36 results · 26ms · Sources: EU EUDAMED, 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