10 results
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33ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CASABLANCA
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Measuring Device
FDA UDI
ADLER ORTHO SPA·08050507139323·SICKLE-SHAPED MEASURING DEVICE
ReLine
FDA UDI
Nuvasive, Inc.·00195377021007·RELINE-C Ti Rod, 3.5x600mm Straight
QWIKCHECK-BEADS
FDA 510(k)
FDA Class 2
·Hematology
NANOSS BIOACTIVE, NANOSS BIOACTIVE LOADED, AND NANOSS BIOACTIVE LOADED KIT
FDA 510(k)
FDA Class 2
·Orthopedic
EZ GLIDE AORTIC CANNULA
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DWF·May 30, 2014
GOBED II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·October 22, 2012
AKREOS ADAPT AO MICRO INCISION LENS
FDA Adverse Event
Injury
·BAUSCH + LOMB·Product code HQL·September 16, 2010
XP-XP Tibial Tray - Interlok 71 mm Item # 195755
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 18, 2019
Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution and Storage) with remote fill is intended to be used in Hemodialysis facilities for the storage and distribution of acid concentrate to be used in the treatment of Hemodialysis patients Model: ACDS MD704262
FDA Enforcement
Class II
·Terminated·Isopure Corp·September 21, 2022