BEUDAMED
    20 results · 31ms · Sources: EU EUDAMED, US FDA

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    MONEBO AUTOMATIC ARRHYTHMIA DETECTION SOFTWARE LIBRARY, VERSION 1

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HALYARD

    FDA UDI
    GRI Medical & Electronic Technology Co., Ltd.·16931918179254·Valueselect* Standard Surgical Gown_XXL_X-Long_...

    ACON MOP ONE STEP OPIATE TEST STRIP, ACON MOP STEP OPIATE TEST DEVICE

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    BIOTEQUE VAGINAL DILATOR

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    PENUMA IMPLANT

    FDA Adverse Event
    Injury ·NATIONAL MEDICAL DEVICES INC.·Product code MIB·March 1, 2018

    FR CLERMONT FERRAND

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DTZ·October 3, 2012

    MERCY HSP PITTSBURGH PA 1

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DWE·May 7, 2009

    HCSG/HENDRICK MED/ABLNE TX 1

    FDA Adverse Event
    Malfunction ·SORIN GROUP USA, INC.·Product code DWE·February 16, 2010

    DIDECO COMPACTFLO EVO

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DTZ·January 16, 2013

    DIDECO COMPACTFLO EVO

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code KFM·December 13, 2012

    DIDECO COMPACTFLO EVO

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DTZ·October 18, 2012

    HAMMER 500 GRAMS

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code FZY·April 9, 2013

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 28, 2011

    FLEXTEND IS-1 BI POSITIVE FIX

    FDA Adverse Event
    Injury ·CARDIAC PACEMAKERS, INC·Product code DTB·May 8, 2008

    EPD 60000 RPM

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HWE·June 27, 2017

    DRILL BIT Ø1.8 F/MATMAND L125 2FLUTE F/0

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code DZI·September 3, 2013

    CABLE 3M TO CONSOLE

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HWE·October 16, 2014

    Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·May 8, 2024

    Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·May 8, 2024

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012