BEUDAMED
    19 results · 22ms · Sources: EU EUDAMED, US FDA

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    EP-TRACER SYSTEM, EP-TRACER SYSTEM, EP-TRACER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Premium Surgiclip

    FDA UDI
    Covidien LP·10884521057531·Clip Applier

    Oticon

    FDA UDI
    Oticon A/S·05707131265586·TVA2, NO LOGO BL TV ADAPTER 2.0 OT

    Alice 6

    FDA UDI
    Respironics, Inc.·00606959047105·Alice 6 Base Station, LDE with Masimo, NA

    ALOE CADABRA LUBRICANT, ALOE CADABRA FLAVORED/SCENTED LUBRICANTS

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    SIDEKICK EZ FRAME EXTERNAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ENDO CLIP

    FDA Adverse Event
    Malfunction ·DAVIS & GECK CARIBE LTD·Product code FZP·January 24, 2019

    EON MINI

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 23, 2013

    DEPUY ASR XL FEM IMP SIZE 49

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·June 15, 2011

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 2, 2014

    PREMIUM SURGICLIP* M-9.75 TITANIUM

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY USSC PUERTO RICO INC·Product code FZP·April 7, 2015

    ENDO CLIP II

    FDA Adverse Event
    Malfunction ·DAVIS & GECK CARIBE LTD·Product code FZP·July 25, 2018

    H30 HOLMIUM LASER 30 WATT HOLMIUM LASER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code GEX·October 30, 2017

    H30 HOLMIUM LASER 30 WATT HOLMIUM LASER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code GEX·February 9, 2018

    H30 HOLMIUM LASER 30 WATT HOLMIUM LASER

    FDA Adverse Event
    Injury ·COOK INC·Product code GEX·February 28, 2018

    H30 HOLMIUM LASER 30 WATT HOLMIUM LASER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code GEX·February 8, 2018

    H30 HOLMIUM LASER 30 WATT HOLMIUM LASER

    FDA Adverse Event
    Injury ·COOK INC·Product code GEX·April 25, 2018

    The device is a whole-body CT x-ray system. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body taken at different angles and planes. The system also includes signal analysis and display equipment, patient and equipment supports, components, and accessories. Philips Inclusive CT has a 72cm bore and includes a detector array that provides 50cm scan field of view.

    FDA Enforcement
    Class II ·Completed·Philips North America Llc·December 27, 2023

    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015