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

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    CADIMPLANT

    FDA 510(k)
    FDA Class 2 ·Radiology

    Leksell Stereotactic System

    FDA UDI
    Elekta Solutions AB·07340201503478·TITANIUM FIXATION SCREW, KIT 5 PAIRS

    SOLIDEA

    FDA UDI
    CALZIFICIO PINELLI SRL·08300496040224·MISS RELAX MICRO RETE 70 SHEER, SIZE M, PAPRIKA...

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319700396·Nail Splitter 4" (10cm), straight jaws, double ...

    Gladstone ALIF Trial Cage

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215044930·

    DENTURE BASE

    FDA UDI
    AMERICAN TOOTH INDUSTRIES·D772ATI0402240·DENTURE BASE ETHNIC SH A 1-OZ LIQ&POWDER

    NPAC MULTI-USE THERMOMETER, MODEL TD400

    FDA 510(k)
    FDA Class 2 ·General Hospital

    FLUROPERM 60-OK, PARAGON HDS-OK

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    RADICAL

    FDA Adverse Event
    Malfunction ·MASIMO CORPORATION·Product code DQA·April 16, 2015

    COBAS® HIV-1

    FDA Adverse Event
    Malfunction ·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code MZF·August 28, 2025

    ACCU-CHEK ® SPIRIT COMBO

    FDA Adverse Event
    Malfunction ·ROCHE DIABETES CARE AG·Product code LZG·April 8, 2013

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·April 5, 2011

    ASCENSIA BREEZE2

    FDA Adverse Event
    Injury ·BAYER HEALTHCARE, LLC·Product code NBW·May 8, 2008

    Inegra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Tunneling Probe Kit REF IT2 Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Used in direct monitoring of the partial pressure of oxygen.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·October 30, 2013

    Ondamed Biofeedback Device, Model No. 001-00-0101 The product is a battery powered biofeedback device that is indicated for relaxation training and muscle re-education and prescription use.

    FDA Enforcement
    Class II ·Terminated·Ondamed Inc·May 16, 2018

    The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018