20 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MODIFICATION TO THE MAESTRO SYSTEM
FDA 510(k)
FDA Class 2
·Dental
BUSCH®, BNA®
FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120304631·Diamond, cylinder flat, medium grit
IMMULITE H. PYLORI IGG AND IMMULITE 2000 H. PYLORI IGG
FDA 510(k)
FDA Class 1
·Microbiology
SOCON SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
C21617 DE LIFE SYSTEMS $PHISIO
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·October 24, 2013
ENDURANT STENT GRAFT
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·July 1, 2020
ENDURANT STENT GRAFT
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code MIH·July 1, 2020
KNIFE
FDA Adverse Event
Malfunction
·ALCON PRECISION DEVICE - SINKING SPRING·Product code HNN·March 27, 2013
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·March 9, 2011
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·April 16, 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
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012