BEUDAMED
    23 results · 12ms · Sources: EU EUDAMED, US FDA

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    Harmonic ACE Ergonomically-Enhanced Curved Shear, Pistol Grip, Hand Controlled, (White) 5.0mm x 36cm Ref. ACE36E Lot 122295, 122308, 122762 Unclassified

    FDA Recall
    Terminated ·Surgical Instrument Service And Savings, Inc.·Product code NLQ·May 3, 2013

    Reprocessed HARMONIC Ace +7, 5mm Diameter Shears with Advanced Hemostasis (HARH), Item Number HARH36 Product Usage: The Reprocessed HARMONIC ACE+7, 5 mm Diameter Shears with Advanced Hemostasis are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, plastic, pediatric, gynecologic, urologic, thoracic, exposure to orthopedic structures (such as spine and joint space), sealing and transection of lymphatic vessels, and other open and endoscopic procedures. The instruments allow for the coagulation of vessels up to and including 7 mm in diameter, using the Advanced Hemostasis hand controls button.

    FDA Recall
    Terminated ·Stryker Sustainability Solutions·Product code NLQ·May 8, 2018

    Harmonic Scalpel Model #'s: ETHACE14S ETHACE23P ETHACE36P ETHCS14C ETHFCS9 ETHHDH05 ETHLCS-C5 and ETHLCSC5HA Intended for use in soft tissue incisions when bleeding control and minimal thermal injury are desired.

    FDA Recall
    Terminated ·Sterilmed Inc·Product code NLQ·August 8, 2008

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

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

    Sterile Co-Flex NL 3" - Product Usage: Single Use secondary wound dressing or compression wrap.

    FDA Enforcement
    Class II ·Terminated·Andover Healthcare Inc.·October 30, 2019

    Sterile Co-Flex NL 3" - Product Usage: Single Use secondary wound dressing or compression wrap.

    FDA Recall
    Terminated ·Andover Healthcare Inc.·Product code FQM·June 19, 2019

    Sterile Co-Flex NL 4" - Product Usage: Single Use secondary wound dressing or compression wrap

    FDA Recall
    Terminated ·Andover Healthcare Inc.·Product code FQM·June 19, 2019

    Sterile Co-Flex NL 4" - Product Usage: Single Use secondary wound dressing or compression wrap

    FDA Enforcement
    Class II ·Terminated·Andover Healthcare Inc.·October 30, 2019

    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

    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

    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

    Dynavox T10 Speech Generating Device ( including Batteries)

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

    Philips GoSafe Communicator 7000L Personal emergency response system.

    FDA Recall
    Terminated ·Lifeline Systems, Incorporated·Product code ILQ·April 22, 2015

    Philips GoSafe Mobile Help Button; 7000MHB. Personal Emergency Response System.

    FDA Recall
    Terminated ·Lifeline Systems, Incorporated·Product code ILQ·July 23, 2015

    Tobii C-Series Lithium batteries Type TB8A, TB8B, TB12A used with the Tobii C8 and Tobii C12 Speech Generating Communication Devices. Communication device for the impaired and functions as a speech generating device; text or symbols can be used to generate synthesized or digitized speech. Perfect for asking or answering questions, having a conversation.

    FDA Recall
    Terminated ·Tobii Assistive Technology, Inc.·Product code ILQ·May 31, 2011

    Dynavox T15 Speech Generating Device ( including Batteries)

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