FDA.reportPublic FDA data

MAKAR CONSULTING PTY LTD

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30107039253010703925MAKAR CONSULTING PTY LTD1N2026-01-011 Garigal Road Belrose New South Wales AU 2085

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2398901973222423P990066GE HEALTHCARE SENOGRAPHE FULL FIELD DIGITAL MAMMOGRAPHY SYSTEMMUE2000-01-28
2398901832102375P080003SELENIA DIMENSIONS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEMOTE2011-02-11
2398901017822004P010025LORAD DIGITAL BREAST IMAGERMUE2002-03-15
2398901191821484K972367STRYKER SYSTEM 4000 HEAVY DUTY BATTERY POWERED EQUIPMENTKIJ1997-09-04
2398901266250673K261668Venue GoIYN2026-08-07
2398901887431117K243620Vivid iqIYN2025-02-11
2398901042320027K240111VenueIYN2024-06-10
2398901106665915K233539MAMMOMAT B.brilliantMUE2024-03-27
2398901619262159K231989LOGIQ E10s, LOGIQ FortisIYN2023-11-07
2398901470779820K220851VenueIYN2022-06-27
2398902029256881K220848Venue FitIYN2022-06-27
2398901841395963K220446Versana BalanceIYN2022-05-11
2398901260769900K214039LOGIQ P10, LOGIQ P9, LOGIQ P8IYN2022-03-22
2398901432267844K211524LOGIQ E10s, LOGIQ FortisIYN2021-08-27
2398901305487085K203114LOGIQ P10, LOGIQ P9, LOGIQ P8IYN2021-01-08
2398901789379160K202233Venue GoIYN2020-11-18
2398902066711782K201012EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound SystemIYN2020-05-01
2398901150688807K200743Vivid E80/ Vivid E90/ Vivid E95IYN2020-07-23
2398901686709827K193257ACUSON Sequoia Diagnostic Ultrasound SystemIYN2020-01-31
2398901341378220K191798Versana ActiveIYN2019-08-09
2398901707197206K191663Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0IYN2019-09-18
2398901020158081K181985Voluson E6, Voluson E8, Voluson E10IYN2018-11-15
2398901645962588K181727Vivid iqIYN2018-12-06
2398901605915746K181485EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound SystemIYN2018-07-27
2398901995612574K180017MX40 Release C.01MHX2018-07-24
2398901909725775K173555LOGIQ E10IYN2017-12-20
2398901622064803K173023Symbia T16, Symbia Intevo 16 and Symbia Intevo BoldKPS2017-11-17
2398901555082117K170904Biograph Horizon PET/CTKPS2017-06-01
2398901003477032K170752OEC EliteOWB2017-05-19
2398901796983214K162838Philips iCT CT SystemJAK2017-04-07
2398901654956503K161768LUCAS 3 Chest Compression SystemDRM2016-11-09
2398902051543226K161567SIGNA VoyagerLNH2016-09-01
2398901969385285K160743Philips Ingenuity CTJAK2016-08-08
2398901040446686K160621SIGNAPioneerLNH2016-03-29
2398901994943296K153486Affirm Prone Biopsy SystemIZH2016-04-01
2398901517465310K151765SOMATOM PerspectiveJAK2016-03-25
2398901186233065K150618PENTAX Medical EPK-i7010 Video Processor with GI FamilyPEA2015-11-24
2398901363464617K150087Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging System, Vivid E95 Diagnostic Ultrasound Imaging SystemIYN2015-03-04
2398901076902361K142955SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open, SOMATON Emotion 6/16, SOMATOM Sensation 64/Sensation Cardiac , SOMATOM Perspective SOMATOM Scope/ Scope PowerJAK2015-11-24
2398901005372841K133819VERADIUSOWB2014-07-10
2398901629740765K133664ENCORE VERSION 16 SOFTWARE FOR GE LUNAR DXA BONE DENSITOMETERSKGI2014-05-15
2398901538237197K132785STRYKER 1488 HD VIDEO CAMERA WITH INFRARED COMPATIBILITYGCJ2013-12-16
2398901280591792K132094CIOS ALPHAOWB2014-03-11
2398901651320203K131780EVIS EXERA III VIDEO SYSTEMFDF2013-08-29
2398901086612942K131634SYMBIAKPS2013-08-16
2398902037604001K131576OPTIMA CT660JAK2013-08-30
2398902065856898K130499IU22 DIAGNOSTIC ULTRASOUND SYSTEMIYN2013-06-18
2398901446847700K123873CONTRAST ENHANCED DIGITAL MAMMOGRAPHYMUE2013-01-29
2398901858912188K123596OPTIMA CT520JAK2013-02-08
2398901538780935K122445AESPIRE 7900, AESPIRE VIEWBSZ2012-10-12
2398901425449070K122286MAMMOMAL INSPIRATIONMUE2013-02-22
2398901317473992K120833DISCOVERY CT750 HDJAK2012-06-12
2398901197155432K120579SOMATOM DEFINITION EDGEJAK2012-05-23
2398901032343837K113598POWER-LOAD COT FASTENER SYSTEMFPO2011-12-20
2398901192081180K113125INTELLIVUE MX40 PATIENT MONITORDSI2011-11-17
2398901022744663K110798SENOGRAPHE DS, SENOGRAPHE ESSENTIALMUE2011-12-22
2398901340636871K103762SORIN C5 SYSTEM; 85/C5 MAST ROLLER PUMP SYSTEM 150(1X RP 150 AND CONTROL PANEL WITH CONNECTING CABLES); S5/C5 MAST ROLLEDTQ2011-01-20
2398901290358796K090422LUCAS 2DRM2009-06-17
2398901961490635K082937LIFEPAK 15 MONITOR/DEFIBRILLATORMKJ2009-03-11
2398901742380198K050297SOMATOM EMOTION 16JAK2005-03-01
2398901060158628K040372LIGHTSPEED 7.0 CT SCANNER SYSTEMJAK2004-03-01
2398901723491790K023398HOLOGIC QDR X-RAY BONE DENSITOMETER, MODELS 1000, 2000, 4500, DELPHI, DISCOVERYKGI2002-11-08
2398901100730634
2398901226046605

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
IYN222026-08-07
JAK102017-04-07
MUE62024-03-27
KPS32017-11-17
OWB32017-05-19
DRM22016-11-09
LNH22016-09-01
KGI22014-05-15
MHX12018-07-24
IZH12016-04-01
PEA12015-11-24
GCJ12013-12-16
FDF12013-08-29
BSZ12012-10-12
FPO12011-12-20
DSI12011-11-17
OTE12011-02-11
DTQ12011-01-20
MKJ12009-03-11
KIJ11997-09-04