9 results
·
29ms
·
Sources: EU EUDAMED, US FDA
FLOWPICC CONSOLE
FDA 510(k)
FDA Class 2
·Cardiovascular
HALLU PLATES
FDA 510(k)
FDA Class 2
·Orthopedic
CONCORD 72
FDA 510(k)
FDA Class 2
·Dental
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 8, 2025
WAVEWRITER ALPHA?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·August 25, 2025
STERRAD 200, SINGLE DOOR
FDA Adverse Event
Malfunction
·ADVANCED STERILIZATION PRODUCTS·Product code MLR·April 29, 2013
CDP UNKNOWN
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES DR·Product code DXO·May 9, 2011
UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEMS
FDA Adverse Event
Other
·BECKMAN COULTER, INC.·Product code JJE·July 16, 2008
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018