7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
SYSTEMATE DIRECT BILIRUBIN CATALOG NO. 65406
FDA 510(k)
FDA Class 2
·Clinical Chemistry
S.L.T. CONTACT LASER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BIOPSY ATTACH. FOR ADMS ULTRASOUND PROBE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
RESOLUTION CLIP CLIPPING DEVICE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code KOG·June 25, 2014
GYNECARE X-TRACT MORCELLATOR
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code HET·January 3, 2013
MYNX VASCULAR CLOSURE DEVICE
FDA Adverse Event
Injury
·ACCESSCLOSURE, INC.·Product code MGB·November 10, 2010
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020