FDA.reportPublic FDA data

BIOTRONIX HEALTHCARE INDUSTRIES INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30101311373010131137BIOTRONIX HEALTHCARE INDUSTRIES INC.1Y2026-01-014700 Millenia Blvd Ste 500 Orlando FL US 32839

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1546831424219406K993118BIOTEQUE A.V. FISTULA NEEDLE SETFIE1999-12-17
1546831507583818K223323Blood Collection Needle (with/without Needle Holder)JKA2023-03-24
1546831321395069K222141Safety Blood Collection Needle (Without Needle Holder)JKA2022-10-21
1546831710232589K222124Sterile Hypodermic Syringe with/without Needle, Hypodermic NeedleFMI2022-11-04
1546831546010858K221521Disposable Safety LancetFMK2022-10-28
1546831120345318K214075Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection / Infusion Set (with/without needle holder)FMI2022-04-12
1546831868062168K211555Hypodermic Safety Needle; Hypodermic Safety Needle with SyringeMEG2021-10-18
1546832031020193K210745Heel Incision Safety LancetFMK2021-08-26
1546831385219970K202698Prefilled SyringeEZL2020-12-15
1546831783995716K200027Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without Holder, Luer Access Device-holder with Preattached Multiple Sample AdapterJKA2020-09-09
1546831308500524K192230MF SAFECATHFOZ2020-04-23
1546831705465149K190183Hypodermic Safety Needle, Hypodermic Safety Needle with SyringeMEG2019-10-04
1546831208024196K181276CONOD Enteral Feeding SetsPIF2018-07-12
1546832010917268K173847Disposable Ultra Reinforced Surgical GownFYA2019-01-16
1546831692396113K172763Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with Holder, Safety Blood Collecting Needle with Holder, Blood Collecting Set, Safety Blood Collecting Set, Blood Collecting Set with Holder, Safety Blood Collecting Set with HolderJKA2018-06-04
1546831156928378K162188Enteral Syringe with ENFit Connector (10 ml to 60 ml), Enteral Syringe with ENFit Low Dose Tip (1 ml to 5 ml)PNR2016-09-22
1546831435944067K153496Disposable Surgical Face MaskFXX2016-06-15
1546831023009379K151991
1546831232328157K142797I.V. CatheterFOZ2015-06-18
1546831144679180K140356SUMMED HIGH PRESSURE LINEDQO2015-03-20
1546831867776363K140237DISPOSABLE NEBULIZER SETCAF2015-01-08
1546832026997030K133795SUMMED INFLATION DEVICE KITMAV2014-12-12
1546831999871467K133343WONDFO RAPID STREP A TESTGTY2014-01-31
1546831788933873K133058INSULIN PEN NEEDLEFMI2014-02-25
1546831075731459K132709VR MEDICAL HEAT AND MOISTURE EXCHANGER AND FILTERCAH2014-07-30
1546831332878458K131754WONDFO COCAINE URINE TEST (COC 100), WONDFO CANNABINOIDS URINE TEST (THC 40)DIO2013-07-31
1546831415636358K131511DISPOSABLE CIRCULAR STAPLER, DISPOSABLE CURVED CUTTER STAPLER, DISPOSABLE LINEAR STAPLERS AND RELOADS, DISPOSABLE HEMORRGDW2013-07-05
1546831860856177K130737SYNTHETIC ABSORBABLE SUTUREGAM2014-01-14
1546831836863314K130735SYNTHETIC ABSORBABLE SUTUREGAM2014-01-14
1546831869697198K130273PANPAC VAGINAL DILATORSHDX2013-08-08
1546831481277705K130087PANPAC WORD/BARTHOLIN CATHETERKNA2014-01-10
1546831179851529K123475SHOOCIN INTRODUCER KITDYB2014-02-03
1546831443827946K123473HOPER PTCA BALLOON CATHETERLOX2013-08-13
1546831419404098K123030COMPRESSOR NEBULIZER MODEL MCN-S600XXCAF2013-12-19
1546831754282578K121474DISPOSABLE LINEAR STAPLER, DISPOSABLE LINEAR CUTTERGDW2012-07-16
1546831477699587K120475ANESTHESIA CONDUCTION NEEDLESBSP2012-12-21
1546831689451744K120119SUNMED GUIDE WIREDQX2012-05-11
1546831183132224K112204
1546831539093019K112057KDL SYRINGES AND NEEDLEFMF2011-12-14
1546831271522406K111837RADIAL ARTERY COMPRESSION TOURNIQUETDXC2011-09-27
1546831473502596K111559SURGICAL MASKSFXX2011-09-16
1546831164349444K110853VR MEDICAL ENTERAL ORAL SYRINGEFPD2011-05-13
1546831508611908K110421DISPOSABLE INSULIN SYRINGEFMF2011-04-26
1546831712040921K110269WELL LEAD ENDOTRACHEAL TUBE WITH EVACUATION LUMEN-ORALBTR2011-08-26
1546831583438641K110182CANNABINOIDS URINE TESTLDJ2011-05-20
1546832022199172K102898BELLOTA SONOHYSTEROGRAPHY CATHETER WITH CERVICAL CONE, BELLOTA SONOHYSTEROGRAPHY CATHETER WITHOUT CERVICAL CONELKF2011-12-15
1546831851985413K102833DISPOSABLE HEMODIALYSIS ACCESS CATHETER SETSMPB2011-11-18
1546832005629314K102372OBS DISPOSABLE ELECTROSURGICAL PADS, MONOPOLAR, BIOPOLAR, MODELS GBS-DM, GBS-DBGEI2010-11-03
1546831028118991K102316GLUCOSE SHEPHERD BLOOD GLUCOSE MONITORING SYSTEMCGA2011-10-07
1546831765517944K101136FISIO CHAMBER SPACENVP2011-01-28
1546831288749777K100723DISPOSABLE CIRCULAR STAPLER, DISPOSABLE CIRCULAR STAPLER MODEL KYGW-25.5, KYGW-28.5GDW2010-04-30
1546831840105434K093910IMPROVACUTER GEL & CLOT ACTIVATOR TUBEJKA2010-07-12
1546831135152512K092984PANPAC UTERINE INECTOR, MODEL UI-4.0, UI-2.0LKF2010-04-07
1546831005158084K092983PANPAC HSG CATHETER SETLKF2010-06-07
1546831575959213K092982THE PANPAC SUCTION CURETTEHHK2010-07-26
1546831034958984K092981PANPAC VAGINAL PESSARYHHW2010-07-22
1546831787975014K092980PANPAC UTERINE MANIPULATOR INJECTOR, MODEL UMI 4.5LKF2010-03-11
1546831852657256K092886WELL LEAD ENDOBRONCHIAL TUBESCBI2010-03-11
1546831333611939K092634OBS DISPOSABLE ELECTROSURGICAL PENCILS, MODELS: OBS-DB, OBS-DR, OBS-DFGEI2009-12-01
1546832024517951K091516WELL LEAD SILICONE CATHETER WITH TEMPERATURE SENSOREZL2009-10-16
1546831679473402K083687BAIXIN INTRAVASCULAR ADMINISTRATION SETFPA2009-06-11
1546831704221166K083429I.V. CATHETER, MODELS: TYPE I, TYPE Y, TYPE STRAIGHTFOZ2009-08-07
1546831650705880K082815WELL LEAD SILICONE AND LATEX FOLEY CATHETERSEZL2008-10-08
1546831388901649K082439DISPOSABLE ANGIOGRAPHIC SYRINGE, MODEL(S) CT-200-NE, CT-200-MA, CT-200+200-MA, CT-200-LF, CT -100-NE, CT-200NE, CT-50+CTDXT2009-03-23
1546831433362342K080684WG-SURGICAL SUTURES WITH NEEDLEGAP2008-06-09
1546831224813831K073614WG-SURGICAL SUTURES WITH NEEDLENEW2008-04-30
1546831403416607K073383WELL LEAD REINFORCED ENDOTRACHEAL TUBEBTR2008-07-10
1546831602669815K073127BLOOD COLLECTION NEEDLE, MODEL 20G 21G 22GFMI2007-12-20
1546832050489939K072739JIERUI SYRINGES AND NEEDLESMEG2008-03-21
1546831126641369K070451ABLE CENTRAL VENOUS CATHETERFOZ2007-07-31
1546832043237982K060211WUZHOU SYRINGE, WITH/WITHOUT NEEDLEFMF2006-02-10
1546831058812378K060018TRULENE MESHFTL2006-07-26
1546831723336799K053236DAVID PREGNANCY TEST (MIDSTREAM)LCX2006-07-18
1546831591635460K043443ONE STEP HCG URINE PREGNANCY TESTLCX2005-04-08
1546831334456329K042684WELL LEAD TRACHEOSTOMY TUBEBTO2005-02-17
1546831682785951K042683WELL LEAD ENDOTRACHEAL TUBEBTR2005-02-18
1546831788101326K040176MAXTER POWDER FREE NITRILE MEDICAL EXAMINATION GLOVESLZA2004-02-24
1546831705407359K033210BIOTEQ DOUBLE PIGTAIL URETERAL STENT SETFAD2004-12-30
1546831178218861K032501MAXTER STERILE POWDER FREE SURGICAL GLOVESKGO2003-10-17
1546831553383179K032467MAXTER STERILE POWDERED LATEX SURGICAL GLOVESKGO2003-10-10
1546831075601112K032292BIOTEQUE A.V. FISTULA NEEDLE SET WITH SAFETY FLEXFOZ2004-03-22
1546831454240024K022666PDO (POLYDIOXANONE) MONOFILAMENT SYNTHETIC ABSORBABLE SUTURE U.S.P.NEW2002-10-09
1546831455069913K022664PGA (POLYGLYCOLIC) SYNTHETIC ABSORBABLE SUTURE U.S.P.GAM2002-09-10
1546831678766827K013498CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)LYY2002-01-17
1546831302925103K013443POWDERED LATEX MEDICAL MEDICAL EXAMINATION GLOVES WITH 150 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER DM2LYY2001-11-29
1546831949044315K000714VACUFLOW+SAFE BLOOD COLLECTION SET AND VACUFLOW+SAFE WITH HOLDER BLOOD COLLECTION SETFMI2000-12-21
1546831721897908K000542PLAIN AND CHRONIC GUT ABSORBABLE SURGICAL SUTURES, USPGAL2000-04-28
1546831094936232K000541SILK NONABSORBABLE SURGICAL SUTURES, USPGAP2000-04-28
1546831795272937K000540POLYESTER NONABSORBABLE SURGICAL SUTURES, USPGAT2000-04-27
1546831849287246K000539NYLON NONABSORBABLE SURGICAL SUTURES, USPGAR2000-04-27
1546831051451340K000537POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES, USPGAW2000-04-27
1546831480677240K000369VACUFLOW+ BLOOD COLLECTION SET, MODEL 52221/3/5; VACUFLOW+ WITH HOLDER BLOOD COLLECTION SET, MODEL 82021/3/5 WITH HOLDERFMI2000-03-30
1546831118431713
1546831011197579
1546831014583533
1546831020983139
1546831033389738
1546831037329416
1546831038613677
1546831050440718
1546831065967921
1546831067756979
1546831070157743
1546831079441079
1546831087545793
1546831104460843
1546831105025717
1546831126022495
1546831131196203
1546831136898092
1546831139111415
1546831144336722
1546831178260730
1546831199138400
1546831266156426
1546831269481175
1546831280286765
1546831283645202
1546831286725567
1546831287906574

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FMI62022-11-04
JKA52023-03-24
FOZ52020-04-23
LKF42011-12-15
MEG32021-10-18
EZL32020-12-15
GAM32014-01-14
GDW32013-07-05
FMF32011-12-14
BTR32011-08-26
FMK22022-10-28
FXX22016-06-15
CAF22015-01-08
GEI22010-11-03
GAP22008-06-09
NEW22008-04-30
LCX22006-07-18
KGO22003-10-17
LYY22002-01-17
FYA12019-01-16
PIF12018-07-12
PNR12016-09-22
DQO12015-03-20
MAV12014-12-12
CAH12014-07-30
DYB12014-02-03
GTY12014-01-31
KNA12014-01-10
LOX12013-08-13
HDX12013-08-08
DIO12013-07-31
BSP12012-12-21
DQX12012-05-11
MPB12011-11-18
CGA12011-10-07
DXC12011-09-27
LDJ12011-05-20
FPD12011-05-13
NVP12011-01-28
HHK12010-07-26