8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Switzerland
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GUM AFTACLEAR SPRAY
Device
EU MDD
·
Eu Md Class 2a
·Sunstar Europe SA·On the market·24 countries
SWISS PHARMA DYNAMIC LTD Zweigniederlassung
Manufacturer
🇨🇭 Switzerland·1 Basic UDI-DI·1 Device·NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY
Derma Zartaux Fill +GF
Device
EU MDD
·
Eu Md Class 3
·SWISS PHARMA DYNAMIC LTD Zweigniederlassung·On the market·1 country
GUM AFTACLEAR SPRAY
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·Sunstar Europe SA·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
SIE AG, Surgical Instrument Engineering
System producer
🇨🇭 Switzerland
Derma ZARTAUX FILL +GF
Basic UDI-DI
EU MDD
·
Eu Md Class 3
·SWISS PHARMA DYNAMIC LTD Zweigniederlassung·1 device
301001846
Certificate
MDD Annex II (excluding section 4)·SWISS PHARMA DYNAMIC LTD Zweigniederlassung·NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY·1 Basic UDI-DI