2,427 results · 41ms · Sources: EU EUDAMED, US FDA

KSEA Monopolar Resectoscopes

FDA registration
KARL STORZ SE & CO KG·5 products·🇩🇪 Germany

Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation

FDA Pre-Market Approval
FDA Class 3 ·Organ Care System (OCS®) Liver™

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

FDA Pre-Market Approval
FDA Class 3 ·FoundationOne CDx (F1CDx)

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

FDA Pre-Market Approval
FDA Class 3 ·FoundationOne Liquid CDx (F1 Liquid CDx)

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·HIRESOLUTION BIONIC EAR SYSTEM

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·ACS MULTI-LINK CORONARY STENT SYSTEMS

Processor, Cervical Cytology Slide, Automated

FDA Pre-Market Approval
FDA Class 3 ·THINPREP 2000 SYSTEM

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval
FDA Class 2 ·HEALTHTRONICS LITHOTRON LIHTOTRIPSY SYSTEM

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

FDA Pre-Market Approval
FDA Class 3 ·BLAZER OPEN-IRRIGATED ABLATION CATHETER

Heat and moisture exchange filters

Basic UDI-DI
EU MDR · Eu Md Class 2a ·Ningbo Shengyurui Medical Appliances Co., Ltd.·2 devices

Disinfecting Cap

Basic UDI-DI
EU MDD · Eu Md Class 2a ·ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETI·1 device

Anesthesia Mask

Basic UDI-DI
EU MDR · Eu Md Class 2a ·Ningbo Shengyurui Medical Appliances Co., Ltd.·15 devices

1.5T and 3T 6 Channel Phased Array Flex Coil

Basic UDI-DI
EU MDR · Eu Md Class 1 ·GE Medical Systems LLC·2 devices

5” Round Coil 1.5T

Basic UDI-DI
EU MDR · Eu Md Class 1 ·GE Medical Systems LLC·1 device

1.5T GP Flex Coil

Basic UDI-DI
EU MDR · Eu Md Class 1 ·GE Medical Systems LLC·1 device

3” Round Coil 1.5T

Basic UDI-DI
EU MDR · Eu Md Class 1 ·GE Medical Systems LLC·1 device

Attention assessment software

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Boke Medical Technology (Shanghai) Co., Ltd·1 device

nasal cannula

Basic UDI-DI
EU MDR · Eu Md Class 2a ·Ningbo Shengyurui Medical Appliances Co., Ltd.·108 devices

Pulsenmore ES

Basic UDI-DI
EU MDD · Eu Md Class 2a ·Pulsenmore Ltd·1 device

Pulsenmore ES

Basic UDI-DI
EU MDD · Eu Md Class 2a ·Pulsenmore Ltd·1 device