BEUDAMED
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    H&H Emergency Cricothyrotomy Kit (Part No. HHECT01/ HHECTK01, NSN 6515-01-573-0692), vacuum sealed and packaged in a 5 mil poly bags, labeled in part ***H & H Associates, Inc. CAGE 1NNH6 www.gohandh.com Ordinary, VA 23131 (800) 326-5708***. The product is used to maintain fracture alignment.

    FDA Recall
    Terminated ·H & H Associates·Product code BSK·August 27, 2013

    H&H Emergency Cricothyrotomy Kit (Part No. HHECT01/ HHECTK01, NSN 6515-01-573-0692), vacuum sealed and packaged in a 5 mil poly bags, labeled in part ***H & H Associates, Inc. CAGE 1NNH6 www.gohandh.com Ordinary, VA 23131 (800) 326-5708***. The product is used to maintain fracture alignment.

    FDA Enforcement
    Class I ·Terminated·H & H Associates·October 9, 2013

    ORA SYSTEM 2000

    FDA Adverse Event
    Injury ·ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER·Product code NCF·July 15, 2024

    ORA SYSTEM WITH VERIFEYE MESSAGING

    FDA Adverse Event
    Injury ·ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER·Product code NCF·July 1, 2024

    ORA SYSTEM 2000

    FDA Adverse Event
    Injury ·ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER·Product code NCF·June 9, 2025

    CLAREON ASPHERIC UV ABSORBING IOL

    FDA Adverse Event
    Malfunction ·ALCON RESEARCH, LLC - HUNTINGTON·Product code HQL·December 10, 2024

    CLAREON TORIC UV ABSORBING IOL

    FDA Adverse Event
    Malfunction ·ALCON RESEARCH, LLC - HUNTINGTON·Product code MJP·December 10, 2024

    ORA SYSTEM WITH VERIFEYE MESSAGING

    FDA Adverse Event
    Injury ·ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER·Product code NCF·October 17, 2024

    ORA SYSTEM 2000

    FDA Adverse Event
    Injury ·ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER·Product code NCF·October 8, 2024

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·April 10, 2019

    WAVELIGHT EX500 EXCIMER LASER

    FDA Adverse Event
    Injury ·WAVELIGHT GMBH·Product code LZS·November 25, 2025

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    FDA Adverse Event
    Malfunction ·W. L. GORE & ASSOCIATES, INC.·Product code MIH·September 28, 2023

    ORA SYSTEM WITH VERIFEYE MESSAGING

    FDA Adverse Event
    Injury ·ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER·Product code NCF·November 28, 2024

    ORA SYSTEM WITH VERIFEYE MESSAGING, CART

    FDA Adverse Event
    Injury ·ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER·Product code NCF·November 28, 2024

    MONARCH III IOL DELIVERY SYSTEM, INJECTOR

    FDA Adverse Event
    Malfunction ·ALCON RESEARCH, LLC - ALCON PRECISION DEVICE·Product code KYB·May 26, 2025

    WAVELIGHT FS200 FEMTOSECOND LASER

    FDA Adverse Event
    Malfunction ·WAVELIGHT GMBH·Product code GEX·November 25, 2025

    CONSTELLATION SURGICAL PROCEDURE PACK

    FDA Adverse Event
    Malfunction ·ALCON RESEARCH, LLC - HOUSTON·Product code LRO·January 16, 2025

    LENSX LASER SYSTEM

    FDA Adverse Event
    Injury ·ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER·Product code OOE·June 11, 2025

    CUSTOM-PAK SURGICAL PROCEDURE PACK

    FDA Adverse Event
    Injury ·ALCON RESEARCH, LLC - HOUSTON·Product code LRO·May 15, 2025

    GORE® DRYSEAL FLEX INTRODUCER SHEATH

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES, INC.·Product code DYB·December 22, 2023