BEUDAMED
    20 results · 24ms · Sources: EU EUDAMED, US FDA

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    Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100240·SILICONE TUBING FOR ASPIRATING SPECULUM

    LIV LINDE INTERGRATED VALVE-PORTABLE OXYGEN SYSTEM, MODEL M706

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    MOBIS, MOVAL, SEMIAL, TETRISMODEL PEEK AND TITANIUM, KIMBA MODEL STANDARD AND MINI

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CONTOUR® NEXT

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code JJX·September 4, 2025

    EON MINI

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·October 6, 2014

    DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE

    FDA Adverse Event
    Injury ·RICE CREEK MFG·Product code OJX·June 7, 2013

    JOSTENT GRAFTMASTER

    FDA Adverse Event
    Death ·AV-TEMECULA-CT·Product code MAF·July 6, 2011

    CONTOUR® PLUS

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code JJX·February 20, 2025

    SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·April 20, 2016

    SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·April 20, 2016

    SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·April 20, 2016

    SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·April 20, 2016

    SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·April 20, 2016

    SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.

    FDA Recall
    Terminated ·Synthes (USA) Products LLC·Product code GXQ·December 8, 2015

    SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.

    FDA Recall
    Terminated ·Synthes (USA) Products LLC·Product code GXQ·December 8, 2015

    SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.

    FDA Recall
    Terminated ·Synthes (USA) Products LLC·Product code GXQ·December 8, 2015

    SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.

    FDA Recall
    Terminated ·Synthes (USA) Products LLC·Product code GXQ·December 8, 2015

    SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.

    FDA Recall
    Terminated ·Synthes (USA) Products LLC·Product code GXQ·December 8, 2015

    GE Healthcare, Discovery XR656P/N 5374989/5397837 is intended to generate digital radiographic images of the skull, spinal column, chest, abdomen, extremities and other body parts in patients of all ages.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·August 27, 2014