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Data / Medical devices / Australia / EvERX PTY LTD

EvERX PTY LTD: FDA-registered device maker in Sydney New South Wales, Australia, 66 510(k) clearances and 2 PMA approvals

EvERX PTY LTD is registered with the FDA (registration 3008496839) in Sydney New South Wales, Australia. It lists 25 device types. The FDA files 66 510(k) clearances and 2 PMA approvals under its listings, the newest dated February 13, 2024. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch EvERX PTY LTD
FDA registration number
3008496839
Address
3 / 185 Briens Rd Northmead, Sydney New South Wales, Australia, 2152
Owner or operator
EverX / Bindra (10033159)
Roles
Exporter to the US
First device listed
April 28, 2016
Registered through
2026
Brand names listed
AUTOCAT2 WAVE INTRA AORTIC BALLOON PUMP, AVEA 17310 VENTILATOR, CAREFUSION AVEA VENTILATOR, DISCOVERY MODEL NM/CT 670, ENCOR BREAST BIOPSY SYSTEM, FUJI AMULETINNOVALITY DIGITAL BREAST TOMOSYNTHESIS, GE AMX4 Plus, GE BrightSpeed 16-Slice CT and more

Devices it lists

DeviceProduct codeClassRoleSource
Automated Radiological Image Processing SoftwareQIH2Exporter to the USaccessdata.fda.gov
Biopsy Needle Guide KitOIJ2Exporter to the USaccessdata.fda.gov
Catheter, Ultrasound, IntravascularOBJ2Exporter to the USaccessdata.fda.gov
Densitometer, BoneKGI2Exporter to the USaccessdata.fda.gov
Digital Breast TomosynthesisOTE3Exporter to the USaccessdata.fda.gov
Full Field Digital, System, X-Ray, MammographicMUE2Exporter to the USaccessdata.fda.gov
Image-Intensified Fluoroscopic X-Ray System, MobileOXO2Exporter to the USaccessdata.fda.gov
Instrument, BiopsyKNW2Exporter to the USaccessdata.fda.gov
Interventional Fluoroscopic X-Ray SystemOWB2Exporter to the USaccessdata.fda.gov
Solid State X-Ray Imager (Flat Panel/Digital Imager)MQB2Exporter to the USaccessdata.fda.gov
System, Balloon, Intra-Aortic And ControlDSP2Exporter to the USaccessdata.fda.gov
System, Image Processing, RadiologicalLLZ2Exporter to the USaccessdata.fda.gov
System, Imaging, Pulsed Doppler, UltrasonicIYN2Exporter to the USaccessdata.fda.gov
System, Imaging, Pulsed Echo, UltrasonicIYO2Exporter to the USaccessdata.fda.gov
System, Nuclear Magnetic Resonance ImagingLNH2Exporter to the USaccessdata.fda.gov
System, Tomography, Computed, EmissionKPS2Exporter to the USaccessdata.fda.gov
System, X-Ray, AngiographicIZI2Exporter to the USaccessdata.fda.gov
System, X-Ray, Fluoroscopic, Image-IntensifiedJAA2Exporter to the USaccessdata.fda.gov
System, X-Ray, MammographicIZH2Exporter to the USaccessdata.fda.gov
System, X-Ray, MobileIZL2Exporter to the USaccessdata.fda.gov
System, X-Ray, StationaryKPR2Exporter to the USaccessdata.fda.gov
System, X-Ray, TomographicIZF2Exporter to the USaccessdata.fda.gov
System, X-Ray, Tomography, ComputedJAK2Exporter to the USaccessdata.fda.gov
Transducer, Ultrasonic, DiagnosticITX2Exporter to the USaccessdata.fda.gov
Ventilator, Continuous, Facility UseCBK2Exporter to the USaccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
February 13, 2024K233788EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemIYNSubstantially EquivalentPhilips Ultrasound, LLCaccessdata.fda.gov
July 18, 2022K211720Planmed Clarity 2D, Planmed Clarify SMUESubstantially EquivalentPlanmed OYaccessdata.fda.gov
October 15, 2020K202683ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System, ACUSON Freestyle Diagnostic Ultrasound System,ACUSON S1000, S2000, S3000 Diagnostic Ultrasound Systems, ACUSON P200 Diagnostic Ultrasound System, ACUSON P500 Diagnostic Ultrasound System, ACUSON NX3, NX3 Elite Diagnostic Ultrasound SystemIYNSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
May 27, 2020K201112AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABPDSPSubstantially EquivalentArrow International, Inc.accessdata.fda.gov
May 1, 2020K200917Azurion R2.1OWBSubstantially EquivalentPhilips Medical Systems Nederland B.V.accessdata.fda.gov
June 7, 2017K170412Vantage Titan 1.5T, MRT-1510, M-Power GXLNHSubstantially EquivalentToshibamedical Systems Corporationaccessdata.fda.gov
April 11, 2017K170445LOGIQ S8IYNSubstantially EquivalentGE Healthcareaccessdata.fda.gov
September 6, 2016K162243ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound SystemIYNSubstantially EquivalentSiemens Medi Cal Solutions, Inc.accessdata.fda.gov
March 29, 2016K151252Puritan Bennett 840 Series Ventilator SystemCBKSubstantially EquivalentCovidien LPaccessdata.fda.gov
March 10, 2015K142465Aquilion ONE Vision, v7.0JAKSubstantially EquivalentToshibamedical Systems Corporationaccessdata.fda.gov
September 15, 2014K140912SOMATOM SCOPE/SOMATOM SCOPE POWERJAKSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
August 21, 2014K142006SYMBIA 6.0KPSSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
July 10, 2014K133819VERADIUSOWBSubstantially EquivalentPhilips Medical Systems Nederland B.V.accessdata.fda.gov
April 30, 2014K133590SOMATOM PERSPECTIVEJAKSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
September 26, 2013K131885SENOGRAPHE ESSENTIAL, PREMIUM VIEW I (PVI)MUESubstantially EquivalentGE Medical Systems SCSaccessdata.fda.gov
August 30, 2013K131576OPTIMA CT660JAKSubstantially EquivalentGe Medical Systems, LLCaccessdata.fda.gov
June 11, 2013K123520MAMMOMAT INSPIRATION PRIMEMUESubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
May 17, 2013K130885MAGNETOM AVANTO-FIT, MAGNETOM SKYRA-FITLNHSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
March 25, 2013K130173SONOSITE MAXX SERIES ULTRASOUND SYSTEMIYNSubstantially EquivalentFUJIFILM Sonosite, Inc.accessdata.fda.gov
February 22, 2013K122286MAMMOMAL INSPIRATIONMUESubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
February 8, 2013K123596OPTIMA CT520JAKSubstantially EquivalentGe Hangwei Medical Systems Co., Ltd.accessdata.fda.gov
January 29, 2013K123873CONTRAST ENHANCED DIGITAL MAMMOGRAPHYMUESubstantially EquivalentHologic, Inc.accessdata.fda.gov
January 2, 2013K122457GE INNOVA/INNOVA IGS/DISCOVERY IGS/OPTIMA ANGIOGRAPHIC, FLUOSCOPIC X-RAY SYSTEMS WITH CATHLAB FRONTIERS SOLUTIONSOWBSubstantially EquivalentGE Healthcareaccessdata.fda.gov
August 16, 2012K122234OEC 9900 ELITEOWBSubstantially EquivalentGe Healthcare Surgery GE Oec Medical Systems, Inc.accessdata.fda.gov
August 16, 2012K121422APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEMIYOSubstantially EquivalentToshiba Medical Systems Coporation, Japanaccessdata.fda.gov
June 12, 2012K120833DISCOVERY CT750 HDJAKSubstantially EquivalentGe Medical Systems, LLCaccessdata.fda.gov
May 23, 2012K120579SOMATOM DEFINITION EDGEJAKSubstantially EquivalentSiemens Medical Systems, Inc.accessdata.fda.gov
May 8, 2012K121072SOMATOM DEFINITION FLASHJAKSubstantially EquivalentSiemens Medical Systems, Inc.accessdata.fda.gov
April 19, 2012K121019OPTIMA NM/CT 640KPSSubstantially EquivalentGE Healthcareaccessdata.fda.gov
April 6, 2012K120710AQUILION PRIMEJAKSubstantially EquivalentToshibamedical Systems Corporationaccessdata.fda.gov
April 6, 2012K120388INSIGHT - FD MINI C-ARM FLUOROSCOPIC IMAGING SYSTEMOXOSubstantially EquivalentHologic, Inc.accessdata.fda.gov
January 13, 2012K113490OPTIMA MR450WLNHSubstantially EquivalentGe Medical Systems, LLCaccessdata.fda.gov
December 22, 2011K110798SENOGRAPHE DS, SENOGRAPHE ESSENTIALMUESubstantially EquivalentGeneral Electric Companyaccessdata.fda.gov
October 4, 2011K111551OEC(R) 9800, OEC(R) 9800 PLUSOWBSubstantially EquivalentGe Oec Medical Systems, Inc.accessdata.fda.gov
August 12, 2011K103448BRIVO XR385KPRSubstantially EquivalentGe Medical Systems, LLCaccessdata.fda.gov
July 20, 2011K110227OPTIMA CT660JAKSubstantially EquivalentGe Medical Systems, LLCaccessdata.fda.gov
May 12, 2011K103211AVEA VENTILATORCBKSubstantially EquivalentCare Fusionaccessdata.fda.gov
April 28, 2011K110025SECTRA MICRODOSE MAMMOGRAPHYMUESubstantially EquivalentSectra Imtec ABaccessdata.fda.gov
April 19, 2011K093581DISCOVERY MODEL CT590 RT AND OPTIMA MODEL CT580 CT SYSTEMSJAKSubstantially EquivalentGe Medical Systems, LLCaccessdata.fda.gov
October 1, 2010K101347MAGNETOM AERA; MAGNETOM SKYRALNHSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
December 10, 2009K093514DISCOVERY MODEL NM/CT 670KPSSubstantially EquivalentGe Medical Systems F.I. Haifaaccessdata.fda.gov
November 20, 2009K093512ENCOR BREAST BIOPSY SYSTEMKNWSubstantially EquivalentSenorx, Inc.accessdata.fda.gov
November 17, 2009K092271GE LOGIQ E9 BT2010 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL 5205000-3, 5205000-4IYNSubstantially EquivalentGE Healthcareaccessdata.fda.gov
December 22, 2008K081148SIEMENS ACUSON 2000 ULTRASOUND SYSTEM WITH ABVS TRANSDUCERIYOSubstantially EquivalentSiemens Medical Solutions USA, Inc., Ultrasound DIaccessdata.fda.gov
November 21, 2008K082506SYMBIA, VERSION 4.0KPSSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
October 8, 2008K082816GE BRIGHTSPEED DELIGHT CT SCANNER SYSTEMJAKSubstantially EquivalentGe Medical Systems, LLCaccessdata.fda.gov
October 8, 2008K082761GE LIGHTSPEED 7.2 CT SCANNER SYSTEMJAKSubstantially EquivalentGe Medical Systems, LLCaccessdata.fda.gov
June 12, 2008K081496OPTIMA PET/CT 560KPSSubstantially EquivalentGe Medical Systems, LLCaccessdata.fda.gov
June 2, 2008K081022SOMATOM DEFINITION, MODEL AS/AS+JAKSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
May 14, 2008K080701SHIMADZU MOBILE X-RAY SYSTEM MOBILEDART EVOLUTIONIZLSubstantially EquivalentShimadzu Corp.accessdata.fda.gov
March 14, 2008K080211MODEL TSX-101A/H/I AQUILION 32/64 SP CT SYSTEMJAKSubstantially EquivalentToshiba America Medical Systems, In.Caccessdata.fda.gov
February 11, 2008K073290ARTIS ZEE AND ZEEGOIZISubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
October 10, 2007K072237MAGNETOM VERIOLNHSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
August 9, 2005K051967REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH TOMOSYNTHESISKPRSubstantially EquivalentGE Healthcareaccessdata.fda.gov
June 1, 2005K051133ARCADIS AVANTICOXOSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
March 11, 2005K050489INNOVA 2100OWBSubstantially EquivalentGe Medical Systems, LLCaccessdata.fda.gov
March 1, 2005K050297SOMATOM EMOTION 16JAKSubstantially EquivalentSiemens Medical Solution, Inc. USAaccessdata.fda.gov
February 18, 2005K050199MAGNETOM SYMPHONY A TIM SYSTEMLNHSubstantially EquivalentSiemens Medical Solutionaccessdata.fda.gov
April 19, 2004K040125SENOGRAPHIC STEREOIZHSubstantially EquivalentGe Medical Systems, Inc.accessdata.fda.gov
February 12, 2004K040066SIREMOBILE C06OXOSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
November 6, 2002K022674BIRD AVEA VENTILATORCBKSubstantially EquivalentBird Products Corp.accessdata.fda.gov
September 19, 2002K022960GE QUASAR NUCLEAR MEDICINE SYSTEMKPSSubstantially EquivalentGe Medical Systems F.I. Haifaaccessdata.fda.gov
June 17, 2002K021016AMX-4 PLUS MOBILE X-RAY SYSTEMIZLSubstantially EquivalentGE Medical Systemsaccessdata.fda.gov
March 12, 2001K010435PHILIPS BV PULSERA/ENDURAOWBSubstantially EquivalentPhilips Medical Systems, Inc.accessdata.fda.gov
August 19, 1999K992506MINI 6800 DIGITAL MOBILE C-ARMOXOSubstantially EquivalentGe Dec Medical Systemsaccessdata.fda.gov
August 18, 1998K982267DPX-RX BONE DENSITOMETERKGISubstantially EquivalentLunar Corp.accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

ApprovedPMA numberDeviceProduct codeSupplementsLatest decisionSource
January 10, 2017P160031ASPIRE CRISTALLE DIGITAL BREAST TOMOSYNTHESIS OPTIONOTE4February 13, 2023accessdata.fda.gov
February 11, 2011P080003SELENIA DIMENSIONS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEMOTE10November 24, 2025accessdata.fda.gov

Compare with other makers

Updated February 13, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.