Orbusneich Medical Trading Inc

FDA Filings

This page includes the latest FDA filings for Orbusneich Medical Trading Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Orbusneich Medical Trading Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• John Pazienza

FDA Registration(s)

• Registration Number: 3014148220
• FEI Number: 3014148220
• Name: ORBUSNEICH MEDICAL TRADING, INC.
• Owner & Operator: OrbusNeich Medical Trading, Inc.
• Contact Address: 5363 NW 35th Avenue ; Fort Lauderdale FL 33309 US
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 5363 NW 35th Avenue ; Fort Lauderdale, FL 33309 US
• Establishment Type: Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
PMN K200269 OrbusNeich Medical Trading Inc.	Sapphire II PRO	2020-03-04
PMN K192344 | LOX ORBUSNEICH MEDICAL TRADING, INC.	Sapphire NC Plus	2019-10-23
PMN K192344 OrbusNeich Medical Trading Inc.	Sapphire NC Plus Coronary Dilatation Catheter	2019-09-19
PMN K182713 | PNO ORBUSNEICH MEDICAL TRADING, INC.	Scoreflex PTA Scoring Balloon Catheter	2019-06-18
PMN K182713 | LIT ORBUSNEICH MEDICAL TRADING, INC.	Scoreflex PTA Scoring Balloon Catheter	2019-06-18
PMN K182713 OrbusNeich Medical Trading, Inc.	Scoreflex PTA Scoring Balloon Catheter	2019-06-11
PMN K182360 | DQY ORBUSNEICH MEDICAL TRADING, INC.	Teleport Microcatheter	2018-11-12
PMN K182360 OrbusNeich Medical Trading Inc.	Teleport Microcatheter	2018-11-09
PMN K180921 | LOX ORBUSNEICH MEDICAL TRADING, INC.	Sapphire II PRO	2018-08-30
PMN K180921 | LIT ORBUSNEICH MEDICAL TRADING, INC.	Sapphire II PRO	2018-08-30
PMN K180921 OrbusNeich Medical Trading Inc.	Sapphire II PRO Balloon Dilatation Catheter	2018-06-28
PMN K173680 | LOX ORBUSNEICH MEDICAL TRADING, INC.	Sapphire II Pro	2018-03-02
PMN K173680 OrbusNeich Medical Trading Inc.	Sapphire II PRO	2018-03-01
PMN K173894 | LIT ORBUSNEICH MEDICAL TRADING, INC.	Jade PTA	2018-02-23
PMN K173894 OrbusNeich Medical Trading Inc.	Jade PTA Balloon Dilatation Catheter	2018-02-09
PMN K163114 | LOX ORBUSNEICH MEDICAL TRADING, INC.	Sapphire II PRO	2017-12-18
PMN K162209 | LOX ORBUSNEICH MEDICAL TRADING, INC.	Sapphire NC Plus	2017-12-18
PMN K103808 | LOX ORBUSNEICH MEDICAL TRADING, INC.	Sapphire NC	2017-12-18
PMN K103657 | LOX ORBUSNEICH MEDICAL TRADING, INC.	Sapphire	2017-12-18