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

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    ENCOMPASS HF100- EAGLE PANORAMIC/CEPHALOMETRIC X-RAY

    FDA 510(k)
    FDA Class 2 ·Dental

    Utrecht Interstitial Fletcher CT/MR Applicator

    FDA UDI
    Nucletron B.V.·08717213034969·Interstitial Ovoid (right) 30mm 15°, R12,5

    SPY INTRA-OPERATIVE IMAGING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    LIFESTYLES, CONTEMPO OR PRIVATE LABEL, MALE LATEX CONDOM WITH GLYCERINE LUBRICANT

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

    FREESTYLE PRECISION NEO

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC·Product code NBW·January 10, 2017

    BD LUER SLIP¿ TUBERCULIN SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FMF·February 8, 2018

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 13, 2013

    SMALL BATTERY DRIVE

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HWE·September 23, 2014

    L9000 LIGHTSOURCE

    FDA Adverse Event
    Malfunction ·STRYKER ENDOSCOPY SAN JOSE·Product code FCW·April 25, 2011

    SYRINGE 5ML LL TIP BULK CONVENIENCE PAK

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMF·January 27, 2021

    2500CC CANISTER

    FDA Adverse Event
    Malfunction ·DEROYAL INDUSTRIES, INC.·Product code KDQ·August 20, 2020

    Ultrasound Video Gastroscope, Model EG-3670URK, The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical video processor to provide images for observation, diagnosis, imaging, or therapy of the upper gastrointestinal tract from esophagus through duodenum.

    FDA Enforcement
    Class II ·Terminated·Pentax of America Inc·August 30, 2017

    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

    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