15 results · 24ms · Sources: EU EUDAMED, US FDA

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Discovery MI

FDA 510(k)
FDA Class 2 ·Radiology

COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632

FDA 510(k)
FDA Class 2 ·Hematology

ARK GABAPENTIN ASSAY, ARK GABEPENTIN CALIFRATOR, AND ARK GABAPENTIN CONTROL MODEL5025-0001-00, 5025-0002-00, 5025-0003-0

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

COULTER LH 750 HEMATOLOGY ANALYZER

FDA Adverse Event
Malfunction ·BECKMAN COULTER·Product code GKZ·March 31, 2016

COOK TURBO-FLO HD HEMODIALYSIS CATHETER TRAY

FDA Adverse Event
Malfunction ·COOK INC·Product code MPB·December 19, 2016

NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

FDA Adverse Event
Injury ·HOLOGIC·Product code MNB·May 6, 2013

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·July 14, 2011

CAPSUREFIX NOVUS

FDA Adverse Event
Malfunction ·MPRI·Product code DTB·October 10, 2014

COOK TURBO-FLO HD HEMODIALYSIS CATHETER TRAY

FDA Adverse Event
Injury ·COOK INC·Product code MPB·August 1, 2018

COOK TURBO-FLO HD HEMODIALYSIS CATHETER SET

FDA Adverse Event
Injury ·COOK INC·Product code MPB·June 13, 2017

COOK TURBO-FLO HD HEMODIALYSIS CATHETER TRAY

FDA Adverse Event
Injury ·COOK INC·Product code MPB·January 14, 2020

COOK TURBO-FLO HD HEMODIALYSIS CATHETER TRAY

FDA Adverse Event
Injury ·COOK INC·Product code MPB·January 14, 2020

COOK TURBO-FLO HD HEMODIALYSIS CATHETER SET

FDA Adverse Event
Injury ·COOK INC·Product code MPB·March 19, 2018

COOK TURBO-FLO HD HEMODIALYSIS CATHETER TRAY

FDA Adverse Event
Injury ·COOK INC·Product code MPB·June 7, 2018

COOK TURBO-FLO HD HEMODIALYSIS CATHETER TRAY

FDA Adverse Event
Injury ·COOK INC·Product code MPB·July 11, 2019