BEUDAMED
    21 results · 23ms · Sources: EU EUDAMED, US FDA

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    APTUS 2.0 RADIAL HEAD SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TruForm

    FDA UDI
    Rmo, Inc.·00885797099587·MAX 1ST MOLAR RIGHT 92 BANDS

    RocaFlow - Irrigation and Warming System - Single Chamber

    FDA UDI
    Promepla·03700512955177·

    Vermed

    FDA UDI
    GRAPHIC CONTROLS ACQUISITION CORP·00009336008261·Din Lead Wire, Snap to Socket, 18", Black

    ACL 9000 SYSTEM

    FDA 510(k)
    FDA Class 2 ·Hematology

    HUMI-FLOW, MODEL 6-850-00/ 01/02

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

    S5 CONTROL DISPLAY MODULE

    FDA Adverse Event
    Other ·SORIN GROUP DEUTSCHLAND·Product code DTQ·August 8, 2012

    S5 DOUBLE HEAD PUMP

    FDA Adverse Event
    Other ·SORIN GROUP DEUTSCHLAND·Product code DTQ·September 14, 2012

    S5 DOUBLE HEAD PUMP

    FDA Adverse Event
    Other ·SORIN GROUP DEUTSCHLAND·Product code DTQ·September 14, 2012

    ARIS TRANSOBTURATOR KIT

    FDA Adverse Event
    Injury ·COLOPLAST A/S·Product code OTN·July 27, 2021

    S5 DOUBLE HEAD PUMP

    FDA Adverse Event
    Other ·SORIN GROUP DEUTSCHLAND·Product code DTQ·August 29, 2012

    S5 CONTROL DISPLAY MODULE

    FDA Adverse Event
    Malfunction ·SORIN GROUP DEUTSCHLAND·Product code DTQ·May 16, 2012

    S5 CONTROL PANEL

    FDA Adverse Event
    Malfunction ·SORIN GROUP DEUTSCHLAND·Product code DTQ·May 15, 2012

    S5 CONTROL DISPLAY MODULE

    FDA Adverse Event
    Malfunction ·SORIN GROUP DEUTSCHLAND·Product code DTQ·May 16, 2012

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·April 19, 2013

    PANORAMA CENTRAL STATION WITH TELEMETRY

    FDA Adverse Event
    Malfunction ·MINDRAY DS USA INC.·Product code MHX·August 18, 2014

    9600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 11, 2011

    UNKNOWN ELASTOMERIC PUMP

    FDA Adverse Event
    Malfunction ·AVANOS MEDICAL INC.·Product code MEB·November 13, 2019

    BIOMET 3i, PROVIDE PROTECTION CAP KITS, Catalog # PAK4140, PAK4155, PAK4240, PAK4255, PAK4340, PAK4355, PAK4440, PAK4455, PAK5140, PAK5155, PAK5240, PAK5255, PAK5340, PAK5355, PAK5440, PAK5455, PAK6140, PAK6155, PAK6240, PAK6255, PAK6340, PAK6355, PAK6440, and PAK6455 BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional Abutments are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support a prosthesis in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non-occlusal loading of provisional restorations.

    FDA Enforcement
    Class II ·Terminated·Biomet 3i, LLC·January 13, 2016

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012