36 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Central Monitoring System
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
OTOMEDICS SOFT TYMPANOSTOMY TUBE
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
MODIFICATION TO INTEL HEALTH GUIDE PHS6000
FDA 510(k)
FDA Class 2
·Cardiovascular
VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAM·November 21, 2019
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·May 20, 2022
COULTER® LH 750 HEMATOLOGY ANALYXZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·June 14, 2013
SYNCHRON LXI 725 SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code MMI·July 1, 2011
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code NIQ·September 22, 2008
MICRA
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code PNJ·January 26, 2022
RENAISSANCE SYSTEM
FDA Adverse Event
Injury
·MAZOR ROBOTICS LTD·Product code HAW·March 13, 2024
STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LGW·March 31, 2016
MEDTRONIC IPG
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code NVZ·February 18, 2025
MEDTRONIC ICD
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code DXY·February 18, 2025
HS2 SHARP HOOK BLADE SYSTEM
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·December 3, 2019
PEDICLE SCREW 8X40MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·August 11, 2020
OPTETRAK HI-FLEX TIBIAL INSERT SZ 3 9MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·March 31, 2023
NEXUS COIL
FDA Adverse Event
Malfunction
·COVIDIEN (IRVINE)·Product code HCG·October 3, 2017
NEXUS COIL
FDA Adverse Event
Malfunction
·COVIDIEN (IRVINE)·Product code HCG·October 3, 2017
NEXUS COIL
FDA Adverse Event
Malfunction
·COVIDIEN (IRVINE)·Product code HCG·October 3, 2017
NEXUS COIL
FDA Adverse Event
Malfunction
·COVIDIEN (IRVINE)·Product code HCG·October 3, 2017