BEUDAMED
    17 results · 27ms · Sources: EU EUDAMED, US FDA

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    GS-1200 GRASPING/EXTRACTING FORCEP, 10MM

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    N/A

    FDA UDI
    Smith & Nephew, Inc.·00885554008135·SOD E/S ELECTRODE 45DEG BL 133M/10

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756260251·Shoulder Immobilizer

    SCANLAN® Dilators

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159010572·Garrett Vascular Dilator

    HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LATEX EXAMINATION GLOVES - BLUE COLOR

    FDA 510(k)
    FDA Class 1 ·General Hospital

    ZYFUSE FACET FIXATION SYSTEM

    FDA 510(k)
    FDA Unclassified ·Unknown

    PARADIGM INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LZG·June 27, 2014

    STRETCHER

    FDA Adverse Event
    Malfunction ·STRYKER CORP., MEDICAL DIVISION·Product code FPO·November 10, 2010

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·December 13, 2012

    ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code NKB·January 18, 2016

    PROSTHESIS INTERVERTEBRAL DISC

    FDA Adverse Event
    Injury ·SYNTHES BRANDYWINE·Product code MJO·May 13, 2015

    PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HWC·June 7, 2013

    5.5MM TI CURVED ROD 45MM

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code NKB·February 6, 2020

    ev3 IntraStent DoubleStrut Biliary Stent, Model Number: S11-26, ev3, 4600 Nathan Lane North, Plymouth, MN 55442, Catalog Number: 90-0952-001.

    FDA Recall
    Terminated ·Product code FGE·January 18, 2008

    ev3 IntraStent DoubleStrut Biliary Stent, Model Number: S11-16, ev3, 4600 Nathan Lane North, Plymouth, MN 55442, Catalog Number: 90-0952-000.

    FDA Recall
    Terminated ·Product code FGE·January 18, 2008

    ev3 IntraStent DoubleStrut Biliary Stent, Model Number: S11-36, ev3, 4600 Nathan Lane North, Plymouth, MN 55442, Catalog Number: 90-0952-002. ev3 IntraStent DoubleStrut Peripheral Stent, Model Number: S11-36, Catalog Number: 90-1075-002 (not approved within the USA).

    FDA Recall
    Terminated ·Product code FGE·January 18, 2008

    UniCel 600/800 Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative, or qualitative determination of various analytes concentrations found in human body fluids. The cables and kits are used in UniCel DxI 600, 800 instruments, and are distributed to Beckman and Non-Beckman Service Engineers for replacement of worn and/or damaged parts during field services calls.

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·October 1, 2014