7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
CARDIO2 CYCLE
FDA 510(k)
FDA Class 1
·Cardiovascular
BARD 4-WIRE URETEROSCOPIC STONE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
OLYMPUS CALCIUM REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL ¿ NEUROMODULATION·Product code GZB·June 2, 2014
ACCOLADE STEM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS CORK·Product code MEH·January 16, 2013
TERUMO CDI 540 CALIBRATOR
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·November 11, 2010
Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025