BEUDAMED
    35 results · 11ms · Sources: EU EUDAMED, US FDA

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    Model RG3000 and RG4000 Series Valve Integrated Pressure Regulator (VIPR)

    FDA Enforcement
    Class II ·Terminated·Western / Scott Fetzer Company·July 2, 2014

    Essential Medical Supply brand Essential Rollator with Loop Hand Brakes, models W1700B (Blue) and W1700R (Red), Four Wheel Aluminum Walker/Rollator

    FDA Recall
    Terminated ·Essential Medical Supply, Inc.·Product code ITJ·May 8, 2009

    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 Recall
    Terminated ·DePuy Orthopaedics, Inc.·Product code LXH·September 21, 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

    Peak SE Primer Kits (4 syringes per kit) manufactured by Ultradent Products, Inc, South Jordan, UT, Self Etch Primer. The product is contained within prefilled, labeled syringes in a transparent plastic container identified with an aqua, red, orange, blue and black label with black and blue print writing. Product code: 5135, 872.3200 KLE, liquid and powder mixture is a syringe-in-a-syringe delivery system. The product is used for most bonding needs in restorative dentistry. Bonds chemical cure luting and chemical cure composites, namely PermaFlo DC. Peak SE does not require a separate etching step for quality adhesion. Peak SE is also conducive for bonding to: Dentin and enamel, porcelain, metal and composite.

    FDA Enforcement
    Class II ·Terminated·Ultradent Products, Inc.·June 27, 2012

    Peak SE Primer Kits (4 syringes per kit) manufactured by Ultradent Products, Inc, South Jordan, UT, Self Etch Primer. The product is contained within prefilled, labeled syringes in a transparent plastic container identified with an aqua, red, orange, blue and black label with black and blue print writing. Product code: 5135, 872.3200 KLE, liquid and powder mixture is a syringe-in-a-syringe delivery system. The product is used for most bonding needs in restorative dentistry. Bonds chemical cure luting and chemical cure composites, namely PermaFlo DC. Peak SE does not require a separate etching step for quality adhesion. Peak SE is also conducive for bonding to: Dentin and enamel, porcelain, metal and composite.

    FDA Recall
    Terminated ·Ultradent Products, Inc.·Product code KLE·May 24, 2012

    NOVAPLUS (TM), SUCTION CANISTER, 1200cc, RIGID, WITH ELBOW, Cat. No. V71-3001, Rx only, NON-STERILE, Made exclusively for Novation by DeRoyal, 200 DeBusk Lane, Powell, TN 37849 Most commonly used during medical medical emergencies and surgery to remove fluid and secretions from a patient.

    FDA Recall
    Terminated ·DeRoyal Industries Inc·Product code KDQ·July 1, 2010

    Maquet Express Dry Seal Suction OCEAN DRAIN, SINGLE W/S Reference: 2002-300 Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help re-establish lung expansion and restore breathing dynamics. " To facilitate postoperative collection and reinfusion of autologous blood from the patients pleural cavity or mediastinal area

    FDA Recall
    Terminated ·Atrium Medical Corporation·Product code KDQ·December 23, 2016

    HomeSafe AutoAlert Pendant works in conjunction with a compatible Lifeline communicator.

    FDA Recall
    Terminated ·Lifeline Systems Company·Product code ILQ·November 13, 2017

    MedMinder Medication Dispenser- Intended to serve as a medication reminder to promote medication adherence with additional feature to communicate with emergency call center.

    FDA Recall
    Terminated ·Medminder Systems, Inc.·Product code ILQ·March 28, 2022

    The Fuhrman Pleural/Pneumopericardial Drainage Set The Fuhrman Pleural/Pneumopericardial Drainage Set consists of pigtail catheter, access needle, dilator, and wire guide. The set also includes a multipurpose tubing adapter, and three-way stopcock.

    FDA Recall
    Terminated ·Stryker Sustainability Solutions·Product code KDQ·November 17, 2015

    Maquet Ocean Water Seal Chest Drain, Single Collection w/AC Reference: 2002-100 Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help re-establish lung expansion and restore breathing dynamics. " To facilitate postoperative collection and reinfusion of autologous blood from the patients pleural cavity or mediastinal area

    FDA Recall
    Terminated ·Atrium Medical Corporation·Product code KDQ·December 23, 2016

    Arial Wireless Water-Resistant Call Pendant The Arial Pendant tag is part of the Arial wireless emergency call management system. It enables residents in assisted living, skilled nursing or independent living to call staff with the press of a button.

    FDA Recall
    Terminated ·Stanley Security Solutions Inc·Product code ILQ·June 22, 2016

    Philips Lifeline Personal Help Button Pendant Classic and Slimline Style.

    FDA Recall
    Terminated ·Philips Lifeline Inc·Product code ILQ·September 11, 2009

    P10 Tobii battery box (product number 510410) Product Usage - Battery pack for MyTobii P10 Device. MyTobii P10 is a portable eye-controlled communication device featuring the Tobii Eye Control system.

    FDA Recall
    Terminated ·Tobii Assistive Technology, Inc.·Product code ILQ·January 14, 2013

    Responder 5 is a nurse call communication system that connects patients with staff in a hospital. The nurse call system also connects team members and departments from radiology, physical therapy, transport, environmental services and more. Responder 5 is used in hospitals and long term patient care facilities to allow for remote communications between patients and patient monitoring devices and healthcare providers

    FDA Recall
    Terminated ·Rauland-Borg Corp·Product code ILQ·May 10, 2013

    ATEC CANISTER. Suction Canister with Lid 490 cc., RX Only; Suction canister used to collect fluid during a breast biopsy.

    FDA Recall
    Terminated ·Hologic, Inc·Product code KDQ·May 31, 2016

    Voalte Nurse Call System provides a comprehensive communication and information system that places patient calls, staff calls, and emergency calls.

    FDA Recall
    Terminated ·Baxter Healthcare Corporation·Product code ILQ·April 13, 2022

    PleuraGuide Disposable Chest Tube Kit; Product codes: 17100, 17150, and 17200. Indicated to assist with the insertion of thoracic catheters.

    FDA Recall
    Terminated ·Atrium Medical Corporation·Product code KDQ·July 16, 2013

    Dynavox T10 Speech Generating Device ( including Batteries)

    FDA Recall
    Terminated ·Dynavox Systems Llc·Product code ILQ·December 14, 2017