BEUDAMED
    6,574 results · 16ms · Sources: EU EUDAMED, US FDA

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    Filters FDA Enforcement × Status: Terminated × Clear all

    O-Ring Abutment 4.1mm(D) x 2mm(H) Item: OSO20 Dental implants

    FDA Enforcement
    Class II ·Terminated·Biomet 3i, LLC·August 24, 2016

    O-Ring Abutment 4.1mm(D) x 4mm(H) Item: OSO40 Dental implants

    FDA Enforcement
    Class II ·Terminated·Biomet 3i, LLC·August 24, 2016

    O-Ring Abutment 4.1mm(D) x 6mm(H) Item: OSO60 Dental implants

    FDA Enforcement
    Class II ·Terminated·Biomet 3i, LLC·August 24, 2016

    ACIST Kodama Intravascular Ultrasound Catheter The Kodama Intravascular Ultrasound Catheter is a component of the ACIST HDi System. The ACIST HDi System is intended to be used for ultrasound examination of coronary and peripheral intravascular pathology. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures. The ACIST Kodama Intravascular Ultrasound Catheter is intended for use with the ACIST HDi System.

    FDA Enforcement
    Class I ·Terminated·Acist Medical Systems·March 10, 2021

    Gomco Circumcision Clamps with separate O-Ring Component: The device is packaged non-sterile and has no shelf-life The Gomco clamp is intended to be used for circumcision surgeries

    FDA Enforcement
    Class II ·Terminated·Aesculap Implant Systems LLC·January 11, 2017

    EXPRESS Dry Seal Chest Drain, Single Collection P/N: 4000-100N

    FDA Enforcement
    Class II ·Terminated·Atrium Medical Corporation·July 8, 2015

    Ocean Water Seal Chest Drain, SINGLE W/AC P/N: 2002-100

    FDA Enforcement
    Class II ·Terminated·Atrium Medical Corporation·July 8, 2015

    Ocean Water Seal Chest Drain, Single Collection W/AC, P/N: 2002-000

    FDA Enforcement
    Class II ·Terminated·Atrium Medical Corporation·July 8, 2015

    Oasis Dry Suction Water Seal Chest Drain, DRY SINGLE W/AC P/N: 3600-100

    FDA Enforcement
    Class II ·Terminated·Atrium Medical Corporation·July 8, 2015

    Fresenius Service Replacement 0-Ring. Used in as a service part in 4 sub-assemblies manufactured and/or refurbished Fresenius hemodialysis machines, models 2008K, 2008K2, 2008K@Home and 2008T

    FDA Enforcement
    Class II ·Terminated·Fresenius Medical Care Holdings, Inc.·July 17, 2013

    Replacement floor locking cylinders for the Schaerer model 7300 surgical tables. Replacement cylinders are part number 85118. Product Usage: The cylinders are used to lock the surgical table in place.

    FDA Enforcement
    Class II ·Terminated·Schaerer Medical USA Inc·November 16, 2016

    SYSTEM 1E Liquid Chemical Sterilant Processing System, Distributed by STERIS Corporation, Mentor, OH The SYSTEM 1E Liquid Chemical Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reusable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories.

    FDA Enforcement
    Class II ·Terminated·Steris Corporation·January 8, 2014

    FUJINON ED-530XT. This device is intended for the visualization of the duodenum and upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.

    FDA Enforcement
    Class II ·Terminated·Fujifilm Medical Systems U.S.A., Inc.·October 4, 2017

    The surgical table is a stand alone unit. Three (3) floor locking cylinders are attached to the base of the surgical table. The individual cylinders are replaceable. Product Usage: The cylinders are used to lock the surgical table in place.

    FDA Enforcement
    Class II ·Terminated·Schaerer Medical USA Inc·November 16, 2016

    GE Healthcare, Invasive Blood Pressure Care Cables. Product ID Number: 2016995-001, 2016995-002, 2016995-003, 2016995-004.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·July 25, 2012

    ENF-GP2 Rhino-Laryngo Fiberscope - Product Usage: is indicated for use within the nasal and nasopharyngeal lumen.

    FDA Enforcement
    Class II ·Terminated·Olympus Corporation of the Americas·June 17, 2020

    Cardinal Health NPWT Canister with Gel 300cc, Prescription Only - Product Usage: The systems are intended for use on patients with chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. The Cardinal Health NPWT PRO family of systems provides care in the acute, extended and home care settings.

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·July 15, 2020

    Cardinal Health NPWT Occlusion Detection Canister 300cc, Prescription Only - Product Usage: The systems are intended for use on patients with chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. The Cardinal Health NPWT PRO family of systems provides care in the acute, extended and home care settings.

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·July 15, 2020

    Pentax Video Duodenoscope Model: ED-3490TK (UDI of design being recalled: 04961333232420) These instruments are intended to provide optical visualization of (via a video monitor), and therapeutic access to, the biliary tract via the upper GI tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: esophagus, stomach, duodenum, common bile, hepatic, and cystic ducts.

    FDA Enforcement
    Class II ·Terminated·Pentax of America Inc·February 28, 2018

    CORAIL AMT COXA VARA NECK SEGMENT (KLA) Pro. Code L20432 Product Usage: The affected CORAIL Neck Trials are surgical instruments used in CORAIL total and partial hip arthroplasty.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·April 17, 2019