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

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    MEDELA THOPAZ, MODEL 200 0288

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526743656·ACHIMED ACHILLES SUPP SILVER II

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526743489·LEVAMED ANKLE SUPPORT SILVER II

    Cook

    FDA UDI
    COOK INCORPORATED·00827002158191·Percutaneous Nephrostomy Catheter

    ITOTAL IDENTITY IMPACTOR HANDLE

    FDA UDI
    Conformis, Inc.·00810933030582·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450180747·

    Tiche PTA Balloon Dilatation Catheter

    FDA UDI
    BrosMed Medical Co.,Ltd.·06958481476798·

    neoWave LS

    FDA UDI
    XENIX MEDICAL LLC·00818345023956·PADDLE SPREADER, 12MM

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0102120·Shaver, Open 12mm

    OFFSET TIBIAL TRAY

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    KSEA CHARDONNES MORCELLATION KNIFE

    FDA 510(k)
    FDA Class 1 ·Obstetrics/Gynecology

    1080-212 ITOTAL IDENTITY IMPACTOR HANDLE

    FDA Adverse Event
    Malfunction ·CONFORMIS INC·Product code LXH·January 27, 2023

    UNIFY CRT-D

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·April 26, 2013

    PERCUNAV

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE·Product code JAK·April 7, 2011

    ADVIA CENTAUR TROPONIN ULTRA ASSAY

    FDA Adverse Event
    Other ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code MMI·July 17, 2008

    IMPACTOR HANDLE, ED-07827, CATALOG NUMBER: 1080-212

    FDA Adverse Event
    Malfunction ·CONFORMIS INC·Product code LXH·September 15, 2023

    iTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AE

    FDA Recall
    Open, Classified ·Conformis, Inc.·Product code OIY·November 14, 2022

    iTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AE

    FDA Enforcement
    Class II ·Ongoing·Conformis, Inc.·February 22, 2023

    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

    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