5,798 results · 41ms · Sources: EU EUDAMED, US FDA

Sentosa SQ HIV-1 Genotyping Assay; Sentosa SQ HIV-1 Positive Control Kit

FDA registration
VELA DIAGNOSTICS USA, INC·1 product·🇺🇸 United States

Sentosa SQ HIV-1 Genotyping Assay

FDA registration
VELA DIAGNOSTICS USA, INC·1 product·🇺🇸 United States

Sentosa SQ HIV-1 Positive Control Kit

FDA registration
Vela Operations Singapore Pte Ltd·1 product·🇸🇬 Singapore

Sentosa SQ HIV-1 Genotyping Assay

FDA registration
Vela Operations Singapore Pte Ltd·1 product·🇸🇬 Singapore

Intravascular Radiation Delivery System

FDA Pre-Market Approval
FDA Class 3 ·Novoste™ Beta-Cath™ System

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·NG3 Implantable Cardiac Defibrillators, Autogen, Dynagen, Inogen, Origen ICD's; NG4 ICDs- Momentum, Vigilant, Perciva,Re

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·NG3 Implantable Cardiac Defibrillators, Autogen, Dynagen, Inogen, Origen ICD's; NG4 ICDs- Momentum, Vigilant, Perciva,Re

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Autogen, Dynagen, Inogen, and Origen NG3 ICDs and Resonate, Momentum, Vigilant, and Perciva NG4 ICDs

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval
FDA Class 3 ·Autogen, Dynagen, Inogen, Origen - NG3 Cardiac Resynchronization Therapy / Momentum, Vigilant, Resonate - NG4 CRT-D Devi

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·NG3 Implantable Cardiac Defibrillators (ICDs): AUTOGEN, DYNAGEN, INOGEN and ORIGEN; NG4 ICDs: MOMENTUM, VIGILANT, PERCIV

BGI

Device
EU IVDR · Eu Ivd Class A ·BGI EUROPE A/S·On the market

BGI

Device
EU IVDR · Eu Ivd Class A ·BGI EUROPE A/S·On the market

BGI

Device
EU IVDR · Eu Ivd Class A ·BGI EUROPE A/S·On the market

BGI

Device
EU IVDR · Eu Ivd Class A ·BGI EUROPE A/S·On the market

BGI

Device
EU IVDR · Eu Ivd Class A ·BGI EUROPE A/S·On the market

BGI

Device
EU IVDR · Eu Ivd Class A ·BGI EUROPE A/S·On the market

BGI

Device
EU IVDR · Eu Ivd Class A ·BGI EUROPE A/S·On the market

BGI

Device
EU IVDR · Eu Ivd Class A ·BGI EUROPE A/S·On the market

BGI

Device
EU IVDR · Eu Ivd Class A ·BGI EUROPE A/S·On the market

BGI

Device
EU IVDR · Eu Ivd Class A ·BGI EUROPE A/S·On the market