46 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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