25 results · 40ms · Sources: EU EUDAMED, US FDA

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BriefCase

FDA 510(k)
FDA Class 2 ·Radiology

MIS Lance+ Conical Connection Dental Implant System

FDA 510(k)
FDA Class 2 ·Dental

AVERA MODEL DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM)

FDA 510(k)
FDA Class 2 ·Radiology

GLP TRACK END

FDA Adverse Event
Malfunction ·ABBOTT AUTOMATION SOLUTIONS GMBH·Product code JQP·May 18, 2026

SYNCHROMED II

FDA Adverse Event
Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·March 27, 2016

RAPIDPOINT 400

FDA Adverse Event
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS, LTD.·Product code JGS·October 27, 2008

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·August 17, 2011

PRECISE PRO RX CAROTID STENT SYSTEM

FDA Adverse Event
Injury ·CORDIS DE MEXICO·Product code NIM·July 9, 2013

SYNCHROMED II

FDA Adverse Event
Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·March 23, 2015

SYNCHROMED II

FDA Adverse Event
Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 25, 2012

SYNCHROMED II

FDA Adverse Event
Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·August 13, 2015

GLP CENTRIFUGE MODULE

FDA Adverse Event
Malfunction ·ABBOTT AUTOMATION SOLUTIONS GMBH·Product code JQP·July 10, 2025

GLP CENTRIFUGE MODULE

FDA Adverse Event
Malfunction ·ABBOTT AUTOMATION SOLUTIONS GMBH·Product code JQP·December 27, 2024

GLP CENTRIFUGE MODULE

FDA Adverse Event
Malfunction ·ABBOTT AUTOMATION SOLUTIONS GMBH·Product code JQP·April 28, 2025

GLP ALIQUOT MODULE

FDA Adverse Event
Malfunction ·ABBOTT AUTOMATION SOLUTIONS GMBH·Product code JQP·August 1, 2025

GLP TRACK END

FDA Adverse Event
Malfunction ·ABBOTT AUTOMATION SOLUTIONS GMBH·Product code JQP·April 1, 2026

NANOZOOMER S360 (THIS IS AN IVDD PRODUCT, NOT SOLD IN THE U.S.)

FDA Adverse Event
Malfunction ·HAMAMATSU PHOTONICS K.K, SYSTEMS DIVISION,·Product code PSY·June 5, 2023

GLP TRACK END

FDA Adverse Event
Malfunction ·ABBOTT AUTOMATION SOLUTIONS GMBH·Product code JQP·November 14, 2024

GLP CENTRIFUGE MODULE

FDA Adverse Event
Malfunction ·ABBOTT AUTOMATION SOLUTIONS GMBH·Product code JQP·December 27, 2024

GLP CENTRIFUGE MODULE

FDA Adverse Event
Malfunction ·ABBOTT AUTOMATION SOLUTIONS GMBH·Product code JQP·June 19, 2025