BEUDAMED
    17 results · 42ms · Sources: EU EUDAMED, US FDA

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    Relax Retractors Pty Ltd

    Manufacturer
    🇦🇺 Australia

    TRIANGULAR RETRACTOR, 80MM

    FDA Adverse Event
    Injury ·SNOWDEN PENCER DSP WORLDWIDE, INC.·Product code GAD·April 4, 1997

    DIAMOND-FLEX TRIANGULAR RETRACTOR

    FDA Adverse Event
    Malfunction ·CARDINAL HEALTH·Product code GAD·July 2, 2009

    D-FLEX TRIANGULAR RETRACTOR 80MM ANG 5MM

    FDA Adverse Event
    Malfunction ·CAREFUSION·Product code GCJ·August 27, 2015

    D-FLEX TRIANGULAR RETRACTOR 80MM 5MM

    FDA Adverse Event
    Other ·CAREFUSION·Product code GCJ·November 2, 2012

    ZOOM WHITENING LAMP AND PROCEDURE KIT

    FDA Adverse Event
    Other ·DISCUS DENTAL, LLC·Product code EEG·July 9, 2010

    HARMONIC HD 1000I SHEARS 36CM SHAFT

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·January 30, 2018

    HARMONIC HD 1000I SHEARS 36CM SHAFT

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·November 30, 2017

    DURAGEN PLUS DURAL REGENERATION MATRIX 1X3 5 PAC

    FDA Adverse Event
    Injury ·INTEGRA - PRINCETON·Product code GXQ·April 29, 2025

    HARMONIC HD 1000I SHEARS 36CM SHAFT

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·October 19, 2018

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·May 23, 2013

    TRI-STAPLE 2.0

    FDA Adverse Event
    Malfunction ·COVIDIEN LP LLC NORTH HAVEN·Product code GDW·July 27, 2023

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·November 18, 2015

    Advena Limited

    Authorized representative
    🇲🇹 Malta·467 Manufacturers·13717 Devices

    EndoWrist Stapler 45 and Stapler 30 instruments used on the da Vinci Xi systems (IS4000) with p5 software. General Surgery: The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximations, ligation, electrocautery, suturing and delivery and placement of microware and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures.

    FDA Enforcement
    Class II ·Terminated·Intuitive Surgical, Inc.·May 4, 2016

    IS3000 Vision Side Cart (VSC) used in conjunction with the da Vinci Si Surgical System IS3000. Product number 371683-05/Model Number VS3000 The Intuitive Surgical Endoscopic Instrument Control System (Intuitive Surgical da Vinci Surgical System Model IS3000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general cardiovascular and noncardiovascular thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures.

    FDA Enforcement
    Class II ·Terminated·Intuitive Surgical, Inc.·January 14, 2015

    8MM, Small Graptor REF 470318 Is a grasping retractor Instrument used with the da Vinci X/Xi Surgical Systems in a wide variety of procedures to perform a variety of surgical tasks including manipulation and retraction of tissue.

    FDA Enforcement
    Class II ·Ongoing·Intuitive Surgical, Inc.·January 22, 2025