7 results
·
27ms
·
Sources: EU EUDAMED, US FDA
I-125 ANTI-THYROGLOBULIN ANTIBODY IRMA TEST KIT
FDA 510(k)
FDA Class 2
·Immunology
VIDAR VISION 3000 AND 4000 X-RAY SYSTEMS
FDA 510(k)
FDA Class 2
·Radiology
Certa Catheter
FDA 510(k)
FDA Class 2
·Anesthesiology
MALLINCKRODT
FDA Adverse Event
Malfunction
·COVIDIEN·Product code BTS·April 14, 2014
TELIGEN
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 15, 2010
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 12, 2012
Aftermarket Alaris Infusion Pump Module Model 8100 Front Bezel, installed by Pacific Medical Group (DBA Avante Health Solutions)
FDA Enforcement
Class I
·Ongoing·Pacific Medical Group Inc.·April 28, 2021