10 results
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19ms
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Sources: EU EUDAMED, US FDA
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Country: Germany
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MANI MEDICAL GERMANY GmbH
Manufacturer
🇩🇪 Germany
MANI MEDICAL GERMANY GmbH
FDA registration
MANI MEDICAL GERMANY GmbH·3 products·🇩🇪 Germany
M. Bartels Reha Im-& Export GmbH
Importer
🇩🇪 Germany
Laser Fiber Assy-Single Use-LFS-272-RT-0.22NA-SMA905- Slim Extension Sleeve Silver-Sterile ETO- Private label: SU-200-RT SmartScope Packaging. The Laser peripherals bare laser fibers, ENT fibers and Endoprobes are intended for use in laser surgical procedure for cutting, coagulating, or vaporizing in any soft tissue application for which compatible Nd: YAG, Ho: YAG, KTP and Diode lasers have been cleared.
FDA Enforcement
Class II
·Terminated·Leoni Fiber Optics GmbH·December 19, 2018
Laser Fiber Assy-Single Use-LFS-550-RT-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO-Private label: SU-550-RT SmartScope Packaging. The Laser peripherals bare laser fibers, ENT fibers and Endoprobes are intended for use in laser surgical procedure for cutting, coagulating, or vaporizing in any soft tissue application for which compatible Nd: YAG, Ho: YAG, KTP and Diode lasers have been cleared.
FDA Enforcement
Class II
·Terminated·Leoni Fiber Optics GmbH·December 19, 2018
Laser Fiber Assy-Single Use-LFS-365-RT-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO- Private label: SU-365-RT SmartScope Packaging. The Laser peripherals bare laser fibers, ENT fibers and Endoprobes are intended for use in laser surgical procedure for cutting, coagulating, or vaporizing in any soft tissue application for which compatible Nd: YAG, Ho: YAG, KTP and Diode lasers have been cleared.
FDA Enforcement
Class II
·Terminated·Leoni Fiber Optics GmbH·December 19, 2018
Laser Fiber Assy-Single Use-LFS-200-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO-ForTec Fiber SU-200-TRUE-RT Label Smartscope packaging. The Laser peripherals bare laser fibers, ENT fibers and Endoprobes are intended for use in laser surgical procedure for cutting, coagulating, or vaporizing in any soft tissue application for which compatible Nd: YAG, Ho: YAG, KTP and Diode lasers have been cleared.
FDA Enforcement
Class II
·Terminated·Leoni Fiber Optics GmbH·December 19, 2018
Laser Fiber Assy-Single Use-LFS-940-RT-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO-Private label: SU-1000-RT SmartScope Packaging. The Laser peripherals bare laser fibers, ENT fibers and Endoprobes are intended for use in laser surgical procedure for cutting, coagulating, or vaporizing in any soft tissue application for which compatible Nd: YAG, Ho: YAG, KTP and Diode lasers have been cleared.
FDA Enforcement
Class II
·Terminated·Leoni Fiber Optics GmbH·December 19, 2018
M. Bartels Reha Im- & Export GmbH
Authorized representative
🇩🇪 Germany·1 Manufacturer
iRIS EYE GmbH
Importer
🇩🇪 Germany·3 Manufacturers