19 results
·
33ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
ARTHREX MIXING AND DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
ANGEL SYSTEM WITH ASPIRATION KIT W/ ACDA
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code ORG·March 5, 2019
ARTHREX ANGEL SYSTEM WITH ASPIRATION KIT
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code ORG·May 1, 2019
CHS
FDA UDI
Smith & Nephew, Inc.·03596010061973·AMBI COMPRESSION HIP SCREW PLATE 2SL 60MM 150D
TASMIN R 12°
FDA UDI
SIGNUS Medizintechnik GmbH·04047844014943·The basic shape of the TASMIN R devices is a ho...
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587P1211240·12mm PLIF Implant 11mm Wide 24mm Length
CARDINAL HEALTH
FDA UDI
Cardinal Health 200, LLC·10885425496969·PREP TRAY
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587P12112470·12mm PLIF Implant 11mm Wide 24mm Length 7 Degrees
Scorpio
FDA UDI
Howmedica Osteonics Corp.·07613327044607·Cruciate Retaining Tibial Insert
MICROCATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
ACCUFIX TILTING RADIOTRANSLUCENT HEADHOLDER
FDA 510(k)
FDA Class 2
·Radiology
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·May 20, 2013
SPRINT FIDELIS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·June 13, 2011
BD NEXIVA CLOSED IV ACCESS SYSTEM
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS·Product code FOZ·August 14, 2008
ACCESS ACCUTNI REAGENT
FDA Adverse Event
Injury
·BECKMAN COULTER·Product code MMI·September 15, 2016
THINFLAP SYSTEM CROSS-DRIVE, SELF-DRILLING SCREW 1.5X4MM
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code GWO·April 16, 2018
Ellume COVID-19 Home Test
FDA Enforcement
Class I
·Ongoing·ELLUME LTD·November 17, 2021
Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020