2 results
·
15ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
×
GE Healthcare Versana Ultrasound Systems, sold under the following names and Model/Catalog Numbers: 1) Versana Premier R3 VS, Model/Catalog Number 5938558; 2) Versana Premier R3 VA, Model/Catalog Number 5938559; 3) Versana Premier Lotus 4PP, Model/Catalog Number 5938560; 4) Versana Premier Lotus 5PP, Model/Catalog Number 5938561; 5) Versana Premier R3 VA Vet, Model/Catalog Number 5946387; 6) Versana Premier R3 VS Vet, Model/Catalog Number 5946481. 7) Versana Premier R3 Expert, Model/Catalog Number 5946950; 8) Versana Premier R3, Model/Catalog Number 5946951; 9) Versana Premier R3 Pro, Model/Catalog Number 5946952; 10) Versana Premier R3 Elite, Model/Catalog Number 5946953; 11) Versana Premier R3 Plus, Model/Catalog Number 5946954; 12) Versana Premier R3 Ultra, Model/Catalog Number 5946955; 13) Versana Premier R3 Max, Model/Catalog Number 5946956; 14) Versana Premier R3 Super, Model/Catalog Number 5946957; 15) Versana Premier R3 VS India, Model/Catalog Number 5948398; 16) Versana Premier R3 VA India, Model/Catalog Number 5948399; diagnostic ultrasound system
FDA Enforcement
Class II
·Ongoing·GE Medical Systems China Co., Ltd.·July 2, 2025
Compress, Mini Compress; Item Nos. 178350 178351 178352 178353 178354 178355 178356 178357 178358 178359 178360 178361 178362 178363 178364 178365 178366 178367 178368 178369 178370 178371 178372 178373 178464 178472 178480 178488 178496 178504 178575 178576 178577 178578 178579 178580 178730 178731 178732 178733 178734 178735 178354S 178754 178755 178756 178757 178758 178759 Product Usage: 1) Correction of revision of unsuccessful osteotomy, arthrodesis or previous joint replacement 2) Tumor resections 3) Revision of previously failed total joint arthroplasty 4) Trauma The ComPreSs Distal Femoral Replacement System is intended for uncemented use.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 4, 2019