2,618 results · 38ms · Sources: EU EUDAMED, US FDA

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval
FDA Class 3 ·FoundationOne Liquid CDx (F1LCDx)

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval
FDA Class 3 ·FoundationOne®Liquid CDx

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval
FDA Class 3 ·FoundationOne Liquid CDx (F1LCDx)

Applied Biosystems™ QuantStudio™ 5 Dx Real-Time PCR System

FDA UDI
LIFE TECHNOLOGIES HOLDINGS PTE. LTD.·10190302015592·

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·LeukoStrat CDx FLT3 Mutation Assay

JedX 3972 W FT HL

Basic UDI-DI
EU MDR · Eu Md Class 1 ·JedX Medcare·1 device

JedX 3971 W FT HL

Basic UDI-DI
EU MDR · Eu Md Class 1 ·JedX Medcare·1 device

JedX Medcare FFP2 NR

Basic UDI-DI
EU MDR · Eu Md Class 1 ·JedX Medcare·1 device

JedX 3614 W FT HLVP

Basic UDI-DI
EU MDR · Eu Md Class 1 ·JedX Medcare·1 device

JedX 3805 W FT HLPV

Basic UDI-DI
EU MDR · Eu Md Class 1 ·JedX Medcare·1 device

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·IDENTITY/IDENTITY ADX, INFINITY AND INTEGRITY FAMILIES OF PACEMAKERS

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval
FDA Class 3 ·RHYTHMIA HDx™ Ablation Connection Box (for INTELLAGEN™); Rhythmia HDx™ Ablation Connection Box (Maestro™)

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·IDENTITY/IDENTITY ADX, INTEGRITY, AFFINITY, AND ENTITY PULSE GENERATOR MODELS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity XL, Identity ADx XL, Verity ADx XL

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity XL, Identity ADx XL, Verity ADx XL

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity XL, Identity ADx XL, Verity ADx XL

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·VICTORY, ZEPHYR, ACCENT, ASSURITY, ASSURITY+, ENDURITY, IDENTITY ADX, VERITY ADX FAMILY OF PACEMAKER DEVICES

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·VICTORY, ZEPHYR, ACCENT, ASSURITY, ASSURITY+, ENDURITY, IDENTITY ADX, VERITY ADX FAMILY OF PACEMAKER DEVICES

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·VICTORY, ZEPHYR, ACCENT, ASSURITY, ASSURITY+, ENDURITY, IDENTITY ADX, VERITY ADX FAMILY OF PACEMAKERS DEVICES

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·LeukoStrat CDx FLT3 Mutation Assay