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

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    AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Black Silicone

    FDA UDI
    COOK INCORPORATED·00827002151468·Black Silicone Filiform DP Ureteral Stent Set W...

    Cook

    FDA UDI
    COOK INCORPORATED·00827002464407·Black Silicone Filiform Double Pigtail Ureteral...

    INSPIRE 6 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CUTERA GENESISPLUS LASER SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    BD OBTURATOR FOR VENFLON¿/SAFELON¿

    FDA Adverse Event
    Injury ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·January 4, 2016

    PARADYM

    FDA Adverse Event
    Injury ·SORIN GROUP ITALIA S.R.L.·Product code MRM·May 24, 2013

    DUAL EXTENSION

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 16, 2011

    BRAVO

    FDA Adverse Event
    Malfunction ·ARIZONA DEVICE MANUFACTURING·Product code FFT·August 20, 2008

    HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY

    FDA Adverse Event
    Malfunction ·HEARTWARE, INC.·Product code DSQ·September 26, 2018

    PLATE, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HRS·October 3, 2016

    PLATE, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code HRS·August 26, 2016

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022

    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