21 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MICRUS MICROCOIL SYSTEM, DELTAPAQ 10 STRETCH RESISTANT
FDA 510(k)
FDA Class 2
·Neurology
Mapleson Anesthesia Breathing Circuit
FDA UDI
MERCURY ENTERPRISES, INC.·10641043803790·
BD INSYTE-N AUTOGUARD SHIELDED IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·August 29, 2020
MODOFICATION TO AFFFINITY 38 MICRO ARTERIAL BLOOD FILTER WITH CARMEDA BIOACTIVE SURFACE, MODELS CB351/CB352
FDA 510(k)
FDA Class 2
·Cardiovascular
IL TEST FREE PROTEIN S
FDA 510(k)
FDA Class 2
·Hematology
WAVEWRITER ALPHA?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·March 12, 2026
INSYTE-N AUTOGUARD WINGED YEL 24GAX.56IN
FDA Adverse Event
Malfunction
·Product code FOZ·July 15, 2021
BD INSYTE-N AUTOGUARD SHIELDED IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·December 16, 2020
INSYTE-N AUTOGUARD WINGED YEL 24GAX.56IN
FDA Adverse Event
Malfunction
·Product code FOZ·August 18, 2021
EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT-FULLY COVERED
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code ESW·March 25, 2015
ARTICULEZE M HEAD 36MM +8.5
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8080379·Product code JDI·January 13, 2017
PINNACLE MTL INS NEUT36IDX54OD
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8080379·Product code KWA·January 13, 2017
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 26, 2013
PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·May 6, 2011
1-DAY ACUVUE
FDA Adverse Event
Injury
·VISTAKON·Product code LPL·July 21, 2008
EVOLUTION BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FAD·March 12, 2015
EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT - FULLY COVERED
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code ESW·November 12, 2014
EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT - FULLY COVERED
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code ESW·November 27, 2014
EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT - FULLY COVERED
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code ESW·November 24, 2014
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014