191 results · 20ms · Sources: EU EUDAMED, US FDA

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SP NEWTRON CAN-A; MODULE NEWTRON CAN-A EMB; SUPPORT XINETIC; NWT CAN SLIM LED CORD G3 SHORT; NWT CAN SLIM LED CORD G3 LONG

FDA 510(k)
FDA Class 2 ·Dental

LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C)

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

LUCEA LED

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Maquet SAS·29 devices

LUCEA LED

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Maquet SAS·6 devices

ROSA One 3.1 Brain application The device is intended for the spatial positioning and orientation of instruments holders or tool guides to be used by trained surgeons to guide standard surgical instruments during brain and spine surgeries.

FDA Enforcement
Class I ·Ongoing·MEDTECH SAS·November 3, 2021

Ortho Cape

Manufacturer
🇫🇷 France·82 Basic UDI-DIs·82 Devices·HTCert (Health Technology Certification Ltd), HTCert (Health Technology Certification Ltd), HTCert (Health Technology Certification Ltd), and HTCert (Health Technology Certification Ltd)

ISO Med

Manufacturer
🇫🇷 France·6 Basic UDI-DIs·6 Devices·HTCert (Health Technology Certification Ltd)

URGOSTART Plus Absorb

Device
EU MDR · Eu Md Class 2b ·LABORATOIRES URGO·On the market·5 countries

Mobile Dream standard abdominale poignée tournante droite rouge

Device
EU MDR · Eu Md Class 1 ·LAZELEC·On the market

3585C04210501

Certificate
MDD Annex II (excluding section 4)·Ortho Cape·HTCert (Health Technology Certification Ltd)·15 Basic UDI-DIs

2204C04210402

Certificate
MDD Annex II (excluding section 4)·ISO Med·HTCert (Health Technology Certification Ltd)·6 Basic UDI-DIs

3585c04210501

Certificate
MDD Annex II (excluding section 4)·Ortho Cape·HTCert (Health Technology Certification Ltd)·1 Basic UDI-DI

358504210501

Certificate
MDD Annex II (excluding section 4)·Ortho Cape·HTCert (Health Technology Certification Ltd)·2 Basic UDI-DIs

3585C04210501

Certificate
MDD Annex II (excluding section 4)·Ortho Cape·HTCert (Health Technology Certification Ltd)·64 Basic UDI-DIs

Int'Air Medical

Importer
🇫🇷 France·2 Manufacturers

NEEDLES AND KITS FOR IMPLANTABLE SYSTEMS (PORT), W/O SAFETY SYSTEMS

Device
EU MDD · Eu Md Class 2a ·ISO Med·On the market·32 countries

NEEDLES AND KITS FOR IMPLANTABLE SYSTEMS (PORT), W/O SAFETY SYSTEMS

Device
EU MDD · Eu Md Class 2a ·ISO Med·On the market·32 countries

NEEDLES AND KITS FOR IMPLANTABLE SYSTEMS (PORT), W/O SAFETY SYSTEMS

Device
EU MDD · Eu Md Class 2a ·ISO Med·On the market·32 countries

VEIN STRIPPER DEVICES

Device
EU MDD · Eu Md Class 2a ·ISO Med·On the market·32 countries

MI SCREW Ø3 lg 20mm

Device
EU MDD · Eu Md Class 2b ·Ortho Cape·On the market·32 countries