This page includes the latest FDA filings for Orbusneich Medical Co L T D A Co Inc I. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 3003775186 |
| FEI Number | 3003775186 |
| Name | John Pazienza |
| Owner & Operator | OrbusNeich Medical Company Limited (a company incorporated i |
| Contact Address | Unit 303 & 305, 3F, Building 20E Hong Kong Science Park Sha Tin, N.T. HK-NA -- HK |
| US Agent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 5363 NW 35th Ave Fort Lauderdale, FL 33309 US |
| Establishment Type | Manufacture Medical Device |
| Registration Number | 1064498 |
| FEI Number | 3002394096 |
| Name | ORBUSNEICH MEDICAL, INC. |
| Owner & Operator | OrbusNeich Medical Company Limited (a company incorporated i |
| Contact Address | Unit 303 & 305, 3F, Building 20E Hong Kong Science Park Sha Tin, N.T. HK-NA -- HK |
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 5363 NW 35th Ave Fort Lauderdale, FL 33309 US |
| Establishment Type | Complaint File Establishment per 21 CFR 820.198 |
Device Company | Device | Date |
|---|---|---|
John Pazienza [OrbusNeich Medical Company Limited (a company incorporated i] | Teleport Microcatheter | 2019-03-18 |
John Pazienza [OrbusNeich Medical Company Limited (a company incorporated i] | Jade PTA | 2018-03-02 |
John Pazienza [OrbusNeich Medical Company Limited (a company incorporated i] | Sapphire II Pro | 2018-03-02 |
ORBUSNEICH MEDICAL, INC. [OrbusNeich Medical Company Limited (a company incorporated i] | Sapphire II Pro Coronary Dilatation Catheter | 2017-08-08 |
John Pazienza [OrbusNeich Medical Company Limited (a company incorporated i] | Sapphire II Pro Coronary Dilatation Catheter | 2017-08-08 |
ORBUSNEICH MEDICAL, INC. [OrbusNeich Medical Company Limited (a company incorporated i] | Sapphire NC Plus Coronary Dilatation Catheter | 2017-08-08 |
John Pazienza [OrbusNeich Medical Company Limited (a company incorporated i] | Sapphire NC Plus Coronary Dilatation Catheter | 2017-08-08 |
ORBUSNEICH MEDICAL, INC. [OrbusNeich Medical Company Limited (a company incorporated i] | Sapphire NC PTCA | 2011-09-08 |
John Pazienza [OrbusNeich Medical Company Limited (a company incorporated i] | Sapphire NC PTCA | 2011-09-08 |
ORBUSNEICH MEDICAL, INC. [OrbusNeich Medical Company Limited (a company incorporated i] | Sapphire PTCA | 2011-09-08 |
John Pazienza [OrbusNeich Medical Company Limited (a company incorporated i] | Sapphire PTCA | 2011-09-08 |