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Device Recall GYC1000 Green Laser Photocoagulator system
Modelo / Serial
Model: GYC-1000; Serial numbers: 10018 10039 10040 10041 10042 10043 10044 10045 10046 10047 10048 10063 10064 10066 10067 10068 10072 10073 10074 10075 10079 10080 10081 10082 10083 10084 10085 10086 10087 10088 10108 10109 10110 10111 10112 10113 10114 10115 10116 10117 10146 10147 10148 10149 10150 10151 10152 10153 10154 10155 10162 10208 10209 10212 10213 10222 10225 10226 10238 10239 10242 10243 10244 10245 10272 10273 10274 10275 10276 10295 10296 10297 10298 10299 10300 10301 10302 10303 10304 10328 10329 10330 10331 10332 10333 10334 10335 10336 10337 10356 10357 10358 10359 10360 10361 10362 10363 10364 10365 10366 10367 10400 10401 10402 10403 10404 10405 10406 10429 10430 10431 10432 10433 10459 10461 10464 10465 10466 10491 10492 10493 10494 10537 10538 10539 10540 10541 10542 10543 10544 10545 10546 10547 10548 10549 10550 10566 10567 10568 10569 10570 10571 10572 10573 10594 10595 10596 10597 10598 10599 10600 10608 10609 10610 10611 10612 10613 10614 10615 10616 10651 10652 10653 10654 10655 10673 10674 10675 10676 10677 10678 10679 10680 10696 10697 10732 10766 10767 10768 10769 10770 10771 10772 10773 10798 10799 10800 10801 10802 10821 10822 10823 10824 10825 10826 10827 10828 10854 10855 10856 10857 10858 10859 10860 10904 10905 10906 10907 10908 10909 10910 10911 10912 10913 10957 10958 10959 10960 10992 10993 10994 11080 11081 11082 11083 11084 11119 11120 11121 11122 11123 11155 11156 11157 11192 11193 11194 11195 11196 11197 11198 11199 11236 11237 11238 11239 11240 11241 11242 11243 11244 11245 11261 11262 11263 11270 11271 11272 11273 11310 11311 11312 11313 11314 11315 11316 11317 11318 11319 11367 11368 11369 11370 11371 11372 11373 11406 11407 11408 11409 11410 11411 11412 11449 11450 11451 11568 11569 11601 11602 11603 11604 11605 11630 11631 11632 11633 11634 11635 11636 11637 11660 11661 11662 11663 11664 11724 11725 11726 11727 11728 11769 11770 11771 11791 11792 11793 11817 11818 11819 11820 11821 11863 11864 11865 11866 11867 11898 11899 11900 11901 11902 11903 11904 11905 11906 11907 11908 11909 11910 11911 11912 11941 11942 11943 11944 11945 11946 11947 11948 11949 11950 11992 11994 11995 11996 11997 11998 11999 12000 12001 12017 12018 12040 12041 12042 12043 12044 12069 12070 12071 12072 12074 12075 12148 12152 12156 12157 12210 12213 12215 12216 12253 12254 12255 12278 12279 12280 12301 12302 12303 12316 12317 12318 12319 12320 12322 12323 12346 12347 12348 12393 12394 12395 12396 12397 12398 12412 12413 12414 12424 12425 12449 12450 12480 12481 12482 12518 12519 12520 12551 12552 12553 12564 12565 12566 12594 12595 12596 12613 12614 12615 12644 12645 12646 12668 12669 12670 12671 12672 12673 12682 12683 12686 12687 12702 12703 12704 12710 12711 12712 12713 12714 12715 12716 12738 12739 12740 12741 12742 12743 12744 12768 12769 12770 12771 12772 12794 12795 12796 12797 12798 12829 12830 12831 12832 12859 12860 12861 12864 12865 12884 12885 12886 12915 12916 12917 12936 12937 12938 12939 12940 12941 12942 12943 12948 12949 12950 12951 12958 12959 12960 12961 12962 12974 12975 12976 12977 12978 13069 13070 13071 13099 13100 13101 13149 13151 13169 13170 13171 13172 13173 13182 13183 13184 13187 13188 13189 13190 13191 13192 13193 13206 13207 13208 13209 13210 13211 13212 13220 13221 13222 13223 13224 13244 13245 13246 13314 13315 13326 13327 13328 13329.
Clasificación del producto
General and Plastic Surgery Devices
Clase de dispositivo
2
¿Implante?
No
Distribución
USA (nationwide) Distribution
Descripción del producto
GYC-1000 Green Laser Photocoagulator system || The Nidek Green Laser Photocoagulator Model GYC -1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.
Manufacturer
Nidek Inc
1 Event
Retiro De Equipo (Recall) de Device Recall GYC1000 Green Laser Photocoagulator system
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Fabricante
Nidek Inc
Dirección del fabricante
Nidek Inc, 47651 Westinghouse Dr, Fremont CA 94539-7474
Empresa matriz del fabricante (2017)
Nidek Co. Ltd.
Source
USFDA
Language
English
Français
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한국어