31 results · 35ms · Sources: EU EUDAMED, US FDA

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NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01)

FDA 510(k)
FDA Class 2 ·Cardiovascular

INRATIO

FDA Adverse Event
Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·November 23, 2010

MD302C4 29.8 DIAGNOSTIC IMAGING LCD MONITOR

FDA 510(k)
FDA Class 2 ·Radiology

MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

INRATIO2

FDA Adverse Event
Injury ·BIOSITE INCORPORATED·Product code GJS·June 29, 2010

INRATIO

FDA Adverse Event
Malfunction ·ALERE SAN DIEGO, INC·Product code GJS·January 10, 2011

BD SYRINGE 10ML LL BNS

FDA Adverse Event
Malfunction ·BECTON DICKINSON DE MEXICO·Product code FMF·April 30, 2025

INRATIO

FDA Adverse Event
Malfunction ·BIOSITE INCORPORATED·Product code GJS·August 6, 2010

INRATIO

FDA Adverse Event
Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·November 9, 2010

INRATIO

FDA Adverse Event
Malfunction ·ALERE SAN DIEGO, INC·Product code GJS·December 2, 2010

INRATIO

FDA Adverse Event
Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·January 21, 2011

INRATIO

FDA Adverse Event
Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·January 28, 2011

INRATIO

FDA Adverse Event
Other ·ALERE SAN DIEGO, INC·Product code GJS·April 5, 2011

INRATIO

FDA Adverse Event
Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·November 5, 2010

IVT DISPOSABLE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SAO PAULO·Product code KPE·September 2, 2011

OT ULTRALINK METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 18, 2013

HLED

FDA Adverse Event
Malfunction ·MAQUET SAS·Product code FSY·November 18, 2015

INRATIO

FDA Adverse Event
Malfunction ·ALERE SAN DIEGO, INC·Product code GJS·November 4, 2010

INRATIO

FDA Adverse Event
Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·September 23, 2010

INRATIO

FDA Adverse Event
Malfunction ·ALERE SAN DIEGO, INC·Product code GJS·September 27, 2010