21 results
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33ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN PROGESTERONE RECEPTOR ANTIBODY (CLONE SP2)
FDA 510(k)
FDA Class 2
·Hematology
NM3 Monitor, Spanish
FDA UDI
Respironics Novametrix, LLC·00884838015685·
URINE PHENCYCLIDINE (PCP) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 94A
FDA 510(k)
FDA Unclassified
·Unknown
AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES)
FDA 510(k)
FDA Class 2
·General Hospital
C21617 DE LIFE SYSTEMS $PHISIO
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·October 24, 2013
PROSPACE PEEK IMPLANT 5 7X8X22MM
FDA Adverse Event
Malfunction
·AESCULAP AG AND CO. KG·Product code MAX·June 21, 2013
TSPACE PEEK IMPLANT 26X11X7MM
FDA Adverse Event
Malfunction
·AESCULAP IMPLANT SYSTEMS·Product code MAX·October 30, 2015
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 10, 2013
ASR UNI FEMORAL IMPL SIZE 46
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·April 6, 2011
HI-TORQUE TRAVERSE GUIDE WIRE
FDA Adverse Event
Injury
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code DQX·June 13, 2008
CP82200 I MIRANDOLA
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·April 6, 2012
CP85341 FR PARIS
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·July 15, 2011
EMORY/CL/KNNSTN ATLANTA GA1
FDA Adverse Event
Other
·SORIN GROUP USA·Product code DWF·August 19, 2010
DUKE UNIV DURHAM NC 1
FDA Adverse Event
Other
·SORIN GROUP USA, INC.·Product code DWF·July 15, 2011
COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC COATING
FDA Adverse Event
Death
·SORIN GROUP ITALIA SRL·Product code KFM·November 23, 2016
COBE CARDIOVASCULAR REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC COATING
FDA Adverse Event
SORIN GROUP ITALIA·Product code KFM·February 29, 2016
REVOLUTION CENTRIFUGAL BLOOD PUMP
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code KFM·July 20, 2018
COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC COATING
FDA Adverse Event
Death
·SORIN GROUP ITALIA SRL·Product code KFM·October 6, 2016
COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC COATING
FDA Adverse Event
SORIN GROUP ITALIA SRL·Product code KFM·October 5, 2016
PHILIPS NM3 Monitor Model Number: 7900 PHILIPS NM3 Monitor, English Part Number: 1051674 PHILIPS NM3 Monitor, English, Refurbished Part Number : U1051674 PHILIPS NM3 Monitor, English, Demo Unit Part Number: DU1051674 PHILIPS NM3 Monitor, Spanish Part Number: 1060462 PHILIPS NM3 Monitor, French Part Number: 1060458 PHILIPS NM3 Monitor, Swedish Part Number:1062860 Intended use: Cardiac output monitoring, Spirometric and carbon dioxide monitoring, and Continuous, non-invasive monitoring of functional arterial oxygen saturation and pulse rate.
FDA Recall
Terminated
·Respironics Novametrix, LLC.·Product code BZK·July 29, 2011