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

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TELESENSE

FDA 510(k)
FDA Class 2 ·Cardiovascular

APEX Knee System

FDA UDI
Omni Life Science, Inc.·00841690192848·18mm X 100mm Stem Pilot

RHEAD RADIAL HEAD EXTENDED STEMS

FDA 510(k)
FDA Class 2 ·Orthopedic

I5 DIGITAL X-RAY IMAGING SYSTEM (WITH SDX-4336CP)

FDA 510(k)
FDA Class 2 ·Radiology

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·January 5, 2023

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·November 5, 2020

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·July 5, 2022

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·June 17, 2022

SIDEKICK

FDA Adverse Event
Malfunction ·NIPRO DIAGNOSTICS, INC.·Product code NBW·September 22, 2014

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 5, 2014

CHARGING SYSTEM

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 29, 2013

UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

FDA Adverse Event
Malfunction ·BECKMAN COULTER, INC.·Product code MMI·May 26, 2011

TRUEMETRIX

FDA Adverse Event
Malfunction ·TRIVIDIA HEALTH, INC.·Product code NBW·February 15, 2019

SHARPS COLL II BD 7L

FDA Adverse Event
Malfunction ·BECTON DICKINSON IND. CIRURGICAS LTDA·Product code MMK·August 27, 2020

BD PHOENIX PMIC110

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code LON·October 19, 2021

BD PHOENIX¿ M50 AUTOMATED MICROBIOLOGY SYSTEM

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code LON·August 23, 2021

PANEL PHOENIX PMIC-110

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·June 9, 2025

BD PHOENIX PANEL PMIC-110

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·November 10, 2023

PANEL PHOENIX PMIC-110

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·June 9, 2025

PANEL PHOENIX PMIC-110

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·June 9, 2025