7 results
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26ms
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Sources: EU EUDAMED, US FDA
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Country: Taiwan
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GM3 SERIES IF TENS, MODEL GM3X2IF (WHERE X IS A PARAMETER OF DIFFERENT HOUSING)
FDA 510(k)
FDA Class 2
·Neurology
USTAR II Hip System Press-Fit Curved Stem, RHS Ti Plasma Spray for the following reference numbers: REF: PE11151211 - 11x150mm, PE11151213 - 13x150mm, PE11151215 - 15x150mm, PE11151217 - 17x150mm, PE11151411 - 11x200mm, PE11151413 - 13x200mm, PE11151415 - 15x200mm, PE11151417 - 17x200mm,
FDA Enforcement
Class II
·Ongoing·United Orthopedic Corporation·March 6, 2024
USTAR II Knee System Cemented curved stem, RHS, Non Coated for the following reference numbers: REF: PE25153109 - 9x125mm, PE25153209 - 9x150mm, PE25153113 - 13x125mm, PE25153111- 11x125mm, PE25153115 - 15x125mm, PE25153211 - 11x150mm, PE25153213 - 13x150mm, PE25153217 - 17x150mm, PE25153117 - 17x125mm, PE25153015 - 15x100mm, PE25153215 - 15x150mm
FDA Enforcement
Class II
·Ongoing·United Orthopedic Corporation·March 6, 2024
USTAR II Knee System : Cemented Curved Stem, RHS Ti Plasma Spray, Reference Numbers: REF: PE25153109 - PE25151109 - 9x125mm, PE25151111 - 11X125, PE25151113 - 13X125mm, PE25151115 - 15X125mm, PE25151117 - 17X125mm, PE25151119 - 19X125mm, PE25151209 - 9X150mm, PE25151211 - 11X150, PE25151213 - 13X150mm, PE25151215 - 15X150mm, PE25151217 - 17X150mm, PE25151415 - 15x200mm
FDA Enforcement
Class II
·Ongoing·United Orthopedic Corporation·March 6, 2024
Katsura Biological Corp
Manufacturer
🇹🇼 Taiwan·1 Basic UDI-DI·1 Device
Katsura Biological Coporation
Device
EU IVDR
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Eu Ivd Class A
·Katsura Biological Corp·On the market
S2R16B Fully Integrated Diagnostics Platform
Basic UDI-DI
EU IVDR
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Eu Ivd Class A
·Katsura Biological Corp·1 device