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

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    PULPDENT VLC RESIN CEMENT

    FDA 510(k)
    FDA Class 2 ·Dental

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·00636257124567·15-20 MV FOR MEN CLSC CALF STD GREY VI

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·00636257126592·15-20 MV FOR MEN SEL CALF STD GREY VI

    BiomarC®

    FDA UDI
    Carbon Medical Technologies, Inc.·00858015005240·Preloaded Barbell Carbon Tissue Marker - Sidepo...

    Gladstone ALIF Trial Cage

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215045050·

    IMMAGE IMMUNOCHEMISTRY SYSTEM HIGH SENSITIVITY C-REACTIVE PROTEIN (CRPH) REAGENT

    FDA 510(k)
    FDA Class 2 ·Immunology

    SYNERGY VLS CAP NUT MODELS 2206, 6102

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CADD

    FDA Adverse Event
    Malfunction ·ST PAUL·Product code FPA·March 23, 2022

    CADD MEDICATION CASSETTE

    FDA Adverse Event
    Malfunction ·ST PAUL·Product code FPA·July 14, 2022

    CADD

    FDA Adverse Event
    Malfunction ·NULL·Product code FPA·August 17, 2021

    CADD MEDICATION CASSETTES

    FDA Adverse Event
    Malfunction ·ST PAUL·Product code FPA·June 6, 2022

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    FDA Adverse Event
    Death ·CORDIS LLC (PR)·Product code NIQ·April 8, 2013

    PEPGEN P-15 PUTTY

    FDA Adverse Event
    Injury ·DENTSPLY TULSA·Product code NPZ·May 7, 2008

    INTERLINK I.V. CATHETER EXT SET/MALE LL ADAPTER

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - AIBONITO·Product code FPA·April 5, 2011

    6.5MM TI RECON SCREW WITH T25 STARDRIVE 95MM

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HSB·April 23, 2018

    6.5MM TI RECON SCREW WITH T25 STARDRIVE 105MM

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HSB·April 23, 2018

    Integra Licox Brain Tissue Oxygen Monitoring; 1 x Dual Lumen Introducer Kit REF IP2; 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

    Integra Licox Brain Tissue Oxygen Monitoring; 1 x Complete Brain Probe Kit REF IP1.P 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

    Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IP2.P 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

    PKG, 3MM INSERT, ATRAUMATIC GRASPER, SINGLE ACTION, 29CM, P/N 0250282099 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014