BEUDAMED
    104 results · 52ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    Instrumed International Inc dba Avalign German Specialty Instruments

    FDA registration
    Instrumed International Inc dba Avalign German Specialty Instruments·241 products·🇺🇸 United States

    LA8513 - HOOK SUCT COAGULATOR RIGHT ANGLED 33CM

    FDA Adverse Event
    Injury ·INSTRUMED INTERNATIONAL INC.·Product code GCJ·July 27, 2015

    LA8513 - HOOK SUCT COAGULATOR RIGHT ANGLED 33CM

    FDA Adverse Event
    Injury ·INSTRUMED INTERNATIONAL, INC.·Product code GEI·July 27, 2015

    BOSS

    FDA Adverse Event
    Injury ·INSTRUMED INTERNATIONAL, INC.·Product code LRC·November 4, 2014

    INSTRUMED

    FDA Adverse Event
    Injury ·INSTRUMED INTERNATIONAL, INC.·Product code GEI·February 20, 2014

    ACF DISTRACTION SCREWS 14MM, S

    FDA Adverse Event
    Injury ·INSTRUMED INTERNATIONAL INC.·Product code LXH·August 22, 2007

    Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/ urologic closed and minimally invasive procedures. It is inserted via a trocar sleeve and is used to prepare, coagulate and cut tissue.

    FDA Enforcement
    Class II ·Terminated·Instrumed International, Inc.·October 8, 2014

    ENDOWRIST

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC·Product code NAY·April 30, 2026

    ENDOWRIST

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC·Product code NAY·May 13, 2025

    Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/ urologic closed and minimally invasive procedures. It is inserted via a trocar sleeve and is used to prepare, coagulate and cut tissue.

    FDA Enforcement
    Class II ·Terminated·Instrumed International, Inc.·October 8, 2014

    THREADED GUIDEWIRE K-WIRE

    FDA Adverse Event
    Malfunction ·INSTRUMED INTERNATIONAL INC., DBA AVALIGN GERMAN SPECIALTY INSTRUMENTS·Product code JDW·June 1, 2021

    ENDOWRIST

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC·Product code NAY·August 16, 2023

    ID NOW COVID-19 ASSAY

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·March 27, 2021

    ENDOWRIST

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC·Product code NAY·August 20, 2022

    ENDOWRIST

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC·Product code NAY·November 29, 2023

    MILLENNIUM PRATT RECTAL PROBE 73/4 SILVER

    FDA Adverse Event
    Injury ·MILLENNIUM / INSTRUMED INTERNATIONAL INC., DBA AVALIGN GERMAN SPECIALTY INSTRUMENTS.·Product code KOA·February 6, 2023

    ENDOWRIST

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC·Product code NAY·December 2, 2022

    ENDOWRIST

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC·Product code NAY·January 7, 2025

    Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/ urologic closed and minimally invasive procedures. It is inserted via a trocar sleeve and is used to prepare, coagulate and cut tissue.

    FDA Recall
    Terminated ·Instrumed International, Inc.·Product code GEI·May 30, 2014

    A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel or chamber to facilitate insertion of the cannula sold under the Symmetry Surgical, CareFusion, and Ambler Surgical brand names.

    FDA Recall
    Terminated ·Instrumed International, Inc.·Product code DRC·September 8, 2014