9 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Yomi Robotic System
FDA 510(k)
FDA Class 2
·Dental
iTero Lumina Pro
FDA UDI
Align Technology, Inc.·00816063022664·iTero Lumina Pro US Scanning Unit, RMA
MODIFICATION TO RAICHEM CALCIUM REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
NEUROPRO LOW PROFILE CRANIAL PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 13, 2025
1688 AIM 4K CAMERA HEAD WITH INTEGRATED COUPLER - INTERNATIONAL KIT
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY-SAN JOSE·Product code GCJ·September 13, 2024
MEDTRONIC ANEURX BIFURCATED STENT GRAFT (FLEXIBLE)
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR·Product code MIH·November 6, 2008
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·August 17, 2011
AFFINITIY THREE BIRTHING BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code HDD·July 5, 2013