Imedicom Co L T D

FDA Filings

This page includes the latest FDA filings for Imedicom Co 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: 3009599228
• FEI Number: 3009599228
• Name: Priscilla Chung
• Owner & Operator: IMEDICOM Co., Ltd.
• Contact Address: #612, 172, LS-ro ; Gunpo-si KR-41 Gyeonggido 435824 KR
• Official Correspondent:
  • Don Soo Joo
  • 82-31-4791156-x
• US Agent:
  • Priscilla Chung
  • 714 2025789
  • 714 4093357
  • juhee.c@lkconsultinggroup.com
• Importing Logistics Registration:
  • Importer: Basseler U.S.A. Medical
  • Address: One Brasseler Boulevard ; Savannah, GA 31419 UNITED STATES
• Importing Logistics Registration:
  • Importer: Blanca and Mili Alarcon
  • Address: 9801 S Cage Blvd, Suite 5, PMB 346 ; Pharr, TX 78577 UNITED STATES
  • Importer Type: AGENT
• Importing Logistics Registration:
  • Importer: Contract Medical Manufacturing, LLC
  • Address: 1 Jacks Hill Road, Suite 3E ; Oxford, CT 06478 UNITED STATES
  • Importer Type: AGENT
• Importing Logistics Registration:
  • Importer: Dio Medical
  • Address: 8770 W. Bryn Mawr Ave. Suite 1250 ; Chicago, IL 60631 UNITED STATES
• Importing Logistics Registration:
  • Importer: FG Corp
  • Address: 14110 Dallas Pkwy Ste 135 ; Dallas, TX 75254 UNITED STATES
• Importing Logistics Registration:
  • Importer: JOEL MARTINEZ FANNIE MARTINEZ
  • Address: 1906 Flora Ave ; Hidalgo, TX 78557 UNITED STATES
  • Importer Type: AGENT
• Importing Logistics Registration:
  • Importer: JUSTMS
  • Address: 15 Winthrop St ; Norwood, NJ 07648 UNITED STATES
• Importing Logistics Registration:
  • Importer: Orrexmedical
  • Address: 3550 Bandera Highway ; Kerrville, TX 78028 UNITED STATES
• Importing Logistics Registration:
  • Importer: Qualgenix, LLC
  • Address: 25 Depot Hill Road Building One, Suite 104 ; Southbury, CT 06488 UNITED STATES
  • Importer Type: AGENT
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 20 Sweet Shade ; Irvine, CA 92606 US
• Establishment Type:
  • Manufacture Medical Device
  • Export Device to the United States But Perform No Other Operation on Device

FDA Filings

Device Company	Device	Date
GUDID 08800038055605 IMEDICOM CO., LTD.	MEDINAUT MAX Pro	2024-04-23
GUDID 08800038059245 IMEDICOM CO., LTD.	SYNTH™ PLUS	2024-04-02
GUDID 08800038059238 IMEDICOM CO., LTD.	SYNTH™ PLUS	2024-04-02
GUDID 08800038059221 IMEDICOM CO., LTD.	SYNTH™ PLUS	2024-04-02
GUDID 08800038059214 IMEDICOM CO., LTD.	SYNTH™ PLUS	2024-04-02
GUDID 08800038059207 IMEDICOM CO., LTD.	SYNTH™ PLUS	2024-04-02
GUDID 08800038059191 IMEDICOM CO., LTD.	SYNTH™ PLUS	2024-04-02
GUDID 08800038059184 IMEDICOM CO., LTD.	SYNTH™ PLUS	2024-04-02
GUDID 08800038059177 IMEDICOM CO., LTD.	SYNTH™ PLUS	2024-04-02
GUDID 08800038059160 IMEDICOM CO., LTD.	SYNTH™ PLUS	2024-04-02
GUDID 08800038059153 IMEDICOM CO., LTD.	SYNTH™ PLUS	2024-04-02
GUDID 08800038059146 IMEDICOM CO., LTD.	SYNTH™ PLUS	2024-04-02
GUDID 08800038059139 IMEDICOM CO., LTD.	SYNTH™ PLUS	2024-04-02
GUDID 08800038059122 IMEDICOM CO., LTD.	SYNTH™ PLUS	2024-04-02
GUDID 08800038059115 IMEDICOM CO., LTD.	SYNTH™ PLUS	2024-04-02
GUDID 08800038059108 IMEDICOM CO., LTD.	SYNTH™ PLUS	2024-04-02
GUDID 08800038059092 IMEDICOM CO., LTD.	SYNTH™ PLUS	2024-04-02
GUDID 08800038059085 IMEDICOM CO., LTD.	SYNTH™ PLUS	2024-04-02
GUDID 08800038059078 IMEDICOM CO., LTD.	SYNTH™ PLUS	2024-04-02
GUDID 08800038059061 IMEDICOM CO., LTD.	SYNTH™ PLUS	2024-04-02
GUDID 08800038059054 IMEDICOM CO., LTD.	SYNTH™ PLUS	2024-04-02
GUDID 08800038059047 IMEDICOM CO., LTD.	SYNTH™ PLUS	2024-04-02
GUDID 08800038059030 IMEDICOM CO., LTD.	SYNTH™ PLUS	2024-04-02
GUDID 08800038059023 IMEDICOM CO., LTD.	SYNTH™ PLUS	2024-04-02
GUDID 08800038059016 IMEDICOM CO., LTD.	SYNTH™ PLUS	2024-04-02
GUDID 08800038059009 IMEDICOM CO., LTD.	SYNTH™ PLUS	2024-04-02
GUDID 08800038058996 IMEDICOM CO., LTD.	SYNTH™ PLUS	2024-04-02
GUDID 08800038058989 IMEDICOM CO., LTD.	SYNTH™ PLUS	2024-04-02
GUDID 08800038058972 IMEDICOM CO., LTD.	SYNTH™ PLUS	2024-04-02
GUDID 08800038058965 IMEDICOM CO., LTD.	SYNTH™ PLUS	2024-04-02
GUDID 08800038058958 IMEDICOM CO., LTD.	SYNTH™ PLUS	2024-04-02
GUDID 08800038058941 IMEDICOM CO., LTD.	SYNTH™ PLUS	2024-04-02
GUDID 08800038058934 IMEDICOM CO., LTD.	SYNTH™ PLUS	2024-04-02
GUDID 08800038058927 IMEDICOM CO., LTD.	SYNTH™ PLUS	2024-04-02
GUDID 08800038058910 IMEDICOM CO., LTD.	SYNTH™ PLUS	2024-04-02
GUDID 08800038058903 IMEDICOM CO., LTD.	SYNTH™ PLUS	2024-04-02
GUDID 08800038058897 IMEDICOM CO., LTD.	SYNTH™ PLUS	2024-04-02
GUDID 08800038058880 IMEDICOM CO., LTD.	SYNTH™ PLUS	2024-04-02
GUDID 08800038058873 IMEDICOM CO., LTD.	SYNTH™ PLUS	2024-04-02
GUDID 08800038058866 IMEDICOM CO., LTD.	SYNTH™ PLUS	2024-04-02
GUDID 08800038058859 IMEDICOM CO., LTD.	SYNTH™ PLUS	2024-04-02
GUDID 08800038058842 IMEDICOM CO., LTD.	SYNTH™ PLUS	2024-04-02
GUDID 08800038058835 IMEDICOM CO., LTD.	SYNTH™ PLUS	2024-04-02
GUDID 08800038058828 IMEDICOM CO., LTD.	SYNTH™ PLUS	2024-04-02
GUDID 08800038058811 IMEDICOM CO., LTD.	SYNTH™ PLUS	2024-04-02
GUDID 08800038058804 IMEDICOM CO., LTD.	SYNTH™ PLUS	2024-04-02
GUDID 08800038058798 IMEDICOM CO., LTD.	SYNTH™ PLUS	2024-04-02
GUDID 08800038058781 IMEDICOM CO., LTD.	SYNTH™ PLUS	2024-04-02
GUDID 08800038058774 IMEDICOM CO., LTD.	SYNTH™ PLUS BILATERAL	2024-04-02
GUDID 08800038058767 IMEDICOM CO., LTD.	SYNTH™ PLUS BILATERAL	2024-04-02
GUDID 08800038058750 IMEDICOM CO., LTD.	SYNTH™ PLUS BILATERAL	2024-04-02
GUDID 08800038058743 IMEDICOM CO., LTD.	SYNTH™ PLUS BILATERAL	2024-04-02
GUDID 08800038058736 IMEDICOM CO., LTD.	SYNTH™ PLUS BILATERAL	2024-04-02
GUDID 08800038058729 IMEDICOM CO., LTD.	SYNTH™ PLUS BILATERAL	2024-04-02
GUDID 08800038058712 IMEDICOM CO., LTD.	SYNTH™ PLUS BILATERAL	2024-04-02
GUDID 08800038058705 IMEDICOM CO., LTD.	SYNTH™ PLUS BILATERAL	2024-04-02
GUDID 08800038058699 IMEDICOM CO., LTD.	SYNTH™ PLUS BILATERAL	2024-04-02
GUDID 08800038058682 IMEDICOM CO., LTD.	SYNTH™ PLUS BILATERAL	2024-04-02
GUDID 08800038058675 IMEDICOM CO., LTD.	SYNTH™ PLUS BILATERAL	2024-04-02
GUDID 08800038058668 IMEDICOM CO., LTD.	SYNTH™ PLUS BILATERAL	2024-04-02
GUDID 08800038058651 IMEDICOM CO., LTD.	SYNTH™ PLUS BILATERAL	2024-04-02
GUDID 08800038058644 IMEDICOM CO., LTD.	SYNTH™ PLUS BILATERAL	2024-04-02
GUDID 08800038058637 IMEDICOM CO., LTD.	SYNTH™ PLUS BILATERAL	2024-04-02
GUDID 08800038058620 IMEDICOM CO., LTD.	SYNTH™ PLUS BILATERAL	2024-04-02
GUDID 08800038058613 IMEDICOM CO., LTD.	SYNTH™ PLUS BILATERAL	2024-04-02
GUDID 08800038058606 IMEDICOM CO., LTD.	SYNTH™ PLUS BILATERAL	2024-04-02
GUDID 08800038058590 IMEDICOM CO., LTD.	SYNTH™ PLUS BILATERAL	2024-04-02
GUDID 08800038058583 IMEDICOM CO., LTD.	SYNTH™ PLUS BILATERAL	2024-04-02
GUDID 08800038058576 IMEDICOM CO., LTD.	SYNTH™ PLUS BILATERAL	2024-04-02
GUDID 08800038058569 IMEDICOM CO., LTD.	SYNTH™ PLUS BILATERAL	2024-04-02
GUDID 08800038058552 IMEDICOM CO., LTD.	SYNTH™ PLUS BILATERAL	2024-04-02
GUDID 08800038058545 IMEDICOM CO., LTD.	SYNTH™ PLUS BILATERAL	2024-04-02
GUDID 08800038058538 IMEDICOM CO., LTD.	SYNTH™ PLUS BILATERAL	2024-04-02
GUDID 08800038058521 IMEDICOM CO., LTD.	SYNTH™ PLUS BILATERAL	2024-04-02
GUDID 08800038058514 IMEDICOM CO., LTD.	SYNTH™ PLUS BILATERAL	2024-04-02
GUDID 08800038058507 IMEDICOM CO., LTD.	SYNTH™ PLUS BILATERAL	2024-04-02
GUDID 08800038058491 IMEDICOM CO., LTD.	SYNTH™ PLUS BILATERAL	2024-04-02
GUDID 08800038058484 IMEDICOM CO., LTD.	SYNTH™ PLUS BILATERAL	2024-04-02
GUDID 08800038058477 IMEDICOM CO., LTD.	SYNTH™ PLUS BILATERAL	2024-04-02
GUDID 08800038058460 IMEDICOM CO., LTD.	SYNTH™ PLUS BILATERAL	2024-04-02
GUDID 08800038058453 IMEDICOM CO., LTD.	SYNTH™ PLUS BILATERAL	2024-04-02
GUDID 08800038058446 IMEDICOM CO., LTD.	SYNTH™ PLUS BILATERAL	2024-04-02
GUDID 08800038058439 IMEDICOM CO., LTD.	SYNTH™ PLUS BILATERAL	2024-04-02
GUDID 08800038058422 IMEDICOM CO., LTD.	SYNTH™ PLUS BILATERAL	2024-04-02
GUDID 08800038058415 IMEDICOM CO., LTD.	SYNTH™ PLUS BILATERAL	2024-04-02
GUDID 08800038058408 IMEDICOM CO., LTD.	SYNTH™ PLUS BILATERAL	2024-04-02
GUDID 08800038058392 IMEDICOM CO., LTD.	SYNTH™ PLUS BILATERAL	2024-04-02
GUDID 08800038058385 IMEDICOM CO., LTD.	SYNTH™ PLUS BILATERAL	2024-04-02
GUDID 08800038058378 IMEDICOM CO., LTD.	SYNTH™ PLUS BILATERAL	2024-04-02
GUDID 08800038058361 IMEDICOM CO., LTD.	SYNTH™ PLUS BILATERAL	2024-04-02
GUDID 08800038058354 IMEDICOM CO., LTD.	SYNTH™ PLUS BILATERAL	2024-04-02
GUDID 08800038058347 IMEDICOM CO., LTD.	SYNTH™ PLUS BILATERAL	2024-04-02
GUDID 08800038058330 IMEDICOM CO., LTD.	SYNTH™ PLUS BILATERAL	2024-04-02
GUDID 08800038058323 IMEDICOM CO., LTD.	SYNTH™ PLUS BILATERAL	2024-04-02
GUDID 08800038058316 IMEDICOM CO., LTD.	SYNTH™ PLUS BILATERAL	2024-04-02
GUDID 08800038058309 IMEDICOM CO., LTD.	SYNTH™ PLUS	2024-04-02
GUDID 08800038058293 IMEDICOM CO., LTD.	SYNTH™ PLUS	2024-04-02
GUDID 08800038058286 IMEDICOM CO., LTD.	SYNTH™ PLUS	2024-04-02
GUDID 08800038058279 IMEDICOM CO., LTD.	SYNTH™ PLUS	2024-04-02
GUDID 08800038058262 IMEDICOM CO., LTD.	SYNTH™ PLUS	2024-04-02
HWE Priscilla Chung [IMEDICOM Co., Ltd.]	Xtrat-P	2019-11-05
HWE Priscilla Chung [IMEDICOM Co., Ltd.]	EZX	2019-11-05
HWE Priscilla Chung [IMEDICOM Co., Ltd.]	EZX Blade	2019-11-05
PMN K182287 | NDN Priscilla Chung [IMEDICOM Co., Ltd.]	MEDINAUT Plus	2019-04-09
PMN K182287 | HXG Priscilla Chung [IMEDICOM Co., Ltd.]	MEDINAUT Plus	2019-04-09
PMN K182287 | HRX Priscilla Chung [IMEDICOM Co., Ltd.]	MEDINAUT Plus	2019-04-09
PMN K182287 Imedicom Co., Ltd.	MEDINAUT Plus	2019-04-06
PMN K173541 | BSO Priscilla Chung [IMEDICOM Co., Ltd.]	EPINAUT	2018-09-07
PMN K173541 Imedicom Co., Ltd.	EPINAUT	2018-08-24
PMN K103433 | NDN Priscilla Chung [IMEDICOM Co., Ltd.]	MVX Plus	2017-03-07
PMN K043593 | NDN Priscilla Chung [IMEDICOM Co., Ltd.]	MVX US	2017-03-07
GEN Priscilla Chung [IMEDICOM Co., Ltd.]	SPINAUT-F	2017-01-25
PMN K151268 | HRX Priscilla Chung [IMEDICOM Co., Ltd.]	SPINAUT-V	2016-12-13
PMN K151268 | HRX Priscilla Chung [IMEDICOM Co., Ltd.]	SPINAUT-S	2016-12-13
PMN K151268 | HRX Priscilla Chung [IMEDICOM Co., Ltd.]	SPINAUT-I	2016-12-13
PMN K150915 | GEI Priscilla Chung [IMEDICOM Co., Ltd.]	SPINAUT-P	2016-12-13
PMN K150789 | BSO Priscilla Chung [IMEDICOM Co., Ltd.]	SPINAUT-E	2016-12-13
PMN K153296 | NDN Priscilla Chung [IMEDICOM Co., Ltd.]	MEDINAUT-X	2016-09-06
PMN K153296 | NDN Priscilla Chung [IMEDICOM Co., Ltd.]	MEDINAUT-Ix	2016-09-06
PMN K153296 | NDN Priscilla Chung [IMEDICOM Co., Ltd.]	MEDINAUT-I	2016-09-06
PMN K153296 | NDN Priscilla Chung [IMEDICOM Co., Ltd.]	MEDINAUT Kyphoplasty System	2016-09-06
PMN K153296 | NDN Priscilla Chung [IMEDICOM Co., Ltd.]	B-Two Vertebral access system	2016-09-06
PMN K153296 | NDN Priscilla Chung [IMEDICOM Co., Ltd.]	B-Two Vertebral Balloon Expand? Kyphoplasty System	2016-09-06
PMN K153296 | NDN Priscilla Chung [IMEDICOM Co., Ltd.]	B-Two Inflatable bone expander system syringe	2016-09-06
PMN K153296 | NDN Priscilla Chung [IMEDICOM Co., Ltd.]	B-Two Inflatable bone expander system baloon catheter	2016-09-06
PMN K153296 | HRX Priscilla Chung [IMEDICOM Co., Ltd.]	MEDINAUT-X	2016-09-06
PMN K153296 | HRX Priscilla Chung [IMEDICOM Co., Ltd.]	MEDINAUT-Ix	2016-09-06
PMN K153296 | HRX Priscilla Chung [IMEDICOM Co., Ltd.]	MEDINAUT-I	2016-09-06
PMN K153296 | HRX Priscilla Chung [IMEDICOM Co., Ltd.]	MEDINAUT Kyphoplasty System	2016-09-06
PMN K153296 | HRX Priscilla Chung [IMEDICOM Co., Ltd.]	B-Two Vertebral access system	2016-09-06
PMN K153296 | HRX Priscilla Chung [IMEDICOM Co., Ltd.]	B-Two Vertebral Balloon Expand? Kyphoplasty System	2016-09-06
PMN K153296 | HRX Priscilla Chung [IMEDICOM Co., Ltd.]	B-Two Inflatable bone expander system syringe	2016-09-06
PMN K153296 | HRX Priscilla Chung [IMEDICOM Co., Ltd.]	B-Two Inflatable bone expander system baloon catheter	2016-09-06
PMN K153296 IMEDICOM Co., Ltd.	MEDINAUT Kyphoplasty System	2016-07-29
PMN K150915 IMEDICOM CO., LTD.	SPINAUT-P	2016-03-18
PMN K151268 IMEDICOM CO., LTD.	SPINAUT-V, SPINAUT-S, SPINAUT-I	2016-03-16
PMN K150789 IMEDICOM CO., LTD.	SPINAUT-E, SPINAUT-I	2016-03-01
JDZ Priscilla Chung [IMEDICOM Co., Ltd.]	MCX Plus (various models)	2015-11-20
JDZ Priscilla Chung [IMEDICOM Co., Ltd.]	MCX Light (various models)	2015-11-20
JDZ Priscilla Chung [IMEDICOM Co., Ltd.]	MCX (various models)	2015-11-20
LXH Priscilla Chung [IMEDICOM Co., Ltd.]	SPINAUT-Ix(various models)	2015-10-05
LXH Priscilla Chung [IMEDICOM Co., Ltd.]	MEDINAUT-Ix(various models)	2015-10-05
OAR Priscilla Chung [IMEDICOM Co., Ltd.]	MEDINAUT-V	2015-01-22
PMN K133669 | NDN Priscilla Chung [IMEDICOM Co., Ltd.]	MEDINAUT-X	2014-04-09
PMN K133669 | NDN Priscilla Chung [IMEDICOM Co., Ltd.]	MEDINAUT-Ix	2014-04-09
PMN K133669 | NDN Priscilla Chung [IMEDICOM Co., Ltd.]	MEDINAUT-I	2014-04-09
PMN K133669 | NDN Priscilla Chung [IMEDICOM Co., Ltd.]	MEDINAUT Kyphoplasty System	2014-04-09
PMN K133669 | NDN Priscilla Chung [IMEDICOM Co., Ltd.]	B-Two Vertebral access system	2014-04-09
PMN K133669 | NDN Priscilla Chung [IMEDICOM Co., Ltd.]	B-Two Vertebral Balloon Expand? Kyphoplasty System	2014-04-09
PMN K133669 | NDN Priscilla Chung [IMEDICOM Co., Ltd.]	B-Two Inflatable bone expander system syringe	2014-04-09
PMN K133669 | NDN Priscilla Chung [IMEDICOM Co., Ltd.]	B-Two Inflatable bone expander system balloon catheter	2014-04-09
PMN K133669 | HRX Priscilla Chung [IMEDICOM Co., Ltd.]	MEDINAUT-X	2014-04-09
PMN K133669 | HRX Priscilla Chung [IMEDICOM Co., Ltd.]	MEDINAUT-Ix	2014-04-09
PMN K133669 | HRX Priscilla Chung [IMEDICOM Co., Ltd.]	MEDINAUT-I	2014-04-09
PMN K133669 | HRX Priscilla Chung [IMEDICOM Co., Ltd.]	MEDINAUT Kyphoplasty System	2014-04-09
PMN K133669 | HRX Priscilla Chung [IMEDICOM Co., Ltd.]	B-Two Vertebral access system	2014-04-09
PMN K133669 | HRX Priscilla Chung [IMEDICOM Co., Ltd.]	B-Two Vertebral Balloon Expand? Kyphoplasty System	2014-04-09
PMN K133669 | HRX Priscilla Chung [IMEDICOM Co., Ltd.]	B-Two Inflatable bone expander system syringe	2014-04-09
PMN K133669 | HRX Priscilla Chung [IMEDICOM Co., Ltd.]	B-Two Inflatable bone expander system balloon catheter	2014-04-09
GEY Priscilla Chung [IMEDICOM Co., Ltd.]	ZAGUAR	2014-03-24
HTT Priscilla Chung [IMEDICOM Co., Ltd.]	IMEDICOM HIGH SPEED BLADE	2012-07-04
GFA Priscilla Chung [IMEDICOM Co., Ltd.]	IMEDICOM SAW BLADE	2012-07-04
GET Priscilla Chung [IMEDICOM Co., Ltd.]	LEOPARD (various models)	2012-07-04