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

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    NATURAL-HIP SYSTEM POROUS STEM WITH HA/CSTI

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    artegral

    FDA UDI
    Merz Dental GmbH·D7091970300·anteriors; shade C2; mould BIL

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690190035·3 Degree and 5 Degree Tibial Recutting Block

    JUMP START, MODEL 970300

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    F.A.S.T. 1

    FDA Adverse Event
    Other ·PYNG MEDICAL CORP.·Product code FMI·May 30, 2006

    Restrata Wound Matrix

    FDA 510(k)
    FDA Unclassified ·Unknown

    EXPEDIUM SFX CROSS CONNECTOR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FASTI INTRAOSSEOUS INFUSION SYSTEM

    FDA Adverse Event
    Other ·PYNG MEDICAL CORP.·Product code FMI·June 10, 2009

    FAST1 INTRAOSSEOUS INFUSION SYSTEM

    FDA Adverse Event
    Other ·PYNG MEDICAL CORP.·Product code FMI·June 10, 2009

    FAST1 INTRAOSSEOUS INFUSION SYSTEM

    FDA Adverse Event
    Other ·PYNG MEDICAL CORP.·Product code FMI·June 10, 2009

    FAST1 INTRAOSSEOUS INFUSION SYSTEM

    FDA Adverse Event
    Other ·PYNG MEDICAL CORP.·Product code FMI·June 10, 2009

    FAST1 INTRAOSSEOUS INFUSION SYSTEM

    FDA Adverse Event
    Other ·PYNG MEDICAL CORP.·Product code FMI·June 10, 2009

    FAST1 INTRAOSSEOUS INFUSION SYSTEM

    FDA Adverse Event
    Other ·PYNG MEDICAL CORP.·Product code FMI·June 10, 2009

    FAST1 INTRAOSSEOUS INFUSION SYSTEM

    FDA Adverse Event
    Other ·PYNG MEDICAL CORP.·Product code FMI·June 10, 2009

    SROM STM STD 36+12L 13X18

    FDA Adverse Event
    Injury ·DEPUY IRELAND·Product code MRA·February 20, 2013

    PRECISION

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·January 14, 2011

    EMAX 2 PLUS MOTOR

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·December 11, 2013

    UniCel DxC Synchron Clinical Systems and UniCel DxC Synchron Access Integrated Clinical Systems The affected part is Part number 70300. Part number 970300 is used to transfer No Foam Solution from the No Foam Bottle to the Waste B canister and the Waste Manifold on the DxC Hydro System. Catalog No. UniCel DxC 800 Synchron Clinical Systems UniCel DxC 600 Synchron Clinical Systems UniCel DxC 600i Synchron Access Integrated Clinical Systems UniCel DxC 880i Synchron Access Integrated Clinical Systems UniCel DxC 660i Synchron Access Integrated Clinical Systems Product Labeling Reference No. A93719 For the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries.

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·August 3, 2016

    BW Lasso 2515 ANV eco Variable Diagnostic EP Catheter, REF D134301 Diagnostic electrophysiology (EP) catheters are specially designed electrode catheters that transmit electrical impulses and can be positioned for endocardial recording or stimulation.

    FDA Enforcement
    Class II ·Terminated·Stryker Sustainability Solutions·January 30, 2019

    Welch Allyn AED 10 Defibrillator; a battery powered automated external defibrillator; Manufacturer: MRL, Inc., A Welch Allyn Company, 100 Asbury Drive, Buffalo Grove, Illinois 60089; Model AED10, part numbers 970300 (defibrillator) and 970302 (defibrillator with soft shell carrying case)

    FDA Recall
    Terminated ·MRL, Inc., A Welch Allyn Company·Product code MKJ--·April 26, 2004