191 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Country: France
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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