BEUDAMED
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    SECURLINE UMBILICAL CORD CLAMP #3505 STERILE #3515 NON-STERILE

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

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·34546540602627·Bone Screws, MP, Cross-Pin

    Plateau Spacer System

    FDA UDI
    Life Spine, Inc.·00190837026455·PLATEAU Interbody, Straight, Bulleted, 10mm 20m...

    Plateau Spacer System

    FDA UDI
    Life Spine, Inc.·00190837009960·

    CHROMOSTREAK

    FDA 510(k)
    FDA Class 1 ·Microbiology

    ULTRA CARE 2 LATEX EXAMINATION GLOVES MADE FROM ALLOTEX (ENZYME TREATED) NATURAL RUBBER LATEX WITH A PROTEIN CONTENT LAB

    FDA 510(k)
    FDA Class 1 ·General Hospital

    ZILVER 635 BILIARY SELF EXPANDING METAL STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·December 17, 2018

    ZILVER BILIARY SELF-EXPANDING STENT

    FDA Adverse Event
    Injury ·COOK IRELAND LTD·Product code FGE·March 5, 2020

    ZILVER 635 BILIARY SELF EXPANDING METAL STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·September 26, 2018

    ZILVER 635 BILIARY SELF EXPANDING METAL STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·August 24, 2018

    ZILVER 635 BILIARY SELF EXPANDING METAL STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·August 24, 2018

    Philips and Laerdal brands of HeartStart HS1 Defibrillator Family Model number M5066A, M5067A, and M5068A Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA. The HS1 Defibrillator is intended to treat ventricular fibrillation, the most common cause of sudden cardiac arrest. Using voice prompts, light emitting diodes (LEDs) and buttons, the user is guided through the response. The HS1 uses a SMART biphasic, impedance compensating exponential waveform to deliver a nominal 150 J to adults and nominal 50 J to infants/children.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems North America Co. Phillips·January 16, 2013

    EMAX 2 PLUS MOTOR

    FDA Adverse Event
    Malfunction ·THE ANSPACH EFFORT, INC.·Product code HBC·March 18, 2013

    STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 12F/4.0MM INTRODUCER SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - CORK·Product code DTK·March 16, 2011

    DEXTRUS 4136

    FDA Adverse Event
    Injury ·BIOTRONIK GMBH AND CO·Product code DTB·March 24, 2008

    COSYCOT INFANT WARMER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code FMT·February 27, 2018

    ZILVER 635 BILIARY SELF EXPANDING METAL STENT

    FDA Adverse Event
    Injury ·COOK IRELAND LTD·Product code FGE·October 11, 2017

    ZILVER 635 BILIARY SELF EXPANDING METAL STENT

    FDA Adverse Event
    Injury ·COOK IRELAND LTD·Product code FGE·October 11, 2017

    ZILVER 635 BILIARY SELF EXPANDING METAL STENT

    FDA Adverse Event
    Injury ·COOK IRELAND LTD·Product code FGE·October 11, 2017

    ZILVER 635 BILIARY SELF EXPANDING METAL STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·August 2, 2018