7 results
·
19ms
·
Sources: EU EUDAMED, US FDA
ABBOTT ARCHITECT FREE T4
FDA 510(k)
FDA Class 2
·Clinical Chemistry
iRestore Professional 282
FDA 510(k)
FDA Class 2
·Physical Medicine
INTRATEMP SOLUTION WARMER
FDA 510(k)
FDA Class 1
·Physical Medicine
TRANSPEDSCHANZSCR Ø6.2 L190/45 TAN DBLUE
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWC·February 28, 2013
ADAPTER SLEEVES 12/14 +2
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·January 31, 2011
NONE
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE INC.·Product code LZG·July 7, 2014
Exactech Equinoxe REVERSE SHOULDER,46mmConstrained Humeral Liner, a) +0mm, Item number 320-46-10, b) +2.5mm, Item Number 320-46-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024