10 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Vantage PSI System
FDA 510(k)
FDA Class 2
·Orthopedic
K231485
FDA Adverse Event
Malfunction
·BETA BIONICS, INC.·Product code QFG·October 25, 2025
U&I, OPTIMA, SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
INTEL-GE CARE INNOVATIONS QUIETCARE
FDA 510(k)
FDA Class 1
·General Hospital
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 21, 2025
1.7MM COCR CABLE WITH TI CRIMP 750MM-STERILE
FDA Adverse Event
Malfunction
·SYNTHES SELZACH·Product code JDQ·June 12, 2017
TI CERVICAL SPINE LOCKING PLATE VARIABLE ANGLE
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HRS·November 13, 2008
RESPIRONICS 920M
FDA Adverse Event
Other
·NONIN MEDICAL, INC.·Product code DQA·August 22, 2011
CHARGING SYS
FDA Adverse Event
Injury
·ST JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 12, 2013
Revogene, Catalog no. 610210. IVD test instrument
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·August 3, 2022