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

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    4.5.* 6.0MM DENTAL IMPLANT AND 6.0*6.0 MM DENTAL IMPLANT

    FDA 510(k)
    FDA Class 2 ·Dental

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756045919·Esophageal Stethoscope w/Temperature Sensor

    INSPIRE 8 HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RES

    FDA Adverse Event
    Injury ·SORIN GROUP ITALIA SRL·Product code DTZ·October 13, 2016

    DIALYSATE LINE WITH CONNECTORS/RE-USE WASH-OUT LINES

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    PORTABLE INTENSIVE CARE UNIT, MODEL PIC

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    INSPIRE 8 HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VENOUS/CARDIOTOMY

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·July 4, 2019

    INSPIRE 8 HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VENOUS/CARDIOTOMY

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·February 19, 2019

    INSPIRE 8 START P

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DTZ·October 6, 2023

    INSPIRE 8 START P HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL RESERVOIR

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA S.R.L.·Product code DTZ·June 9, 2017

    EndoVive 3s Low Profile Balloon Kits Part Number: M00548280 (XMD P/N 70-0050-712) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.

    FDA Enforcement
    Class II ·Terminated·Xeridiem Mediem Medical Devices Inc·March 2, 2016

    IFUSE IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·SI-BONE, INC.·Product code OUR·October 18, 2013

    MAXCEM ELITE

    FDA Adverse Event
    Injury ·KERR CORPORATION·Product code EMA·April 10, 2013

    RIATA ST OPTIM ACTIVE FIXATION

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·May 27, 2008

    ENDOTAK C

    FDA Adverse Event
    Injury ·HISTORICAL PUERTO RICO·Product code NVY·April 12, 2011

    Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IP2.P Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Used in direct monitoring of the partial pressure of oxygen.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·October 30, 2013

    BD¿ SYRINGE S2

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·December 12, 2018

    INSPIRE 8 START P HOLLOW FIBER OXY W/ INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RES

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DTZ·February 3, 2016

    EndoVive 3s Low Profile Balloon Kits Part Number: M00548280 (XMD P/N 70-0050-712) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.

    FDA Recall
    Terminated ·Xeridiem Mediem Medical Devices Inc·Product code PIF·December 23, 2015

    Universal Chuck-The Universal Chuck is an Instrument Handle provided as an alternative instrument available for use in the TN-ADVANCED" Tibial Nailing System (TNA), TFN-ADVANCED" Proximal Femoral Nailing System (TFNA), RFN-ADVANCED" Retrograde Femoral Nailing System (RFNA), FRN-ADVANCED" Femoral Recon Nailing System (FRNA), and Flexible Monobloc Reamers. Instrument Handles are intended for holding instruments for manipulation during orthopedic surgery. Product No.: 03.043.001

    FDA Recall
    Open, Classified ·Synthes (USA) Products LLC·Product code LXH·December 22, 2021

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015