7 results
·
30ms
·
Sources: EU EUDAMED, US FDA
Filters
Country: Switzerland
×
Air Note GmbH
Manufacturer
🇨🇭 Switzerland·1 Basic UDI-DI·1 Device
CEROTTO PROFUMATO PER INCONTINENZA E STOMA
Device
EU MDR
·
Eu Md Class 1
·Air Note GmbH·On the market
CO-RE I 8xthousand
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Hamilton Bonaduz AG·1 device
CO-RE I Welcome CN
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Hamilton Bonaduz AG·1 device
The FEMTO LDV(TM)Z8 Femtosecond Surgical Laser The FEMTO LDV(TM)Z8 Femtosecond Surgical Laser is an ophthalmic surgical laser intended for use in the creation of corneal incisions indicated for use in patients undergoing LASIK surgery, tunnel creation for implantation of rings, pocket creation for implantation of corneal implants, lamellar keratoplasty, penetrating keratoplasty or other treatment requiring lamellar resection of the cornea at a varying depth with respect to the corneal surface. In addition, the FEMTO LDV(TM)Z8 Surgical Laser is intended for use in the creation of capsulotomy, phacofragmentation and the creation of single plane, multi-plane, arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure indicated for use in patients undergoing cataract surgery for removal of the crystalline lens.
FDA Enforcement
Class II
·Terminated·SIE AG, Surgical Instrument Engineering·April 4, 2018
CEROTTO PROFUMATO PER INCONTINENZA E STOMA
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·Air Note GmbH·1 device
SIE AG, Surgical Instrument Engineering
System producer
🇨🇭 Switzerland