BEUDAMED
    19 results · 23ms · Sources: EU EUDAMED, US FDA

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    Medline Powder Free Examination Gloves (Tested for use with Chemotherapy Drugs)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Good Sense

    FDA UDI
    GEISS, DESTIN & DUNN, INC·00846036009606·GOODSENSE MULTI-PURPOSE SOLUTION 12 OZ

    Pantheon System

    FDA UDI
    ADLER ORTHO SPA·08050880238156·Pantheon Shaft L110mm

    MAYO SCISSORS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896056084·MAYO SCISSORS WITH GOLD SCREW CURVED BEVELED BL...

    Kinetic-SL Dynamic Anterior Cervical Plate System

    FDA UDI
    Life Spine, Inc.·00190837037192·14mm Variable Screw, SL-FT-SD

    WDS X-POD AND ZEN-X DIGITAL X-RAY SENSORS

    FDA 510(k)
    FDA Class 2 ·Dental

    BARZELL-WHITMORE MAROON BELLS, INC. COLO-RECTAL MOVER, MODEL 3900

    FDA 510(k)
    FDA Class 2 ·Radiology

    IONITHERMIE MIT485, MACHINE DRIVEN BODY TREATMENT

    FDA Adverse Event
    Injury ·IONITHERMIE US·Product code IRT·May 8, 2009

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011

    AED PLUS

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·September 17, 2014

    SAGITTAL SAW ATTACHMENT

    FDA Adverse Event
    Malfunction ·SYNTHES (USA)·Product code HWE·July 2, 2013

    WALLFLEX BILIARY RX FULLY COVERED STENT

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·November 12, 2009

    UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SàRL CH·Product code MNH·April 28, 2021

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAM·March 28, 2018

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAW·March 28, 2018

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EGS·May 28, 2023

    GMK HINGE TOTAL KNEE SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code KRO·March 5, 2025

    TOSHIBA Kalare Diagnostic X-Ray System K110785

    FDA Enforcement
    Class II ·Terminated·Toshiba American Medical Systems Inc·July 17, 2013

    CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assists the operator in viewing chromosomes and looking for cellular anomalies. CytoVision enables a qualified Cytogeneticist to rapidly and accurately analyze the chromosome banding pattern.

    FDA Enforcement
    Class III ·Terminated·Leica Biosystems Richmond Inc.·June 29, 2016