12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TSY SHOULDER PLATE IMPLANT
FDA 510(k)
FDA Class 2
·Orthopedic
CD HORIZON® Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00885074037363·BONE SCREW 7040850 ILIAC 8.5X50 TI
3D
FDA UDI
Rmo, Inc.·00885797100245·WILSON TOOL KIT
Cortera
FDA UDI
Xtant Medical Holdings, Inc.·00840311210541·Tap, Cann, Jacobs, 8.5
NA
FDA UDI
Summit Medical, Inc.·00385640001199·
POLESTAR N-10
FDA 510(k)
FDA Class 2
·Radiology
GPF-29 GENERAL PURPOSE COIL SET
FDA 510(k)
FDA Class 2
·Radiology
FUSION TITAN DILATION BALLOON
FDA Adverse Event
Malfunction
·COOK INC·Product code FGE·May 4, 2018
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·April 8, 2013
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·March 22, 2011
CIDEX PLUS 28 DAY SOLUTION
FDA Adverse Event
Malfunction
·JOHNSON & JOHNSON·Product code LRJ·May 9, 2008
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