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

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    AERIAL™ Interspinous Fixation

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST

    FDA 510(k)
    FDA Class 2 ·Hematology

    QUANTA FLASH ACL LGA, QUANTA FLASH B2GP1 IGA

    FDA 510(k)
    FDA Class 2 ·Immunology

    TWIST CATHETER

    FDA Adverse Event
    Injury ·CURE MEDICAL LLC·Product code KOD·May 22, 2019

    ASR ACETABULAR CUPS 52

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. - 8010379·Product code KWA·June 20, 2013

    DUAL COOLER /HEATER

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DWC·July 1, 2011

    COBAS INTEGRA 400

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS CORP.·Product code JJE·September 23, 2008

    STEM: MASTERLOC CEMENTLESS TI COATED LAT SIZE 3

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·November 27, 2019

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 200 MM, Silicone, Sterile, Item 431195.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 125 MM, Silicone, Sterile, Item 431190.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014