Sfm Medical Devices G M B H

FDA Filings

This page includes the latest FDA filings for Sfm Medical Devices G M B H. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3015546986
• FEI Number: 3015546986
• Name: sfm medical devices USA, Inc.
• Owner & Operator: sfm medical devices GmbH
• Contact Address: Brueckenstrasse 5 --; Waechtersbach DE-NOTA 63607 DE
• Official Correspondent:
  • Olaf Broemsen
  • 49-605-3805224-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 15170 Chippendale Ave. Suite 103 ; Rosemount, MN 55068 US

• Registration Number: 1000632857
• FEI Number: 1000632857
• Name: Phil Triolo
• Owner & Operator: sfm medical devices GmbH
• Contact Address: Brueckenstrasse 5 --; Waechtersbach DE-NOTA 63607 DE
• Official Correspondent:
  • Olaf Broemsen
  • 49-605-3805224-x
• US Agent:
  • Phil Triolo
  • Phil Triolo and Associates LC
  • 801 6999846
  • 801 3282399
  • philt@philt.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 86 Skycrest Ln ; Salt Lake City, UT 84108 US
• Establishment Type:
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Manufacture Medical Device

• Registration Number: 3007221462
• FEI Number: 3007221462
• Name: Phil Triolo
• Owner & Operator: sfm medical devices GmbH
• Contact Address: Brueckenstrasse 5 --; Waechtersbach DE-NOTA 63607 DE
• Official Correspondent:
  • Olaf Broemsen
  • 49-605-3805224-x
• US Agent:
  • Phil Triolo
  • Phil Triolo and Associates LC
  • 801 6999846
  • 801 3282399
  • philt@philt.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 86 Skycrest Ln ; Salt Lake City, UT 84108 US
• Establishment Type: Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
GUDID 04063574200401 sfm medical devices GmbH	nextaro® v, 20/20, 5 µm	2024-09-19
GUDID 04063574200371 sfm medical devices GmbH	nextaro® va, 15mm, 5µm	2024-09-19
GUDID 04063574200357 sfm medical devices GmbH	nextaro® v, 20/32, 15 µm nominal	2024-06-13
GUDID 04063574200272 sfm medical devices GmbH	nextaro® v, 20/20, 15 µm nominal	2024-05-02
GUDID 04063574200296 sfm medical devices GmbH	nextaro® va	2023-08-25
GUDID 04063574200012 sfm medical devices GmbH	nextaro®	2022-04-04
GUDID 04063574848801 sfm medical devices GmbH	Filter 20µm	2021-10-04
GUDID 04063574100022 sfm medical devices GmbH	nextaro® va	2021-10-01
GUDID 04063574100015 sfm medical devices GmbH	nextaro®	2021-10-01
GUDID 04063574100008 sfm medical devices GmbH	Cannula for subcutaneous Implant/ pellet administration	2021-10-01
PMN K183187 SFM Medical Devices GmbH	Nextaro Transfer System, Nextaro Va	2019-03-15
HTW Phil Triolo [sfm medical devices GmbH]	Access Drill, 10G, sterile	2017-05-22
GEA Phil Triolo [sfm medical devices GmbH]	Implanter cannula	2017-05-22
GEA Phil Triolo [sfm medical devices GmbH]	Cannula for subcutaneous implant/pellet administration	2017-05-22
GEA Phil Triolo [sfm medical devices GmbH]	AccessKit, 10G, Single Pack, Diamond, Side Opening, sterile	2017-05-22
GEA Phil Triolo [sfm medical devices GmbH]	AccessKit, 10G, Single Pack, Diamond, End Opening, sterile	2017-05-22
GEA Phil Triolo [sfm medical devices GmbH]	AccessKit, 10G, Single Pack, Bevel, Side Opening, sterile	2017-05-22
GEA Phil Triolo [sfm medical devices GmbH]	AccessKit, 10G, Single Pack, Bevel, End Opening, sterile	2017-05-22
MJG Phil Triolo [sfm medical devices GmbH]	Biopsy Kit, 10G, sterile	2007-07-23