIVE RESTRAINTFMQ1996-11-12
156141421314926K963490PROTECTIVE RESTRAINT - BELTSFMQ1996-11-12
156141053358755K963489WHEEL CHAIR ACCESSORYFMQ1996-11-12
156141623329477K963169RAPID-AID THERAPEUTIC/SCANNING ULTRASOUND GELITX1996-11-12
156141448688398K946298BIOSTIM-HVIPF1995-05-11
156141171402349K932900AIRCAST VENAFLOW SYSTEMJOW1993-10-25
156141537688399K925643RX FIT MEDICAL STOCKINGSDWL1993-12-06
156141408260179K921608PRESSSION, SEQUENTIALJOW1992-12-30
156141571303048K915333ELECTRODE USING PROMEON RG-60 SERIES GELGXY1992-01-14
156141117597300K902195TBD TENS REUSABLE ELECTRODEGXY1990-06-08
156141366113545K896817MODEL T11 FLUIDOTHERAPY UNITLSB1991-01-18
156141905664034K874469TRANSCUTANEOUS ELECTRIC NERVE STIMULATION (TENS)GXY1988-01-28
156141859902315K873368TECNOL COMPRESSION KNEE DRESSINGLLK1987-12-11
156141176354329K871802
156141736041381K852267ELECTRICAL NERVE STIMULATION(TENS) ELECTRODESGXY1985-06-18
156141651534213K801272TECNOL QUICK RELEASE LIMB HOLDERFMQ1980-06-17
156141904152536K790699TECNOL BODY HOLDERFMQ1979-06-01
3005801602890858K260320Lunit INSIGHT MMG (v1.1.10)QDQ2026-04-23
231921527005876K260093Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)OAS2026-03-31
3005801857522430K253796Lunit INSIGHT DBT (V1.2)QDQ2026-03-26
2937121308617180K253348TargetCool-eGEH2025-10-15
2937121049352269K253114TargetCoolâ„¢ (RM-DT02W)GEH2025-10-16
3074191763227380K250518SMART M-CELL Bone Marrow Concentration SystemQBV2026-04-02
3074192024633818K250516SMART M-CELL PRP Concentration SystemQBV2026-04-02
231921201250316K243088Green X 12 SE (PHT-40CHS)OAS2025-02-21
231921256187677K243081Green X 21 (PHT-90CHO)OAS2025-02-14
3005801005884959K242652Lunit INSIGHT DBT v1.1QDQ2024-10-04
3104842027679193K242583AT-Patch (ATP-C130/ATP-C70)DSH2025-05-02
231921091982506K240040VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan)MUH2024-10-25
3234321098103581K233200XPLUS 35 Series (XPLUS 35, XPLUS 35FD)OWB2023-11-16
187421389506054K232143Applanation Tonometer HT-5000HKY2023-10-23
231921452917792K231796Grreen X 12 (Model: PHT-75CHS)OAS2023-07-19
3005801011360573K231470Lunit INSIGHT DBTQDQ2023-11-06
788441945692998K231437LF900IRP2023-07-19
3234321877370948K230800XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F PF50KPR2023-11-02
231921106382442K223058EzRay Air 2 Wall (Model: VEX-S350W)EHD2022-10-26
2982362041721642K222738Point implant systemDZE2023-04-13
2860891542827144K221144PEDRA-1417MC, PEDRA-1417MG, PEDRA-1417FC, PEDRA-1417FGMQB2022-05-13
201041016524348K213749G7, Dental Operative Unit and AccessoriesEIA2023-04-03
2860891313660745K213520AXIR-CXLLZ2022-08-19
2313172068452660K213405MINE ALNU (Model: Mine 2.1)IZL2022-07-10
3005801089538935K211733Lunit INSIGHT CXR TriageQFM2021-11-10
3005801563445143K211678Lunit INSIGHT MMGQDQ2021-11-17
231921077659445K210329Green X 18(Model : PHT-75CHS)OAS2021-02-18
231921889480654K203797vatech A9 (Model : PHT-30CSS)OAS2021-01-25
231921296699662K203667EzRay M (Model: VMX-P300)IZL2021-02-02
788441056911615K203498LX9maxIRP2021-07-02
788441395041721K203417DVT-4000SJOW2021-03-28
788441270837412K203353DVT-PROJOW2021-04-22
788441158324056K203016DVT-2600JOW2020-12-05
1743281755391851K202588BNA PlatformOLU2020-12-07
788441606784836K202395SP-1000, SP-2000IRP2021-09-01
187421453643822K202097Fundus CameraHKI2021-02-02
156141938481998K201653Compex Sport Elite 3.0NGX2020-11-27
231922029950562K201627Dental Computed Tomography X-Ray System, Green XOAS2020-10-27
2373461260954182K200787BSD3543WMQB2020-04-23
156141828950974K200561StimPlus Patch, StimPlus Patch, StimPlus PatchNUH2020-07-01
231921466716974K200182EzRay Air Portable (Model: VEX-P300)EHD2020-02-11
187421647793343K191615Huvitz Imaging SystemNFJ2019-07-18
2860891763196869K180989PEDRA-17F Digital Flat Panel X-ray DetectorMQB2018-06-13
156141700205497K180865ZMI Self-Adhesive ElectrodesGXY2018-06-28
1774101700205497K180865ZMI Self-Adhesive ElectrodesGXY2018-06-28
2313171040042320K180671MINEEHD2019-06-05
2263111206186413K171890BEXCORE Breast Biopsy System, Biopsy NeedleKNW2018-08-20
2373461927337273K171485BSD4343R Digital Flat Panel X-ray DetectorMQB2017-06-21
3459021172537972K170918Compex Sport EliteNGX2017-06-20
231921613373641K170731System, X-Ray, Extra oral Source, Digital, PaX-i Plus, PaX-i InsightMUH2017-04-04
231921169025243K170066Green16/Green18 (Model: PHT-65LHS)OAS2017-06-16
231921608534409K163705EzRay Air WEHD2017-01-24
3234321569042729K163140SPINEL 12HD Interventional Fluoroscopic Mobile X-ray SystemOWB2017-05-26
231921100911131K162660Green Smart (Model: PHT-35LHS)OAS2016-10-20
2373461075686045K162487BSD3543 Digital Flat Panel X-ray DetectorMQB2016-10-14
187421257307628K161829Huvitz Imaging SystemNFJ2017-04-06
231922035168929K161063EzRay Air (Model VEX-P300)EHD2016-09-01
231921352291723K160882PaX-i3D Green Premium (Model: PCT-90LH)OAS2016-10-28
2373461686616581K160204BSD4343 Digital Flat Panel X-ray DetectorMQB2016-06-09
156141636960237K160138Adhesive ElectrodesGXY2016-08-11
3234321512656362K160065GEMSS Medical System Surgical Mobile Fluoroscopic X-ray SystemOXO2016-05-20
156141046004032K153520Electronic Pulse StimulatorNUH2016-05-05
1774101984630277K153224VitalStim(R) Plus Electrotherapy SystemIPF2016-02-17
231921588628530K152106Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D SmartOAS2015-10-23
201041852824546K151996TAURUS C1EIA2016-01-22
788442039145781K150980Venous Assist SystemJOW2016-05-12
788441520823890K150033Air Compressible Limb Therapy SystemIRP2015-04-20
156141184987830K141260ELECTRONIC PULSE STIMULATORNUH2014-09-17
3234321411820069K133695TITAN 11KPR2014-08-07
3234321326529569K132289GEMSS MEDICAL SYSTEMS SURGICAL MOBILE FLUOROSCOPIC X-RAY SYSTEMJAA2014-06-16
156141142053437K132284VECTRA NEO CLINICAL THERAPY SYSTEMIPF2014-04-10
156141413408604K130987VALUTRODE NEUROSTIMLATION ELECTRODESGXY2013-07-17
231921352767633K130585PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM, PAX-I DIGITAL EXTRAORAL SOURCE X-RAY SYSTEMMUH2013-07-15
231921856233891K130432PHT-6500, PHT-60CFOOAS2013-05-31
156141946103572K124016EMPI PHOENIXIPF2013-05-06
231921426285147K123493VEX-S 100W INTRAORAL X-RAY SYSTEMEHD2012-12-13
231921206905817K122606PHT-6500; PHT-60CFO; PAX-I3DOAS2012-11-20

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OAS192026-03-31
FMQ141996-11-22
JOW132021-04-22
MUH92024-10-25
EHD92022-10-26
GXY92018-06-28
IPF92016-02-17
IRP72023-07-19
MQB62022-05-13
QDQ52026-04-23
NGX42020-11-27
IMG42004-04-12
EIA32023-04-03
NUH32020-07-01
QBV22026-04-02
GEH22025-10-16
OWB22023-11-16
KPR22023-11-02
IZL22022-07-10
OLU22020-12-07
NFJ22019-07-18
HJO22009-12-03
ITH22006-02-24
IMI22003-12-03
LSB22001-07-06
DSH12025-05-02
QZQ12024-09-30
HKY12023-10-23
DZE12023-04-13
LLZ12022-08-19
QFM12021-11-10
HKI12021-02-02
KNW12018-08-20
OXO12016-05-20
JAA12014-06-16
IMJ12009-03-18
GZJ12007-11-27
LIH12007-06-29
DRL12007-01-25
ILY12004-09-08