3 results
·
7ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
×
Tornado Embolization Microcoil, RPN GPN MWCE-18S-5/2-TORNADO G08356 MWCE-18S-6/2-TORNADO G08259 MWCE-18S-3/2-TORNADO-01 G47416 MWCE-18S-4/2-TORNADO-01 G47417 MWCE-18S-3/2-TORNADO-081800 G13102 MWCE-18S-3/2-TORNADO G08261 MWCE-18S-4/2-TORNADO-081800 G13103 MWCE-18S-4/2-TORNADO G08357 MWCE-18S-5/2-TORNADO-01 G47418 MWCE-18S-6/2-TORNADO-01 G47419 MWCE-18S-6/2-TORNADO-081800 G13105 MWCE-18S-5/2-TORNADO-081800 G13104 MWCE-18S-2/4-TORNADO-LEF G09945 MWCE-18S-2/5-TORNADO-LEF-081800 G13108 MWCE-18S-4/3-TORNADO G12924 MWCE-18S-2/3-TORNADO-LEF G09944 MWCE-18S-2/3-TORNADO-LEF-081800 G13106 MWCE-18S-2/4-TORNADO-LEF-081800 G13107
FDA Enforcement
Class II
·Ongoing·Cook Incorporated·June 15, 2022
Nester Embolization Microcoil RPN GPN MWCE-18-5-2-NESTER G52733 MWCE-18-5-3-NESTER G52734 MWCE-18-7-3-NESTER-01 G47338 MWCE-18-7-2-NESTER-01 G47337 MWCE-18-7-5-NESTER-01 G47340 MWCE-18-3-2-NESTER G52731 MWCE-18-7-8-NESTER-01 G47342 MWCE-18-7-8-NESTER G52739 MWCE-18-7-5-NESTER G23521 MWCE-18-3-3-NESTER G52732 MWCE-18-5-3-NESTER-01 G47334 MWCE-18-7-6-NESTER G52738 MWCE-18-7-6-NESTER-01 G47341 MWCE-18-3-3-NESTER-01 G47332 MWCE-18-7-4-NESTER G52737 MWCE-18-7-3-NESTER G52736 MWCE-18-3-2-NESTER-01 G47331 MWCE-18-5-2-NESTER-01 G47333 MWCE-18-2-2-NESTER-01 G47344 MWCE-18-5-5-NESTER-01 G47335 MWCE-18-7-2-NESTER G52735 MWCE-18-7-4-NESTER-01 G47339 MWCE-18-7-10-NESTER G52741 MWCE-18-5-5-NESTER G23520
FDA Enforcement
Class II
·Ongoing·Cook Incorporated·June 15, 2022
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020