7,545 results · 39ms · Sources: EU EUDAMED, US FDA

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·SENSOLOG/DIALOG/REGENCY FAMILT OF PACEMAKERS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·PROMOTE CRT-D; CADENCE FAMILY OF ICDS

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

FDA Pre-Market Approval
FDA Class 3 ·CURRENT ICD; EPIC HF/ ATLAS + HF FAMILY OF CRT-DS

Pulse-Generator, Single Chamber, Sensor Driven, Implantable

FDA Pre-Market Approval
FDA Class 3 ·MICRONY FAMILY OF PACEMAKERS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·PARAGON/PHOENIX FAMILY OF PACEMAKERS

Geo LB Cylinder Abutment

Basic UDI-DI
EU MDD · Eu Md Class 2b ·GeoMedi Co., Ltd.·1 device

SureStep Big Shot AFO

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Surestep, LLC·1 device

OHI International Limited

Authorized representative
4 Manufacturers

Maramed Posterior Leaf Spring AFO

Basic UDI-DI
EU MDR · Eu Md Class 1 ·BioSculptor Corporation·2 devices

SureStep Big Shot AFO Lite

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Surestep, LLC·1 device

Geo-Trade 2000 Kft.

Importer
🇭🇺 Hungary

GKO ECOBLAST SERVICES SRL

Importer
🇷🇴 Romania

Jade PTA Balloon Dilatation Catheter

FDA registration
OrbusNeich Medical (Shenzhen) Co., Ltd.·1 product·🇨🇳 China

JADE PTA Balloon Dilatation Catheter

FDA registration
OrbusNeich Medical (Shenzhen) Co., Ltd.·1 product·🇨🇳 China

Teleport Microcatheter

FDA registration
OrbusNeich Medical (Shenzhen) Co., Ltd.·1 product·🇨🇳 China

Sapphire II Pro Coronary Dilatation Catheter

FDA registration
OrbusNeich Medical (Shenzhen) Co., Ltd.·2 products·🇨🇳 China

Teleport XT Microcatheter

FDA registration
OrbusNeich Medical (Shenzhen) Co., Ltd.·1 product·🇨🇳 China

Sapphire NC 24 Coronary Dilatation Catheter

FDA registration
OrbusNeich Medical (Shenzhen) Co., Ltd.·1 product·🇨🇳 China

Scoreflex NC Scoring PTCA Catheter

FDA registration
OrbusNeich Medical (Shenzhen) Co., Ltd.·1 product·🇨🇳 China