BEUDAMED
    19 results · 22ms · Sources: EU EUDAMED, US FDA

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    EO GAS STERILIZATION PROCESS INDICATOR TAPES, MODEL CI 124

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CRANIOCAP

    FDA 510(k)
    FDA Class 2 ·Neurology

    SYNTHETIC POWDERED (YELLOW) VINYL PATIENT EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    SURGISTOOL

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FZM·March 13, 2013

    ASR UNI FEMORAL IMPL SIZE 55

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·February 16, 2011

    DA VINCI S SURGICAL SYSTEM

    FDA Adverse Event
    Other ·INTUITIVE SURGICAL, INC.·Product code NAY·February 12, 2008

    OPTIFLUX 180NR DIALYZER FINISHED ASSMBLY

    FDA Adverse Event
    Malfunction ·OGDEN MANUFACTURING PLANT·Product code KDI·July 21, 2018

    OPTIFLUX 180NRE DIALYZER FINISHED ASSMBLY

    FDA Adverse Event
    Malfunction ·OGDEN MANUFACTURING PLANT·Product code KDI·August 13, 2018

    OPTIFLUX 180NR DIALYZER FINISHED ASSMBLY

    FDA Adverse Event
    Malfunction ·OGDEN MANUFACTURING PLANT·Product code KDI·July 27, 2018

    M2A 38MM ONE-PIECE CUP 38MM X 58 O.D.

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·March 20, 2012

    M2A MODULAR HEAD COMPONENT 38MM HEAD DIAMETER

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWY·March 20, 2012

    SHAATZ PESS 3-1/4

    FDA Adverse Event
    Malfunction ·COOPERSURGICAL, INC.·Product code HHW·December 2, 2020

    MINIMED QUICK-SET

    FDA Adverse Event
    Injury ·UNOMEDICAL A/S·Product code FPA·June 24, 2024

    MINIMED QUICK-SET

    FDA Adverse Event
    Injury ·UNOMEDICAL A/S·Product code FPA·June 24, 2024

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013

    Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007296 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS

    FDA Enforcement
    Class II ·Terminated·Natus Medical Incorporated·December 21, 2016

    Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020

    Thoratec HeartMate 3 LVAS Implant Kit, Rx Only, Catalog # 106524US, 106524, 10652INT - LVAS KIT, HM 3 Indicated for providing short-term hemodynamic support in patients with advanced refractory left ventricular heart failure.

    FDA Enforcement
    Class I ·Terminated·Abbott·May 23, 2018

    Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly

    FDA Enforcement
    Class II ·Ongoing·Covidien·August 28, 2024