8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
SPONGE COUNTER BAGS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
TRULY AUTOMATIC ARM BLOOD PRESSURE MONITORDB21,DB31,DB22,DB23,DB71M,DB32,DB61M, DB62M, DB63M
FDA 510(k)
FDA Class 2
·Cardiovascular
MULTI-CAVITY EQUILIBRIUM CELL
FDA 510(k)G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·May 5, 2014
CONSULTA CRT-P
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code OJX·October 15, 2012
ENVOY 5F GUIDING CATHETERS
FDA Adverse Event
Malfunction
·CODMAN AND SHURTLEFF, INC·Product code DQY·May 22, 2015
STAR/HEXDRIVE SCREWDRIVER T25 3.5MM HEX/SELF-RETAINING
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HXX·August 3, 2018
PROPONENT DR SL (Model L201)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025