12 results
·
20ms
·
Sources: EU EUDAMED, US FDA
ABBOTT AXSYM TROPONIN-I ADV
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Tiche PTA Balloon Dilatation Catheter
FDA UDI
BrosMed Medical Co.,Ltd.·06958481476354·
HYCARE LATEX EXAMINATION GLOVE, POWDERED
FDA 510(k)
FDA Class 1
·General Hospital
ASSAYED QCS 1,2, CAT. NOS. 970200, 970500
FDA 510(k)
FDA Class 1
·Clinical Chemistry
LIBERTE' MONORAIL CORONARY STENT DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code MAF·December 22, 2006
OLYMPUS WORKSTATION TRANSFORMER
FDA Adverse Event
Malfunction
·KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT), LTD.·Product code FEM·April 10, 2013
TERUMO CDI 500 BLOOD PARAMETER MONITOR
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·March 14, 2011
UVSL COMMAND MODULE
FDA Adverse Event
Injury
·SPACELABS MEDICAL INC.·Product code DSI·June 13, 2008
BD MULTITEST¿ 6-COLOR TBNK REAGENT W/BD TRUCOUNT¿ TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·May 20, 2022
BD MULTITEST¿ 6-COLOR TBNK
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code GKZ·January 31, 2024
BD MULTITEST¿ 6-COLOR TBNK
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code GKZ·January 31, 2024
Contour¿ next GEN Blood Glucose Monitoring System
FDA Enforcement
Class II
·Ongoing·Ascensia Diabetes Care US, Inc.·July 26, 2023