9 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Saberscope5 Laparoscope
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SYNTHES 3.5 MM BROAD LC-DCP PLATES
FDA 510(k)
FDA Class 2
·Orthopedic
ASANTE CONSET AND ASANTE COMFORT SUBCUTANEOUS INFUSION SETS FOR USE WITH ASANTE PEARL INFUSION PUMPS
FDA 510(k)
FDA Class 2
·General Hospital
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·November 28, 2014
LIFEVEST WCD 3000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·October 29, 2008
FREESTYLE LITE
FDA Adverse Event
Malfunction
·Product code NBW·August 23, 2011
1.5MM TI CORTEX SCREW SELF-TAPPING 11MM
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code MQN·July 11, 2013
ASANTE SNAP INSULIN PUMP SYSTEM
FDA Adverse Event
Injury
·ASANTE SOLUTIONS INC.·Product code LZG·August 11, 2014
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025