10 results
·
20ms
·
Sources: EU EUDAMED, US FDA
TINA-QUANT CERULOPLASMIN
FDA 510(k)
FDA Class 2
·Immunology
WAVEWRITER ALPHA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 27, 2023
RADIONICS RF DISC CATHETER ELECTRODE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CRIT-LINE MONITOR III TQA (CLM TQA)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code NIQ·February 7, 2019
GAS MODULE III RESPIRATION GAS MONITOR
FDA Adverse Event
Malfunction
·MINDRAY DS USA, INC.·Product code BZK·April 30, 2013
GRANUFLO
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·August 25, 2014
ISOLINE
FDA Adverse Event
Injury
·SORIN BIOMEDICA CRM S.R.L.·Product code MRM·May 17, 2011
PERCLOSE¿ PROSTYLE¿
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR INC.·Product code MGB·February 5, 2026
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