FDA.reportPublic FDA data

Zvi Sklarz

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30110887433011088743Zvi Sklarz1N2026-01-01500 Davistown Rd Blackwood NJ US 08012
30185072993018507299Zvi Sklarz1N2026-01-0110203 Avenue D Brooklyn NY US 11236

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2966701839214687K993973FUJI II LC CAPSULEEBF2000-01-11
2966701899137300K992897IMPREGUM PENTAELW1999-09-08
1963441599455922K992734BECTON DICKINSON SYRINGEMEG1999-10-01
2966701876261447K9923263M CLINPRO SEALANTEBC1999-10-08
1963441052040013K991088VACUTAINER BRAND MULTIPLE SAMPLE LUER ADAPTER, BLOOD COLLECTION SETS AND SAFETY-LOK BLOOD COLLECTION, SAFETY BLOOD COLLEJKA1999-05-28
1963441661624033K990236MODIFICATION OF JELCO*,JELCO*-W AND JELCO* PLUS I.V. CATHETERS, CATHLON* I.V. CATHETERS, OPTIVA* I.V. CATHETERS, PROTECTFOZ1999-08-20
1963441644682001K9707963M RED DOT 2560 & 2570 MONITORING ELECTRODESDRX1997-04-09
2966701542613162K963735COJET SYSTEMEBF1996-11-27
2966701057318005K9627853M DENT SYSTEMKLE1996-08-12
2966701189808611K9620653M VITREBOND LIGHT CURE GLASS IONOMER/BASEEMA1996-07-18
2966701519707680K960954KETAC-MOLAR APLICAPEMA1996-05-16
1963441167151726K952861ANGIOCATH & INSYTE AUTOGUARD CATHETERSFOZ1995-07-31
1963441115268207K951254SAFETYGLIDE NEEDLEFMI1995-10-07
2966701175806694K951254SAFETYGLIDE NEEDLEFMI1995-10-07
2966701793819580K951123CAVICIDE SURFACE DISINFECTANT/DECONTAMINANT CLEANERLRJ1995-04-25
2966701982662414K950787WELCH ALLYN OTOSCOPEERA1995-04-06
1963441615142816K945952VACUTAINER(R) BRAND PLUS PST(TM) PLASMA SEPARATION TUBEJKA1995-01-18
2966701212547370K943642HERCULITE XR & XRVEBF1994-11-17
1963441619201199K942061DISPOSABLE SUCTION PROBEJOL1994-05-16
1963441708999379K936194COAXIAL BIOPSY NEEDLEFCG1994-03-22
1963442068519648K933751LIFESHIELD BLOOD COLLECTION DEVICEFMI1994-02-14
2966701802643113K924830LUXATEMP AUTOMIXEBG1994-04-29
1963441959760136K923090SAF-T HOLDER MULTI SAMPLE LUER ADAPTER W/ BLOODJKA1992-09-01
1963441843583501K922522MONOJECT SAFETY SYRINGE, 1 CC, 3CC AND 12 CC SIZESFMF1992-11-25
2966701061500049K920424SCOTCHBOND BRAND MULTI-PURPOSE ADHESIVE SYSTEMKLE1992-03-20
1963441947246213K914088BIVONA AIRE-CUF(R) PEDIATRIC TRACHEOSTOMY TUBEJOH1991-10-23
2966702000614507K900447DUODERM* ADHESIVE COMPRESSION BANDAGEKGX1990-04-13
2966701067780058K894219TEMP BOND NEEMA1989-09-18
2966701767399378K881422COE PAK AUTO MIX, REGULAR OR HARD SETEMA1988-10-31
2966701241934241K844846ESPE KETAC-CEM RADIOPAQUEEMA1985-03-25
1963441343002120K830710ARGYLE SILICONE SALEM SUMP TUBEKNT1983-03-29
2966701047502419K811291TEGADERM TRANSPARENT DRESSINGKGX1981-06-02
2966701781074603K811160SUR-FIT IRRIGATION SLEEVEEXD1981-06-02
1963441231865901K801343B-D FILTER NEEDLEFPB1980-06-20
1963441945913208K790366URINE CULTURE KITJTW1979-04-04
2966701902054915K243403BD Nexiva™ Closed IV Catheter SystemFOZ2025-07-25
1963441731554986K222744Sol-M Luer Lock SyringeFMF2022-10-11
1963441256331090K222478BD Vacutainer® Luer-Lok™ Access Device, BD Vacutainer® Blood Transfer DeviceJKA2023-03-10
1963441827558017K221327BD Alaris™ Pump Infusion SetsFPA2023-07-21
1963441750398176K220212BD Vacutainer® Push Button Blood Collection Set, BD Vacutainer® Push Button Blood Collection Set with Pre-Attached HolderJKA2023-03-24
1963441444236963K212724BD Vacutainer UltraTouch Push Button Blood Collection SetJKA2022-02-04
1963441877081366K212588Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida PTV Dilatation Catheter, Vida BAV Balloon Valvuloplasty CatheterDQY2022-05-04
2966701800060582K193217SensiCare PI and SensiCare PI Micro Surgical GlovesKGO2020-04-06
1963441114821015K191915SensiCare Sterile Power-Free Polymer Coated Polyisoprene Sugical Glove, Coated with Aloe VKGO2020-03-06
1963441233164542K183399BD Nexiva Closed IV Catheter SystemFOZ2019-03-20
1963441175118565K182582Oryum and Ovem Epidermal Deri Prick Test ApplicatorSCL2019-04-10
2966701220334899K182288TPH Spectra ST Flowable Composite RestorativeEBF2018-11-20
1963441739045152K180111ClearGuard HD Antimicrobial Barrier CapPEH2018-05-25
2966701605947608K173276Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USPFRO2018-07-02
1963441175795493K171953Bard Mission Disposable Core Biopsy InstrumentKNW2017-09-14
1963441020240963K162081BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse Hypodermic Needle, BD 1ml Luer-lok Insulin SyringeFMF2016-12-19
1963441059313244K153537Sol-M Insulin Syringe, Sol-M TB SyringeFMF2016-06-17
2966701909051397K143209SonicFill 2EBF2015-02-05
1963441080281773K141719BIOGEL PL MICRO SURGICAL GLOVEKGO2014-09-04
1963441188644983K133948BARD(R) MONOPTY(R) DISPOSABLE CORE BIOPSY INSTRUMENT, BARD(R) MAX-CORE(R) DISPOSABLE CORE INSTRUMENTKNW2014-02-21
2966701360076584K133948BARD(R) MONOPTY(R) DISPOSABLE CORE BIOPSY INSTRUMENT, BARD(R) MAX-CORE(R) DISPOSABLE CORE INSTRUMENTKNW2014-02-21
2966702005047020K131432CLEARFIL SE BOND 2 KIT; CLEARFIL SE BOND 2 VALUE PACK; CLEARFIL SE BOND 2 TRIAL PACK; CLEARFIL SE BOND 2 BOND; CLEARFILKLE2013-08-22
1963441928245252K120660CONQUEST 40 PTA DILATATION CATHETERLIT2012-03-15
1963441510591170K113700VIAVALVE SAFETY IV CATHETERFOZ2012-03-14
1963441574543602K111878PROTEXIS LATEX BLUE WITH NEU-THERA POWDER-FREE SURGICAL GLOVESKGO2011-09-29
1963441499904697K110771BD SINGLE USE, HYPODERMIC SYRINGEFMF2011-05-13
2966701507875863K103351DMC COMPOSITE 2EBF2011-01-20
1963441679550885K101180GRIPPER MICRO BLUNT CANNULA, NON-CORING SAFETY NEEDLE (GRIPPER MICRO NEEDLE) MODEL: 21-3253-24, 21-3258-24, 21-3262-24,FPA2010-08-03
2966701322301517K094007UNICEMEMA2010-04-08
2966701087135322K083610FILTEK SUPREME ULTRA UNIVERSAL RESTORATIVEEBF2008-12-17
2966701876793954K081229SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH SAF-HOLDER DEVICE, WITH 21G, 23G, 25G SAF-T WINGJKA2008-07-21
2966701653217568K080253KIMBERLY-CLARK INTRODUCER KITSKGC2008-02-26
1963441064615684K072657POWER PORT-A-CATH, CATH II, AND P.A.S. PORT T2 POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS AND POWER GRIPPER PLUSLJT2007-12-14
1963441894099105K072059GRIPPER MICRO NEEDLEFMI2007-11-01
1963441885717876K071785HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE, HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE WITH SYRINGEFMI2007-08-02
2966701893999067K071785HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE, HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE WITH SYRINGEFMI2007-08-02
2966701254666586K071742BEAUTIFIL IIEBF2007-08-15
1963441919292100K071565BIOGEL INDICATOR UNDERGLOVE WITH NON-PYROGENIC STATEMENTKGO2007-09-10
1963441960079687K050600MINILOC SAFETY INFUSION SETFPA2005-05-12
2966701596077093K043114KIMBERLY-CLARK MIC-KEY LOW PROFILE GASTROSTOMY TUBEKNT2004-12-10
1963441338304207K041399HYPODERMIC NEEDLE-PRO EDGE NEEDLE PROTECTION DEVICEFMI2004-07-28
1963441600542554K033666HEMADERMQSY2003-12-17
1963441358941329K032843NEXIVA CLOSED IV CATHETER SYSTEMFOZ2004-02-27
1963441948367879K032716PORTEX THERMOVENT HEPA HME BREATHING FILTER WITH CO2 PORT (STERILE AND NON-STERILE)CAH2003-11-28
2966701421260445K031444OPTIBOND FLKLE2003-07-02
1963441548131022K030573BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET, MODELS 367338, 367344, 367336, 367342, 367335, 367341JKA2003-05-08
1963441763190854K021999GRIPPER PLUS NEEDLEFPA2002-08-13
1963441463798468K013621BD SAF-T PRN LUER ACTIVATED VALVE, MODEL 385100FPA2002-04-16
1963441152409995K012736MONOJECT SAFETY NEEDLEFMI2001-10-25
1963441824641467K011721ESTEEM STERILE POLYISOPRENE SURGICAL GLOVESKGO2001-08-14
1963441400495318K002768ACAPELLABWF2000-12-05
2966701623274717K001730GC FUJICEMEMA2000-07-17
2966701824986243K001655PERMLASTIC 2ELW2000-08-10
1963441025027819
2966701112835842
1963441139000659
2966701211421087
1963441292865001
2966701488041403
1963441576976593
2966701602847625
1963441735609244
2966701877677290

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JKA82023-03-24
EBF82018-11-20
FMI82007-11-01
EMA72010-04-08
FOZ62025-07-25
KGO62020-04-06
FPA52023-07-21
FMF52022-10-11
KLE42013-08-22
KNW32017-09-14
KNT22004-12-10
ELW22000-08-10
KGX21990-04-13
DQY12022-05-04
SCL12019-04-10
FRO12018-07-02
PEH12018-05-25
LIT12012-03-15
KGC12008-02-26
LJT12007-12-14
QSY12003-12-17
CAH12003-11-28
BWF12000-12-05
EBC11999-10-08
MEG11999-10-01
DRX11997-04-09
LRJ11995-04-25
ERA11995-04-06
JOL11994-05-16
EBG11994-04-29
FCG11994-03-22
JOH11991-10-23
EXD11981-06-02
FPB11980-06-20
JTW11979-04-04