Everx Pty L T D

FDA Filings

This page includes the latest FDA filings for Everx Pty L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3008496839
• FEI Number: 3008496839
• Name: EvERX PTY LTD
• Owner & Operator: EverX / Bindra
• Contact Address: 3 / 185 Briens Rd Northmead; Sydney AU-NSW New South Wales 2152 AU
• Official Correspondent:
  • Ravinder S Bindra
  • 61-2-9683-4573
• US Agent:
  • Hamish Dunn
  • UDS
  • 530 2628382
  • hdunn@everxusa.com
• Importing Logistics Registration:
  • Importer: Engineering & Network Systems Inc
  • Address: 20871 Johnson Street Suite 111 Pembroke Pines ; Pembroke Pines, FL 33029 UNITED STATES
  • Email Address: john@bravoimaging.com
  • Phone: 1 954 3682399
  • Importer Type: Importer
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 3 / 185 Briens Rd Northmead; Sydney New South Wales, 2152 AU
• Establishment Type: Export Device to the United States But Perform No Other Operation on Device

FDA Filings

Device Company	Device	Date
PMN K081105 | JAK EvERX PTY LTD [EverX / Bindra]	GE 750HD CT Scanner	2020-04-01
PMN K050559 | KPS EvERX PTY LTD [EverX / Bindra]	GE VCT	2020-04-01
PMN K050559 | JAK EvERX PTY LTD [EverX / Bindra]	GE VCT	2020-04-01
PMN K051025 | JAA EvERX PTY LTD [EverX / Bindra]	FLUOROSCAN INSIGHT MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM	2020-02-11
PMN K050297 | JAK EvERX PTY LTD [EverX / Bindra]	Siemens Emotion 16	2019-11-06
PMN K151486 | KPS EvERX PTY LTD [EverX / Bindra]	Siemens Biograph PET CT	2019-07-30
PMN K151486 | JAK EvERX PTY LTD [EverX / Bindra]	Siemens Biograph PET CT	2019-07-30
PMN K123564 | IYO EvERX PTY LTD [EverX / Bindra]	GE Logiq E9	2019-04-17
PMN K123564 | IYN EvERX PTY LTD [EverX / Bindra]	GE Logiq E9	2019-04-17
PMN K123564 | ITX EvERX PTY LTD [EverX / Bindra]	GE Logiq E9	2019-04-17
PMN K081022 | JAK EvERX PTY LTD [EverX / Bindra]	Siemens Definition 128 Slice CT Scanner	2019-04-17
PMN K022960 | KPS EvERX PTY LTD [EverX / Bindra]	GE Infinia Hawkeye IV	2019-04-17
PMN K062742 | MQB EvERX PTY LTD [EverX / Bindra]	Agfa CR 85X	2019-03-27
PMN K031637 | OWB EvERX PTY LTD [EverX / Bindra]	GE Innova 3100	2019-03-18
PMN K031637 | JAA EvERX PTY LTD [EverX / Bindra]	GE Innova 3100	2019-03-18
PMN K950883 | IZO EvERX PTY LTD [EverX / Bindra]	Siemens Polydoros X-Ray	2018-12-20
PMN K113448 | KPS EvERX PTY LTD [EverX / Bindra]	Siemens Biograph	2018-12-17
PMN K113448 | JAK EvERX PTY LTD [EverX / Bindra]	Siemens Biograph	2018-12-17
PMN K060060 | KPS EvERX PTY LTD [EverX / Bindra]	Siemens Biograph 6	2018-12-17
PMN K060060 | JAK EvERX PTY LTD [EverX / Bindra]	Siemens Biograph 6	2018-12-17
PMN K043112 | LNH EvERX PTY LTD [EverX / Bindra]	GE Profile V	2018-12-13
PMN K951765 | OXO EvERX PTY LTD [EverX / Bindra]	GE OEC 6600	2018-11-20
PMN K131885 | MUE EvERX PTY LTD [EverX / Bindra]	GE Senograph Essentials Mamo	2018-11-20
PMN K053069 | IYO EvERX PTY LTD [EverX / Bindra]	Sonosite Micromax Ultrasound	2018-11-20
PMN K053069 | IYN EvERX PTY LTD [EverX / Bindra]	Sonosite Micromax Ultrasound	2018-11-20
PMN K053069 | ITX EvERX PTY LTD [EverX / Bindra]	Sonosite Micromax Ultrasound	2018-11-20
PMN K051133 | OXO EvERX PTY LTD [EverX / Bindra]	Siemens Arcadis Avantic	2018-11-20
PMN K033418 | JAK EvERX PTY LTD [EverX / Bindra]	Toshiba Aquilion 16 CT Scanner	2018-11-20
PMN K013522 | JAK EvERX PTY LTD [EverX / Bindra]	Siemens Sensation 16	2018-11-06
PMN K142955 | JAK EvERX PTY LTD [EverX / Bindra]	Siemens Sensation 16/64	2018-10-18
PMN K043076 | OXO EvERX PTY LTD [EverX / Bindra]	GE OEC FlouroStar 7900	2018-10-18
PMN K043076 | OWB EvERX PTY LTD [EverX / Bindra]	GE OEC FlouroStar 7900	2018-10-18
PMN K043076 | JAA EvERX PTY LTD [EverX / Bindra]	GE OEC FlouroStar 7900	2018-10-18
PMN K033326 | JAK EvERX PTY LTD [EverX / Bindra]	Philips Brilliance 64 CT Scanner	2018-08-20
PMN K082104 | JAK EvERX PTY LTD [EverX / Bindra]	Ge Lightspeed RT 16	2018-07-27
PMN K133424 | JAK EvERX PTY LTD [EverX / Bindra]	Siemens Emotion 16	2018-07-16
PMN K111551 | OXO EvERX PTY LTD [EverX / Bindra]	OEC 9800	2018-07-13
PMN K111551 | OWB EvERX PTY LTD [EverX / Bindra]	OEC 9800	2018-07-13
PMN K111551 | JAA EvERX PTY LTD [EverX / Bindra]	OEC 9800	2018-07-13
PMN K033881 | DXT EvERX PTY LTD [EverX / Bindra]	Stallant Injector	2018-07-13
PMN K030420 | JAK EvERX PTY LTD [EverX / Bindra]	GE Lightspeed 16	2018-07-13
PMN K023183 | DXT EvERX PTY LTD [EverX / Bindra]	Medrad CT Pressure Injector	2018-07-13
PMN K163077 | IYO EvERX PTY LTD [EverX / Bindra]	EverX Pty Ltd	2018-07-11
PMN K163077 | IYN EvERX PTY LTD [EverX / Bindra]	EverX Pty Ltd	2018-07-11
PMN K163077 | ITX EvERX PTY LTD [EverX / Bindra]	EverX Pty Ltd	2018-07-11
PMN K110227 | JAK EvERX PTY LTD [EverX / Bindra]	GE Optima 660 CT Scanner	2018-06-17
PMN K122234 | OXO EvERX PTY LTD [EverX / Bindra]	OEC 9900	2018-06-06
PMN K122234 | OWB EvERX PTY LTD [EverX / Bindra]	OEC 9900	2018-06-06
PMN K122234 | JAA EvERX PTY LTD [EverX / Bindra]	OEC 9900	2018-06-06
PMN K160632 | LNH EvERX PTY LTD [EverX / Bindra]	Toshiba Titan 1.5T MRI	2018-05-15
PMN K092079 | IYO EvERX PTY LTD [EverX / Bindra]	GE Vivid S6	2018-05-15
PMN K092079 | IYN EvERX PTY LTD [EverX / Bindra]	GE Vivid S6	2018-05-15
PMN K092079 | ITX EvERX PTY LTD [EverX / Bindra]	GE Vivid S6	2018-05-15
PMN K091374 | IYO EvERX PTY LTD [EverX / Bindra]	GE Logiq e	2018-05-15
PMN K091374 | IYN EvERX PTY LTD [EverX / Bindra]	GE Logiq e	2018-05-15
PMN K091374 | ITX EvERX PTY LTD [EverX / Bindra]	GE Logiq e	2018-05-15
PMN K061682 | IYO EvERX PTY LTD [EverX / Bindra]	GE Voluson E8	2018-05-15
PMN K061682 | IYN EvERX PTY LTD [EverX / Bindra]	GE Voluson E8	2018-05-15
PMN K061682 | ITX EvERX PTY LTD [EverX / Bindra]	GE Voluson E8	2018-05-15
PMN K002003 | IYO EvERX PTY LTD [EverX / Bindra]	ATL HDI 5000	2018-04-17
PMN K002003 | IYN EvERX PTY LTD [EverX / Bindra]	ATL HDI 5000	2018-04-17
PMN K002003 | ITX EvERX PTY LTD [EverX / Bindra]	ATL HDI 5000	2018-04-17
PMN K993090 | KPR EvERX PTY LTD [EverX / Bindra]	GE Proteus X-Ray DR	2018-04-10
PMN K052331 | IYO EvERX PTY LTD [EverX / Bindra]	Siemens Acuson Cypress	2018-04-10
PMN K052331 | IYN EvERX PTY LTD [EverX / Bindra]	Siemens Acuson Cypress	2018-04-10
PMN K052331 | ITX EvERX PTY LTD [EverX / Bindra]	Siemens Acuson Cypress	2018-04-10
PMN K041688 | IYO EvERX PTY LTD [EverX / Bindra]	GE Voluson 730 Expert	2018-04-10
PMN K041688 | IYN EvERX PTY LTD [EverX / Bindra]	GE Voluson 730 Expert	2018-04-10
PMN K041688 | ITX EvERX PTY LTD [EverX / Bindra]	GE Voluson 730 Expert	2018-04-10
PMN K021016 | IZL EvERX PTY LTD [EverX / Bindra]	GE AMX 4Plus X-Ray	2018-04-10
PMN K003837 | OXO EvERX PTY LTD [EverX / Bindra]	GE OEC 8800	2018-03-12
PMN K003837 | JAA EvERX PTY LTD [EverX / Bindra]	GE OEC 8800	2018-03-12
PMN K082816 | JAK EvERX PTY LTD [EverX / Bindra]	GE Brightspeed Series CT Scanner	2018-03-11
PMN K033737 | OWB EvERX PTY LTD [EverX / Bindra]	Philips Allura Xper FD20	2018-03-11
PMN K033737 | JAA EvERX PTY LTD [EverX / Bindra]	Philips Allura Xper FD20	2018-03-11
PMN K033737 | IZI EvERX PTY LTD [EverX / Bindra]	Philips Allura Xper FD20	2018-03-11
PMN K110066 | JAK EvERX PTY LTD [EverX / Bindra]	TSX-302A, Aquilion Prime CT System	2018-02-25
PMN K041543 | KPS EvERX PTY LTD [EverX / Bindra]	GE Discovery PETCT	2018-01-08
PMN K041543 | JAK EvERX PTY LTD [EverX / Bindra]	GE Discovery PETCT	2018-01-08
PMN K021021 | JAA EvERX PTY LTD [EverX / Bindra]	Siemens Axiom Artis dTA	2017-12-12
PMN K021021 | IZI EvERX PTY LTD [EverX / Bindra]	Siemens Axiom Artis dTA	2017-12-12
PMN K091164 | IYO EvERX PTY LTD [EverX / Bindra]	GE VENUE 40 ultrasound	2017-11-13
PMN K091164 | IYN EvERX PTY LTD [EverX / Bindra]	GE VENUE 40 ultrasound	2017-11-13
PMN K091164 | ITX EvERX PTY LTD [EverX / Bindra]	GE VENUE 40 ultrasound	2017-11-13
PMN K121699 | IYO EvERX PTY LTD [EverX / Bindra]	Siemens X300	2017-11-06
PMN K121699 | IYN EvERX PTY LTD [EverX / Bindra]	Siemens X300	2017-11-06
PMN K121699 | ITX EvERX PTY LTD [EverX / Bindra]	Siemens X300	2017-11-06
PMN K121699 | DQO EvERX PTY LTD [EverX / Bindra]	Siemens X300	2017-11-06
PMN K110943 | IYO EvERX PTY LTD [EverX / Bindra]	GE Ligiq E9	2017-11-06
PMN K110943 | IYN EvERX PTY LTD [EverX / Bindra]	GE Ligiq E9	2017-11-06
PMN K110943 | ITX EvERX PTY LTD [EverX / Bindra]	GE Ligiq E9	2017-11-06
PMN K110870 | IYO EvERX PTY LTD [EverX / Bindra]	Toshiba Aplio	2017-11-06
PMN K110870 | IYN EvERX PTY LTD [EverX / Bindra]	Toshiba Aplio	2017-11-06
PMN K110870 | ITX EvERX PTY LTD [EverX / Bindra]	Toshiba Aplio	2017-11-06
PMN K082142 | IYO EvERX PTY LTD [EverX / Bindra]	ACUSON S2000	2017-11-06
PMN K082142 | IYN EvERX PTY LTD [EverX / Bindra]	ACUSON S2000	2017-11-06
PMN K082142 | ITX EvERX PTY LTD [EverX / Bindra]	ACUSON S2000	2017-11-06
PMN K072918 | IYO EvERX PTY LTD [EverX / Bindra]	Toshiba Xario XG	2017-11-06
PMN K072918 | IYN EvERX PTY LTD [EverX / Bindra]	Toshiba Xario XG	2017-11-06
PMN K072918 | ITX EvERX PTY LTD [EverX / Bindra]	Toshiba Xario XG	2017-11-06
PMN K072365 | IYO EvERX PTY LTD [EverX / Bindra]	Siemens SEQUOIA	2017-11-06
PMN K072365 | IYN EvERX PTY LTD [EverX / Bindra]	Siemens SEQUOIA	2017-11-06
PMN K072365 | ITX EvERX PTY LTD [EverX / Bindra]	Siemens SEQUOIA	2017-11-06
PMN K061129 | IYO EvERX PTY LTD [EverX / Bindra]	GE Logiq 9	2017-11-06
PMN K061129 | IYN EvERX PTY LTD [EverX / Bindra]	GE Logiq 9	2017-11-06
PMN K061129 | ITX EvERX PTY LTD [EverX / Bindra]	GE Logiq 9	2017-11-06
PMN K052441 | IYO EvERX PTY LTD [EverX / Bindra]	GE Logiq 7	2017-11-06
PMN K052441 | IYN EvERX PTY LTD [EverX / Bindra]	GE Logiq 7	2017-11-06
PMN K052441 | ITX EvERX PTY LTD [EverX / Bindra]	GE Logiq 7	2017-11-06
PMN K042540 | IYO EvERX PTY LTD [EverX / Bindra]	Philips IU22	2017-11-06
PMN K042540 | IYN EvERX PTY LTD [EverX / Bindra]	Philips IU22	2017-11-06
PMN K042540 | ITX EvERX PTY LTD [EverX / Bindra]	Philips IU22	2017-11-06
PMN K023687 | JAK EvERX PTY LTD [EverX / Bindra]	Siemens Emotion 6	2017-11-06
PMN K093563 | IYO EvERX PTY LTD [EverX / Bindra]	Probe L12-5	2017-11-02
PMN K093563 | IYN EvERX PTY LTD [EverX / Bindra]	Probe L12-5	2017-11-02
PMN K093563 | ITX EvERX PTY LTD [EverX / Bindra]	Probe L12-5	2017-11-02
PMN K030455 | IYO EvERX PTY LTD [EverX / Bindra]	Probe L8-4	2017-11-02
PMN K030455 | IYO EvERX PTY LTD [EverX / Bindra]	Philips IE33	2017-11-02
PMN K030455 | IYN EvERX PTY LTD [EverX / Bindra]	Probe L8-4	2017-11-02
PMN K030455 | IYN EvERX PTY LTD [EverX / Bindra]	Philips IE33	2017-11-02
PMN K030455 | ITX EvERX PTY LTD [EverX / Bindra]	Probe L8-4	2017-11-02
PMN K030455 | ITX EvERX PTY LTD [EverX / Bindra]	Philips IE33	2017-11-02
PMN K120833 | JAK EvERX PTY LTD [EverX / Bindra]	CT750HD	2017-09-19
PMN K052293 | LNH EvERX PTY LTD [EverX / Bindra]	GE 3.OT Signa HDx MR System	2017-06-18
PMN K082761 | JAK EvERX PTY LTD [EverX / Bindra]	GE VCT 64	2016-04-28
PMN K082761 | JAK EvERX PTY LTD [EverX / Bindra]	CT Scanner	2016-04-28
PMN K962738 | KPS EvERX PTY LTD [EverX / Bindra]	GE Millenium MG Gamma Camera	2012-01-17
PMN K052434 | KPS EvERX PTY LTD [EverX / Bindra]	GE Infinia Hawkeye	2012-01-17
PMN K040665 | JAK EvERX PTY LTD [EverX / Bindra]	Siemens Sensation 64	2010-07-16

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020091730073	Yantian,China (Mainland) -> Long Beach, California	SIEMENS DEFINITON CT SCANNER H.S CODE: 9018.13.00 FREIGHT PREPAID	4 CRT
2020082721514	Sydney,Australia -> Long Beach, California	MEDICAL EQUIPMENT	17 PCS
202007062588	Sydney,Australia -> Long Beach, California	MEDICAL EQUIPMENT	14 PCS
202005294743	Tauranga,New Zealand -> Charleston, South Carolina	1. PHILIPS MX16 CT SCANNER P ARTS AND COMPONENETS BRILL IANCE 16 BIG BORE CT SCANNER PARTS AND COMPONENTS FREIGHT PREPAID	2 PCS
2020052312948	Tauranga,New Zealand -> Charleston, South Carolina	1. PHILIPS MX16 CT SCANNER P ARTS AND COMPONENETS ONLY BRILLIANCE 16 BIG BORE CT S CANNER PARTS AND COMPONENTS FREIGHT PREPAID	2 PCS
2020051121541	Sydney,Australia -> Oakland, California	SCANNER GE OPTIMA 660 CT SCANNER C&F LA SEA PORT USA TERMS & CONDITIONS AS PER CONTRACT NO.01/CT-EVERX-NIS/2020	1 PCS
2020042313027	Yarraville,Australia -> Long Beach, California	SIEMENS AVANTO SIEMENS AVANTO 1.5T MRI EX1830	10 PCS
2020040910011	Sydney,Australia -> Long Beach, California	MEDICAL EQUIPMENT	23 PCS