Vistamed L T D

FDA Filings

This page includes the latest FDA filings for Vistamed 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: 3008328690
• FEI Number: 3008328690
• Name: VISTAMED LTD
• Owner & Operator: VistaMed Ltd
• Contact Address: IDA Business and Technology Park ; Carrick-on-Shannon IE-LM Leitrim 0000 IE
• Official Correspondent:
  • Declan Whyte
  • 353-71-9638833-x
• US Agent:
  • Belinda Jackon
  • Freudenberg Medical
  • 805 5765308
  • belinda.jackson@freudenbergmedical.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: IDA Business and Technology Park ; Carrick-on-Shannon Leitrim, 0000 IE
• Establishment Type: Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
PMN K123942 | NDN VISTAMED LTD	iVAS Inflatable Vertebral Augmentation System 15mm (10G)	2017-07-21
PMN K123942 | NDN VISTAMED LTD	iVAS Inflatable Vertebral Augmentation System 10.0mm 10G	2017-07-21
PMN K123942 | NDN VISTAMED LTD	iVAS 10G 20mm Inflatable Vertebral Augmentation System	2017-07-21
PMN K123942 | NDN VISTAMED LTD	IVAS Balloon Catheter 20.0mm (10G)	2017-07-21
PMN K123942 | NDN VISTAMED LTD	IVAS Balloon Catheter 15.0mm (10G)	2017-07-21
PMN K123942 | NDN VISTAMED LTD	IVAS Balloon Catheter 10.0mm (10G)	2017-07-21
PMN K123942 | HRX VISTAMED LTD	iVAS Inflatable Vertebral Augmentation System 15mm (10G)	2017-07-21
PMN K123942 | HRX VISTAMED LTD	iVAS Inflatable Vertebral Augmentation System 10.0mm 10G	2017-07-21
PMN K123942 | HRX VISTAMED LTD	iVAS 10G 20mm Inflatable Vertebral Augmentation System	2017-07-21
PMN K123942 | HRX VISTAMED LTD	IVAS Balloon Catheter 20.0mm (10G)	2017-07-21
PMN K123942 | HRX VISTAMED LTD	IVAS Balloon Catheter 15.0mm (10G)	2017-07-21
PMN K123942 | HRX VISTAMED LTD	IVAS Balloon Catheter 10.0mm (10G)	2017-07-21
PMN K151243 | FCS VISTAMED LTD	Infravision Universal Ureteral Kit	2016-08-16
PMN K151243 | FCS VISTAMED LTD	IRIS Uretal Kit	2016-08-16
PMN K031617 | KLA VISTAMED LTD	Single use Lower GI Manometry Catheter	2014-12-09
PMN K013704 | KLA VISTAMED LTD	Single Use GI Manometry Catheter	2014-12-09
PMN K130430 | NDN VISTAMED LTD	iVAS Inflatable Vertebral Augmentation System 15.0mm, (11G)	2014-08-21
PMN K130430 | NDN VISTAMED LTD	iVAS Inflatable Vertebral Augmentation System 10.0mm, (11G)	2014-08-21
PMN K130430 | NDN VISTAMED LTD	iVAS Balloon Catheter 15mm (11G)	2014-08-21
PMN K130430 | NDN VISTAMED LTD	iVAS Balloon Catheter 10mm (11G)	2014-08-21
PMN K130430 | HRX VISTAMED LTD	iVAS Inflatable Vertebral Augmentation System 15.0mm, (11G)	2014-08-21
PMN K130430 | HRX VISTAMED LTD	iVAS Inflatable Vertebral Augmentation System 10.0mm, (11G)	2014-08-21
PMN K130430 | HRX VISTAMED LTD	iVAS Balloon Catheter 15mm (11G)	2014-08-21
PMN K130430 | HRX VISTAMED LTD	iVAS Balloon Catheter 10mm (11G)	2014-08-21
PMN K093419 | NDN VISTAMED LTD	iVAS Inflatable Vertebral Augmentation System 15.00mm (8G)	2010-03-22
PMN K093419 | NDN VISTAMED LTD	iVAS Inflatable Vertebral Augmentation System 10mm (8G)	2010-03-22
PMN K093419 | NDN VISTAMED LTD	iVAS 8G 20mm Inflatable Vertebral Augmentation System	2010-03-22
PMN K093419 | HRX VISTAMED LTD	iVAS Inflatable Vertebral Augmentation System 15.00mm (8G)	2010-03-22
PMN K093419 | HRX VISTAMED LTD	iVAS Inflatable Vertebral Augmentation System 10mm (8G)	2010-03-22
PMN K093419 | HRX VISTAMED LTD	iVAS 8G 20mm Inflatable Vertebral Augmentation System	2010-03-22