7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
GENESIS II 7.5MHZ ULTRASOUND TRANSDUCER
FDA 510(k)
FDA Class 2
·Cardiovascular
UR 150-UR 150T
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
GLUCOSE HEXOKINASE, AUTO K
FDA 510(k)
FDA Class 2
·Clinical Chemistry
LEAD LOCKING DEVICE
FDA Adverse Event
Death
·SPECTRANETICS CORPORATION·Product code DRB·December 20, 2012
MARQUIS SERIES STOPCOCKS
FDA Adverse Event
Malfunction
·MERIT MEDICAL SYSTEMS, INC.·Product code DTL·October 11, 2010
COAGUCHEK ® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·June 18, 2014
GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stryker Trauma GmbH, Prof.-Kuntscher-Strasse 1-5, Schonkirchen, Germany 24232; T2 K-Wire, Sterile R Intended for the temporary stabilization of bone segments or fragments
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·December 28, 2016