20 results · 26ms · Sources: EU EUDAMED, 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