BEUDAMED
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    Welch Allyn, Inc.

    FDA UDI
    WELCH ALLYN, INC.·00732094309300·Reconditioned H12+ 12-lead digital Holter Recor...

    JP RESERVOIR KIT; SILICONE FLAT DRAIN

    FDA Adverse Event
    Injury ·ALLEGIANCE HEALTHCARE CORP.·Product code GCY·February 6, 2001

    PFNA-II BLADE L85 TAN

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code LXT·June 18, 2013

    2520274-2013-02346

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code LXH·May 3, 2013

    PFNA-II BLADE L90 TAN

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HSB·May 3, 2013

    THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code LPB·August 30, 2023

    IMPLANTABLE NEUROSTIMULATOR

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code MHY·April 8, 2020

    IMPLANTABLE INFUSION PUMP

    FDA Adverse Event
    Death ·MEDTRONIC NEUROMODULATION·Product code LKK·July 13, 2017

    IMPLANTABLE NEUROSTIMULATOR FOR SPINAL CORD STIMULATION

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LGW·July 13, 2017

    Impella CP Pump Set, Japan; Product Code: 0048-0034-JP;

    FDA Enforcement
    Class II ·Ongoing·Abiomed, Inc.·September 11, 2024

    IMPACTOR F/PFNA BLADE

    FDA Adverse Event
    Malfunction ·SYNTHES BETTLACH·Product code HWA·August 5, 2015

    Impella CP Pump Set, Japan; Product Code: 0048-0034-JP;

    FDA Recall
    Open, Classified ·Abiomed, Inc.·Product code OZD·August 5, 2024

    Impella CP Smart Assist Set, JP; Product Code: 0048-0024-JP;

    FDA Recall
    Open, Classified ·Abiomed, Inc.·Product code OZD·August 5, 2024

    System, Multipurpose For In Vitro Coagulation Studies

    FDA classification
    FDA Class 2 ·System, Multipurpose For In Vitro Coagulation Studies

    HEMOCHRON RESPONSE, 110V

    FDA Adverse Event
    Malfunction ·INTERNATIONAL TECHNIDYNE CORP.·Product code JPA·July 10, 2015

    TCOAG DESTINY MAX

    FDA Adverse Event
    Injury ·TCOAG DEUTSCHLAND GMBH·Product code JPA·July 21, 2015

    HEMOCHRON

    FDA Adverse Event
    Malfunction ·ACCRIVA DIAGNOSTICS INC., DBA ITC, DBA ACCUMETRICS·Product code JPA·September 18, 2015

    HEMOCHRON JR. SIGNATURE PLUS SYSTEM

    FDA Adverse Event
    Malfunction ·INTERNATIONAL TECHNIDYNE CORPORATION·Product code JPA·January 11, 2012

    COAGUCHEK ® S SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JPA·March 7, 2012

    HEMOCHRON ELITE MICROCOAGULATION SYSTEM

    FDA Adverse Event
    Malfunction ·INTERNATIONAL TECHNIDYNE CORP.·Product code JPA·February 13, 2012