10,000 results · 182ms · Sources: EU EUDAMED, US FDA

CryoOne

FDA registration
ENRAF-NONIUS B.V.·1 product·🇳🇱 Netherlands

Sonopuls 494

FDA registration
ENRAF-NONIUS B.V.·1 product·🇳🇱 Netherlands

Curapuls 670

FDA registration
ENRAF-NONIUS B.V.·1 product·🇳🇱 Netherlands

Omniversa

FDA registration
ENRAF-NONIUS B.V.·3 products·🇳🇱 Netherlands

ManuMax

FDA registration
ENRAF-NONIUS B.V.·1 product·🇳🇱 Netherlands

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·CAPSUREFIX LEAD; CAPSUREFIX NOVUS LEAD; SUREFIX LEAD;VITATRON CRYSTALLINE ACTIVE FIXATION LEAD; VITATRON CRYSTALLINE ACT

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·CAPSUREFIX LEAD, CAPSUREFIX NOVUS LEAD,SUREFIX LEAD, VITATRON CRYSTALLINE ACTIVE FIXATION LEAD, VITATRON CRYSTALLINE ACT

GOWNS

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Cam Hospital srl·4 devices

CUSTOM PACK CHIRURGIA COLONNA

Basic UDI-DI
EU MDR · Eu Md Class 2a ·Cam Hospital srl·2 devices

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·Blazer II Cardiac Ablation System

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval
FDA Class 3 ·Rotablator Rotational Angioplasty System Guidewire

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·Chilli II Cooled RF Ablation system

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

FDA Pre-Market Approval
FDA Class 3 ·Blazer II XP Cardiac RF Ablation System

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

FDA Pre-Market Approval
FDA Class 3 ·Blazer Open Irrigated Cardiac Ablation System

Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

FDA Pre-Market Approval
FDA Class 3 ·Wolverine Coronary Cutting Balloon (Monorail and Over-The-Wire)

Stent, Renal

FDA Pre-Market Approval
FDA Class 3 ·Express SD Monorail Premounted Stent System

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·Rebel Platinum Chromium Coronary Stent System (Monorail and Over-the-Wire)

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·Promus Premier Everolimus-Eluting Platinum Chromium Coronary Stent System

Perifit

FDA registration
X6 INNOVATIONS·1 product·🇫🇷 France

Perifit Pump

FDA registration
X6 INNOVATIONS·1 product·🇫🇷 France