55 results
·
35ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
CXI SUPPORT CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
SMITH & NEPHEW VASCULAR VIDEOENDOSCOPE SYSTEM, MODEL 7209273
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NUMALINK
FDA 510(k)
FDA Class 2
·Radiology
INRATIO
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO INC·Product code GJS·October 26, 2010
INRATIO
FDA Adverse Event
Malfunction
·BIOSITE INCORPORATED·Product code GJS·June 3, 2010
INRATIO
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·July 1, 2011
INRATIO
FDA Adverse Event
Other
·ALERE SAN DIEGO, INC.·Product code GJS·October 26, 2010
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 23, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 29, 2011
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·July 10, 2008
COULTER LH 750 HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·March 31, 2016
INRATIO
FDA Adverse Event
Malfunction
·BIOSITE INCORPORATED·Product code JPA·May 10, 2010
INRATIO
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·June 12, 2012
INRATIO
FDA Adverse Event
Malfunction
·BIOSITE INCORPORATED·Product code GJS·May 10, 2010
OT SURESTEP METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·March 31, 2011
INRATIO2 PT MONITORING SYSTEM
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·September 11, 2015
INRATIO2 PT MONITORING SYSTEM
FDA Adverse Event
Injury
·ALERE SAN DIEGO, INC.·Product code GJS·September 14, 2015
INRATIO2 PT MONITORING SYSTEM
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·August 3, 2015
OT SURESTEP ENHANCED METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·August 23, 2011
INRATIO2 PT MONITORING SYSTEM
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·February 4, 2015