BEUDAMED
    18 results · 25ms · Sources: EU EUDAMED, US FDA

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    Neowise

    FDA 510(k)
    FDA Class 2 ·Radiology

    Plateau-X Spacer System

    FDA UDI
    Life Spine, Inc.·00190837016562·

    The Nanostim Introducer Kit

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VERSA-DIAL HUMERAL HEAD PROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·October 10, 2012

    SYNERGY VERSITREL

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 1, 2014

    UNKNOWN NOTTINGHAM SHOULDER

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code MBF·May 17, 2017

    INTERSTIM II

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·September 17, 2015

    SYNERGY VERSITREL

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 1, 2014

    INTERSTIM II

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·May 5, 2020

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 19, 2014

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·September 22, 2011

    ADULT DUAL HEATED BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BZE·August 2, 2013

    SYNERGY VERSITREL

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·April 30, 2014

    COMPREHENSIVE SHOULDER SYSTEM MODULAR HEAD - VARIABLE OFFSET 42MM X 18MM X 46MM

    FDA Adverse Event
    Malfunction ·BIOMET ORTHOPEDICS·Product code HSD·October 19, 2016

    On-X Prosthetic Heart Valve with Gelweave Valsalva Graft, single use. Indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic position in cases that involve an ascending aortic aneurysm or other associated aortic disease.

    FDA Enforcement
    Class II ·Terminated·CryoLife, Inc.·September 13, 2017

    Turbo Elite Laser Atherectomy Catheter Model Number / UDI-DI code / Product Description 414-151 / 989930000531 / 1.4 mm OTW 417-152 / 989930000551 / 1.7 mm OTW 420-006 / 989930000571 / 2.0 mm OTW 423-001 / 989930000591 / 2.3 mm OTW 425-011 / 989930000601 / 2.5 mm OTW 423-135-01 / 989930004171 / 2.3 mm OTW 423-135-02 / 989930004181 / 2.3 mm OTW 425-135-01 / 989930004201 / 2.5 mm OTW 425-135-02 / 989930004211 / 2.5 mm OTW The Turbo-Elite devices are indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions in humans.

    FDA Enforcement
    Class II ·Ongoing·Spectranetics Corporation·December 25, 2024

    BD PCR Cartridges used with MAX System. Model Number: 437519

    FDA Enforcement
    Class II ·Ongoing·Becton Dickinson & Co.·January 29, 2025