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Sources: EU EUDAMED, US FDA
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Country: Switzerland
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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
Atesos medical AG
Manufacturer
🇨🇭 Switzerland·192 Basic UDI-DIs·192 Devices·Schweizerische Vereinigung für Qualitäts- und Managementsysteme, Schweizerische Vereinigung für Qualitäts- und Managementsysteme, Schweizerische Vereinigung für Qualitäts- und Managementsysteme, and Schweizerische Vereinigung für Qualitäts- und Managementsysteme
Keri Medical SA
Manufacturer
🇨🇭 Switzerland·13 Basic UDI-DIs·15 Devices·Schweizerische Vereinigung für Qualitäts- und Managementsysteme and Schweizerische Vereinigung für Qualitäts- und Managementsysteme
KeriFix
Device
EU MDD
·
Eu Md Class 2b
·Keri Medical SA·On the market·19 countries
KeriLock
Device
EU MDD
·
Eu Md Class 2b
·Keri Medical SA·On the market·16 countries
KeriLock
Device
EU MDD
·
Eu Md Class 2b
·Keri Medical SA·On the market·16 countries
KeriFix
Device
EU MDD
·
Eu Md Class 2b
·Keri Medical SA·On the market·20 countries
Unas Short Stem
Device
EU MDD
·
Eu Md Class 3
·Atesos medical AG·On the market·2 countries
Unas Short Stem
Device
EU MDD
·
Eu Md Class 3
·Atesos medical AG·On the market·2 countries
Unas Short Stem
Device
EU MDD
·
Eu Md Class 3
·Atesos medical AG·On the market·2 countries
Unas Short Stem
Device
EU MDD
·
Eu Md Class 3
·Atesos medical AG·On the market·2 countries
Pyramid Hip Stem
Device
EU MDD
·
Eu Md Class 3
·Atesos medical AG·On the market·2 countries
Pyramid Hip Stem
Device
EU MDD
·
Eu Md Class 3
·Atesos medical AG·On the market·2 countries
Pyramid Hip Stem
Device
EU MDD
·
Eu Md Class 3
·Atesos medical AG·On the market·2 countries
Pyramid Hip Stem
Device
EU MDD
·
Eu Md Class 3
·Atesos medical AG·On the market·2 countries
Pyramid Hip Stem
Device
EU MDD
·
Eu Md Class 3
·Atesos medical AG·On the market·2 countries
Pyramid Hip Stem
Device
EU MDD
·
Eu Md Class 3
·Atesos medical AG·On the market·2 countries
Pyramid Hip Stem
Device
EU MDD
·
Eu Md Class 3
·Atesos medical AG·On the market·2 countries
Pyramid Stem lateral
Device
EU MDD
·
Eu Md Class 3
·Atesos medical AG·On the market·2 countries
Pyramid Stem lateral
Device
EU MDD
·
Eu Md Class 3
·Atesos medical AG·On the market·2 countries