38 results · 21ms · Sources: EU EUDAMED, US FDA

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Brand Name: NIO+ Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000908 Software Version: N/A Product Description: NIO devices are a spring-based, automatic intraosseous access device supplied Sterile and single use. Indicated for Intraosseous access to the Proximal humerus and Proximal Tibia in adult patients, in emergent situations. Component: N/A

FDA Enforcement
Class II ·Ongoing·Waismed Ltd.·July 23, 2025

Brand Name: NIO-A Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000603 Software Version: N/A Product Description: NIO devices are a spring-based, automatic intra-osseous access device supplied Sterile and single use. Indicated for Intra-osseous access to the Proximal humerus and Proximal Tibia in adult patients, in emergent situations. Component: N/A

FDA Enforcement
Class II ·Ongoing·Waismed Ltd.·July 23, 2025

Accurate Medical Therapeutics Ltd.

Manufacturer
🇮🇱 Israel·1 Importer

GE Medical Systems Israel", Functional Imaging

Manufacturer
🇮🇱 Israel·6 Basic UDI-DIs·8 Devices·GMED SAS

GE MEDICAL SYSTEMS Israel Ltd.

Manufacturer
🇮🇱 Israel

Carolina Lemke Ltd

Manufacturer
🇮🇱 Israel

Spectrum Dynamics Medical ltd

Manufacturer
🇮🇱 Israel·4 Basic UDI-DIs·12 Devices

CT/GAMMA CAMERA SYSTEMS

Device
EU MDR · Eu Md Class 2b ·GE Medical Systems Israel", Functional Imaging·On the market·32 countries

MyoSPECT ES

Device
EU MDR · Eu Md Class 2a ·GE Medical Systems Israel", Functional Imaging·On the market·32 countries

MyoSPECT

Device
EU MDR · Eu Md Class 2a ·GE Medical Systems Israel", Functional Imaging·On the market·23 countries

VERITON CT 464

Device
EU MDR · Eu Md Class 2b ·Spectrum Dynamics Medical ltd·On the market·5 countries

VERITON CT 416

Device
EU MDR · Eu Md Class 2b ·Spectrum Dynamics Medical ltd·On the market·5 countries

VERITON CT 364

Device
EU MDR · Eu Md Class 2b ·Spectrum Dynamics Medical ltd·On the market·6 countries

VERITON CT 316

Device
EU MDR · Eu Md Class 2b ·Spectrum Dynamics Medical ltd·On the market·2 countries

VERITON CT 264

Device
EU MDR · Eu Md Class 2b ·Spectrum Dynamics Medical ltd·On the market·5 countries

VERITON CT 216

Device
EU MDR · Eu Md Class 2b ·Spectrum Dynamics Medical ltd·On the market·6 countries

VERITON NM 300

Device
EU MDR · Eu Md Class 2a ·Spectrum Dynamics Medical ltd·On the market·3 countries

VERITON NM 400

Device
EU MDR · Eu Md Class 2a ·Spectrum Dynamics Medical ltd·On the market·1 country

VERITON NM 200

Device
EU MDR · Eu Md Class 2a ·Spectrum Dynamics Medical ltd·On the market·6 countries

TruSPECT

Device
EU MDR · Eu Md Class 2b ·Spectrum Dynamics Medical ltd·On the market·7 countries