BEUDAMED
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    TissuGlu Surgical Adhesive

    FDA UDI
    COHERA MEDICAL, INC.·M690TG100US0·TissuGlu Surgical Adhesive

    TISSUGLU SURGICAL ADHESIVE

    FDA Adverse Event
    Injury ·COHERA MEDICAL, INC·Product code PJK·November 17, 2017

    TISSUGLU SURGICAL ADHESIVE

    FDA Adverse Event
    Injury ·COHERA MEDICAL INC·Product code PJK·November 17, 2017

    TISSUGLU SURGICAL ADHESIVE

    FDA Adverse Event
    Injury ·COHERA MEDICAL INC·Product code PJK·February 8, 2017

    TISSUGLU SURGICAL ADHESIVE

    FDA Adverse Event
    Injury ·COHERA MEDICAL INC·Product code PJK·November 15, 2016

    TISSUGLU SURGICAL ADHESIVE

    FDA Adverse Event
    Injury ·COHERA MEDICAL INC·Product code PJK·September 14, 2017

    TISSUGLU SURGICAL ADHESIVE

    FDA Adverse Event
    Injury ·COHERA MEDICAL INC·Product code PJK·June 12, 2017

    TISSUGLU SURGICAL ADHESIVE

    FDA Adverse Event
    Injury ·COHERA MEDICAL INC·Product code PJK·January 11, 2018

    INFRATOME HANDPIECE

    FDA Adverse Event
    Malfunction ·COHERENT MEDICAL DIV. COHERENT, INC.·Product code GEX·September 23, 1994

    INFRATOME HANDPIECE

    FDA Adverse Event
    Malfunction ·COHERENT MEDICAL, INC.·Product code GEX·May 16, 1996

    COHERENT EXCELLASE 55

    FDA Adverse Event
    Injury ·COHERENT MEDICAL LASER, INC.·Product code GEX·March 15, 1994

    ULTRAPULSE CO2 LASER

    FDA Adverse Event
    Injury ·COHERANT, INC. MEDICAL GRP·Product code GEX·January 24, 1997

    ULTRAPULSE 5000C 117 VAC

    FDA Adverse Event
    Injury ·LUMENIS, INC./COHERENT MEDICAL GROUP·Product code GEX·January 13, 2006

    VERSAPULSE POWERSUITE

    FDA Adverse Event
    Malfunction ·LUMENIS, INC. SLC (COHERENT MEDICAL INC.)·Product code GEX·February 13, 2017

    MOSAIQ System; customers with Siemens branded linear accelerators with a COHERENCE RT Therapist workspace version 2.1a and the 3rd party MOSAIQ Oncology Information System. MOSAIQ Oncology information system is owned and marketed by IMPAC Medical System, Inc. MOSAIQ is distributed by Siemens Medical Solutions USA, Inc, Radiation Oncology under a distributor contract with IMPAC Medical. Distributed by Siemens Healthcare, Concord, Ca. Product Usage: Medical charged particle radiation therapy system. The intended use of the SIEMENS branded PRIMUS, ONCOR and ARTISTE Solution family of linear accelerators systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. P

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·February 14, 2012

    LANTIS oncology Information System, an accessory to the Linear Accelerator, as part of the COHERENCE RT Therapist, but also cleared under the ONCOR Avante-Garde and Expression, as well as the syngo RT Therapist system, as part of the ARTISTE And PRIMUS system. Manufactured by IMPAC Medical Inc., Sunnyvale, CA, device distributed by Siemens Medical Solutions Oncology Care System, Concord, CA Electronic record management system as part of a linear accelerator system used to keep track of notes and database for oncology electronic medical records.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·August 21, 2009

    Artiste MV system, Part number 8139789, medical linear accelerator equipped with COHERENCE therapist RTT4.1. Medical Linear accelerator for radiation therapy. The device utilizes a console system for selecting various treatment sequences and manages commands for all motorized movement.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·July 4, 2008

    Brand Name: Novasight Hybrid System Product Name: Novasight Hybrid Catheter Model/Catalog Number: TA-06-0001 Product Description: Common Name: Diagnostic intravascular catheter Description: The Novasight Hybrid catheter is a 3Fr single use, sterile device, which will be able to perform transluminal ultrasound and optical coherence tomography imaging of adults. The catheter is capable of real-time 2D side viewing ultrasound and optical imaging acquired simultaneously providing precisely co-registered images with the ability to produce rapidly post processed rendered longitudinal images of the vessel. Packaging: The Novasight Hybrid Catheter is packaged in a packaging system including the protective packaging and the sterile barrier system.

    FDA Recall
    Open, Classified ·Conavi Medical Inc.·Product code OBJ·March 12, 2025

    SUNGO Europe B.V.

    Authorized representative
    🇳🇱 Netherlands·1571 Manufacturers·20390 Devices