46 results · 23ms · Sources: EU EUDAMED, US FDA

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uMR Omega

FDA 510(k)
FDA Class 2 ·Radiology

LIFE SPINE LUMBAR PLATE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

PROPEP DELIVERY DEVICE

FDA 510(k)
FDA Class 2 ·General Hospital

T:SLIM X2 INSULIN PUMP

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code LZG·November 19, 2018

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·September 14, 2022

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·December 6, 2023

T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·September 4, 2020

840 VENTILATOR

FDA Adverse Event
Malfunction ·COVIDIEN, FORMERLY NELLCO·Product code CBK·June 25, 2013

PROGRAMMING WAND

FDA Adverse Event
Malfunction ·CYBERONICS, INC.·Product code LYJ·October 7, 2008

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 5, 2011

UNKNOWN STAGE ONE CEMENT SPACER MOLD

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code KWY·October 6, 2017

UNKNOWN STAGEONE CEMENT SPACER MOLD

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code KWY·October 6, 2017

UNKNOWN STAGEONE SPACER

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JDI·October 6, 2017

UNKNOWN STAGEONE SPACER

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JDI·October 6, 2017

UNKNOWN STAGEONE SPACER

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JDI·October 6, 2017

UNKNOWN STAGEONE CEMENT SPACER

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code MBB·October 6, 2017

UNKNOWN STAGEONE SPACER

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JDI·October 6, 2017

DREAMSTATION AUTO CPAP

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code BZD·January 18, 2024

MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

FDA Adverse Event
Injury ·MEDTRONIC HEART VALVES DIVISION·Product code LWR·November 4, 2016

NRG TRANSSEPTAL NEEDLE

FDA Adverse Event
Injury ·BAYLIS MEDICAL COMPANY INC.·Product code DXF·October 15, 2015