10 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
IMMULITE 2000: C-PEPTIDE CALIBRATION VERIFICATION MATERIAL, SHBG CALIBRATION VERIFICATION MATERIAL, TOTAL TESTOSTERONE C
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Gyrus ACMI
FDA UDI
Gyrus ACMI, LLC·00821925017665·SHEA MALLEUS ATTACHMENT PISTON SMALL HEAD, LEFT...
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017774·K-Wire, Double Ended, Trocar Point, Diameter Si...
MAMMOSOURCE HIGH DOSE RATE (HDR) REMOTE AFTERLOADER
FDA 510(k)
FDA Class 2
·Radiology
FIGURE 8 STERNOTOMY CLOSURE DEVICE
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 4, 2025
LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC·Product code MKJ·May 31, 2013
DEPUY PINNACLE
FDA Adverse Event
Injury
·DEPUY·Product code KWA·June 21, 2011
ANALYTICAL D MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·August 28, 2008
3.0 RIO® ROBOTIC ARM - MICS
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code OLO·January 11, 2017