7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
ANNULUS VALVULOTOME
FDA 510(k)
FDA Class 2
·Cardiovascular
BPTRU AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-100
FDA 510(k)
FDA Class 2
·Cardiovascular
CYTOGUARD(TM) CLOSED LUER CONNECTOR
FDA 510(k)
FDA Class 2
·General Hospital
LC PCA REFURB 802.11
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code MEA·May 14, 2014
ACCU-CHEK ® AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·January 14, 2013
DEXTRUS 4136
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVZ·November 24, 2010
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015