Medionics I N T Inc

FDA Filings

This page includes the latest FDA filings for Medionics I N T Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number9611088
FEI Number3002807599
NameMichael van der Woude
Owner & OperatorMEDIONICS INTERNATIONAL, INC.
Contact Address114 ANDERSON AVE.
MARKHAM CA-ON Ontario L6E 1A5 CA
Official Correspondent
  • MAHESH C AGARWAL
  • 1-905-4726544-x
US Agent
Importing Logistics Registration
Importer6624C Renal Care Center
Address2220 Moorpark Avenue
San Jose, CA 95128 UNITED STATES
Importer TypeEnd User
Importing Logistics Registration
ImporterCleveland Clinic
Address1950 Richmond Road
Cleveland, OH 44124 UNITED STATES
Importer TypeEnd User
Importing Logistics Registration
ImporterMedical University of South Carolina
Address165 Ashley Avenue
Charleston, SC 29425 UNITED STATES
Importer TypeEnd User
Importing Logistics Registration
ImporterSanta Clara Valley Health & Hospital System
Address751 South Bascom Avenue
San Jose, CA 95128 UNITED STATES
Importer TypeEnd User
Importing Logistics Registration
ImporterSkagit Valley Hospital
Address1415 E Kincaid
Mount Vernon, WA 98274 UNITED STATES
Importer TypeEnd User
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2500 Bee Cave Road Bldg 1, Suite 300
Austin, TX 78746 US
Establishment TypeManufacture Medical Device

FDA Filings

Device
Company
DeviceDate
Medionics International Inc
 Peritoneal Dialysis Catheter SA-12552018-07-06
Medionics International Inc
 Peritoneal Dialysis Catheter PSNA-1002018-07-06
Medionics International Inc
 Faller Stylet FS-4032018-07-06
Medionics International Inc
 Faller Stylet FS-4022018-07-06
Medionics International Inc
 Peritoneal Dialysis Catheter SNCA-5263LFD2018-07-06
Medionics International Inc
 Peritoneal Dialysis Catheter SNPS-531132018-07-06
Medionics International Inc
 Faller Stylet FS-4012018-07-06
Medionics International Inc
 Peritoneal Dialysis Catheter Adapter TA-3002018-07-06
Medionics International Inc
 Peritoneal Dialysis Catheter Adapter TA-2002018-07-06
Medionics International Inc
 Peritoneal Dialysis Catheter SNCP-5243L2018-07-06
Medionics International Inc
 Peritoneal Dialysis Catheter SNCA-5262L2018-07-06
Medionics International Inc
 Peritoneal Dialysis Catheter CP-12412018-07-06
Medionics International Inc
 Peritoneal Dialysis Catheter CA-11572018-07-06
Medionics International Inc
 Peritoneal Dialysis Catheter CA-11622018-07-06
Medionics International Inc
 Peritoneal Dialysis Catheter CA-22622018-07-06
Medionics International Inc
 Peritoneal Dialysis Catheter SI-12312018-07-06
Medionics International Inc
 Peritoneal Dialysis Catheter SA-1248K2018-07-06
Medionics International Inc
 Peritoneal Dialysis Catheter SA-12472018-07-06
Medionics International Inc
 Stylet SST-6502018-05-10
Michael van der Woude [MEDIONICS INTERNATIONAL, INC.]
Stylet #SST-6502013-06-04
Michael van der Woude [MEDIONICS INTERNATIONAL, INC.]
Faller Stylet #FS-4032013-05-10
Michael van der Woude [MEDIONICS INTERNATIONAL, INC.]
Faller Stylet #FS-4022013-05-10
Michael van der Woude [MEDIONICS INTERNATIONAL, INC.]
Faller Stylet #FS-4012013-05-10
MEDIONICS INTERNATIONAL, INC.
FALLER STYLET2013-04-19
Michael van der Woude [MEDIONICS INTERNATIONAL, INC.]
Peritoneal Dialysis Catheter Adapter #TA-3002007-12-05
Michael van der Woude [MEDIONICS INTERNATIONAL, INC.]
Peritoneal Dialysis Catheter Adapter #TA-2002007-12-05
Michael van der Woude [MEDIONICS INTERNATIONAL, INC.]
Peritoneal Dialysis Catheter #SNPS-531132007-12-05
Michael van der Woude [MEDIONICS INTERNATIONAL, INC.]
Peritoneal Dialysis Catheter #SNCP-5243L2007-12-05
Michael van der Woude [MEDIONICS INTERNATIONAL, INC.]
Peritoneal Dialysis Catheter #SNCA-5263LFD2007-12-05
Michael van der Woude [MEDIONICS INTERNATIONAL, INC.]
Peritoneal Dialysis Catheter #SNCA-5262L2007-12-05
Michael van der Woude [MEDIONICS INTERNATIONAL, INC.]
Peritoneal Dialysis Catheter #SI-12312007-12-05
Michael van der Woude [MEDIONICS INTERNATIONAL, INC.]
Peritoneal Dialysis Catheter #SA-12552007-12-05
Michael van der Woude [MEDIONICS INTERNATIONAL, INC.]
Peritoneal Dialysis Catheter #SA-1248K2007-12-05
Michael van der Woude [MEDIONICS INTERNATIONAL, INC.]
Peritoneal Dialysis Catheter #SA-12472007-12-05
Michael van der Woude [MEDIONICS INTERNATIONAL, INC.]
Peritoneal Dialysis Catheter #PSNA-1002007-12-05
Michael van der Woude [MEDIONICS INTERNATIONAL, INC.]
Peritoneal Dialysis Catheter #CP-12412007-12-05
Michael van der Woude [MEDIONICS INTERNATIONAL, INC.]
Peritoneal Dialysis Catheter #CA-22622007-12-05
Michael van der Woude [MEDIONICS INTERNATIONAL, INC.]
Peritoneal Dialysis Catheter #CA-11622007-12-05
Michael van der Woude [MEDIONICS INTERNATIONAL, INC.]
Peritoneal Dialysis Catheter #CA-11572007-12-05
MEDIONICS INTERNATIONAL, INC.
PERITONEAL DIALYSIS CATHETERS AND ADAPTERS2000-04-28
MEDIONICS INTERNATIONAL, INC.
EASY CARE AND TUBING SETS2000-02-10
MEDIONICS INTERNATIONAL, INC.
QC CAP1995-02-07

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020070455887Vancouver, BC ,Canada -> Seattle, WashingtonDIALYSIS TUBING SHIPPER'S LOAD, STOW, WEIGHT, COUNT & SEAL FREIGHT PREPAID PRN# 01F219BC74 7520200600024 HS CODE: 9018908 SKD
2020070268324Vancouver, BC ,Canada -> Seattle, WashingtonDIALYSIS TUBING SHIPPER'S LOAD, STOW, WEIGHT, COUNT & SEAL FREIGHT PREPAID PRN# 01F219BC74 7520200600024 HS CODE: 9018908 SKD
2019101155425Vancouver, BC ,Canada -> Seattle, WashingtonOF DIALYSIS TUBING & ACCESSORIES HS CODE: 901 890 FREIGHT PREPAID CAED# 01F219BC7475201909 00039 SHIPPER'S LOAD, STOW, WEIGHT, COUNT & SEAL8 SKD
2019101066754Vancouver, BC ,Canada -> Seattle, WashingtonOF DIALYSIS TUBING & ACCESSORIES HS CODE: 901 890 FREIGHT PREPAID CAED# 01F219BC7475201909 00039 SHIPPER'S LOAD, STOW, WEIGHT, COUNT & SEAL8 SKD
2019010146258Vancouver, BC ,Canada -> Seattle, WashingtonEASY CARE TUBING SET OF EASY CARE TUBING SET EC-3A5BY CAED01F219BC74752018120006114 PCS
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