16 results
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20ms
·
Sources: EU EUDAMED, US FDA
FOLD AWAY HUT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Caiman Seal and Cut Technology
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ACUMATCH M-SERIES LPB 12/14 FEMORAL STEM
FDA 510(k)
FDA Class 2
·Orthopedic
UNKNOWN SOLITAIRE
FDA Adverse Event
Injury
·MICRO THERAPEUTICS, INC. DBA EV3·Product code NRY·December 17, 2020
ORTHOLOC(TM)
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code HRS·July 31, 2018
ORTHOLOC(TM)
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code HRS·July 31, 2018
ORTHOLOC(TM)
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code HRS·July 31, 2018
HENRY SCHEIN ONE STEP + HCG URINE STRIP TEST
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code JHI·April 11, 2014
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·October 4, 2010
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code ITI·November 29, 2012
ACUSNARE POLYPECTOMY SNARE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code KNS·May 10, 2022
ACUSNARE POLYPECTOMY SNARE SOFT
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code KNS·July 13, 2023
ACUSNARE POLYPECTOMY SNARE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code KNS·May 4, 2022
UNKNOWN NV PRODUCT
FDA Adverse Event
Death
·MICRO THERAPEUTICS, INC. DBA EV3·Product code NRY·December 17, 2020
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·February 5, 2016
PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017