10 results
·
25ms
·
Sources: EU EUDAMED, US FDA
TANDEM PROLACTIN KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
STRADIS
FDA UDI
STRADIS MEDICAL, LLC·M75268215451·CUSTOM CONVENIENCE KIT PHLEBECTOMY
STRADIS HEALTHCARE
FDA UDI
STRADIS MEDICAL, LLC·M7526821545R10·
BELLYBOARD, SBRT ACCESSORIES
FDA 510(k)
FDA Class 2
·Radiology
MectaLIF Anterior Extension
FDA 510(k)
FDA Class 2
·Orthopedic
MECTALIF ANT - LAG
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code OVD·April 12, 2024
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·May 20, 2014
PWRD ECH FLEX 60MM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·November 6, 2012
M2A MAGNUM MODULAR HEAD
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code KWA·August 27, 2010
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018