7 results
·
28ms
·
Sources: EU EUDAMED, US FDA
STRYKER ORAL MAX SYSTEM
FDA 510(k)
FDA Class 2
·Dental
TEMP MARQ(TM) CONVECTIVE WARMING SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
DIAMONDS BURS-COMPOSIT FINISHING
FDA 510(k)
FDA Class 1
·Dental
INSYNC III MARQUIS
FDA Adverse Event
Malfunction
·IPG MFG SWITZERLAND·Product code NIK·February 11, 2013
PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·January 10, 2011
STORZ BENGER HOOK
FDA Adverse Event
Injury
·BAUSCH & LOMB, INC.·Product code HNR·July 18, 2014
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