BEUDAMED
    16 results · 21ms · Sources: EU EUDAMED, US FDA

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    FDA 510(k)
    FDA Class 2 ·Dental

    VALUGRIP

    FDA UDI
    BENCO DENTAL SUPPLY CO.·00366975025531·ValuGrip X-Small Latex Powder-Free Exam Gloves ...

    ProLift Trial

    FDA UDI
    Life Spine, Inc.·00190837088569·

    POWER-FREE NITRILE PATIENT EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    URITEK-720+ URINE ANALYZER

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    AMIA AUTOMATED PD CYCLER SET

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKX·December 15, 2020

    AMIA AUTOMATED PD CYCLER SET

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKX·January 12, 2023

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    FDA Adverse Event
    Malfunction ·MEDTRONIC MILACA, INC.·Product code LWP·June 7, 2013

    PARADYM

    FDA Adverse Event
    Malfunction ·SORIN CRM S.R.L.·Product code MRM·June 24, 2011

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·September 10, 2008

    AMIA AUTOMATED PD CYCLER SET

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKX·February 15, 2024

    ENDOSKELETON® TCS NO 6 SWIVEL DRIVER

    FDA Adverse Event
    Malfunction ·TITAN SPINE, LLC·Product code HXX·January 28, 2016

    AERO LL FIXATION ANCHOR, 50MM

    FDA Adverse Event
    Malfunction ·STRYKER SPINE-US·Product code OVD·March 25, 2019

    iCup DX 8 Panel w/Adulterant, Item No. I-DXA-187-016

    FDA Enforcement
    Class III ·Terminated·Ameditech Inc·December 30, 2015

    Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·April 9, 2014

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012