10 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Corin TaperFit Hip Stem
FDA 510(k)
FDA Class 2
·Orthopedic
Temporary Abutment
FDA UDI
BICON, LLC·00813110028754·5.0 x 2.5mm Scannable Temporary Abutment - 2.0m...
VIRTUOST
FDA 510(k)
FDA Class 2
·Radiology
FASTPACK CONTROL KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 28, 2024
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 8, 2014
SPRINT QUATTRO SECURE
FDA Adverse Event
Malfunction
·MPRI·Product code LWS·June 8, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 7, 2011
Precise Digital Accelerator Intended to be used for radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·February 18, 2015
ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023