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

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    GSI Novus

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    NON-STERILE, POWDERED, PINK LATEX EXAMINATION GLOVES WITH CHERRY FLAVOUR AND PROTEIN LABELING CLAIMS (200 UG OR LESS)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    SAM CHEST SEAL WITH VAVLE; SAM CHEST SEAL

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    PREMICATH

    FDA Adverse Event
    Malfunction ·VYGON USA·Product code LJS·September 25, 2023

    INRATIO PT/INR TEST STRIPS

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·May 3, 2016

    INRATIO2 PT/INR PROFESSIONAL TEST STRIPS

    FDA Adverse Event
    Injury ·ALERE SAN DIEGO, INC.·Product code GJS·November 17, 2015

    INRATIO2 PT/INR PROFESSIONAL TEST STRIP

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·August 13, 2015

    INRATIO PT/INR TEST STRIPS

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·February 3, 2016

    OPTIPAC 60 REFOB BONE CMT R-3

    FDA Adverse Event
    Injury ·BIOMET FRANCE S.A.R.L.·Product code LOD·May 11, 2026

    SM104 MSERIES W5TH WHLOBS3/07

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FPO·June 17, 2013

    ACCU-CHEK SPIRIT

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS, INC.·Product code LZG·June 17, 2011

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 25, 2008

    BIOMET BONE CMENT R 1X40 JP

    FDA Adverse Event
    Malfunction ·BIOMET FRANCE S.A.R.L.·Product code LOD·May 22, 2025

    REFOBACIN BONE CEMENT R 1X40-3

    FDA Adverse Event
    Malfunction ·BIOMET FRANCE S.A.R.L.·Product code LOD·June 18, 2025

    OPTIPAC 80 BIOMET BC R

    FDA Adverse Event
    Death ·BIOMET FRANCE S.A.R.L.·Product code LOD·April 9, 2026

    BIOMET BONE CEMENT R 40 -3

    FDA Adverse Event
    Malfunction ·BIOMET FRANCE S.A.R.L.·Product code LOD·July 31, 2025

    BIOMET BONE CMENT R 1X40 JP

    FDA Adverse Event
    Malfunction ·BIOMET FRANCE S.A.R.L.·Product code LOD·June 17, 2025

    OPTIPAC 60 REFOB BONE CMT R-3

    FDA Adverse Event
    Injury ·BIOMET FRANCE S.A.R.L.·Product code LOD·February 5, 2025

    OPTIPAC 60 REFOB BONE CMT R-3

    FDA Adverse Event
    Injury ·BIOMET FRANCE S.A.R.L.·Product code LOD·February 5, 2025

    BIOMET BONE CMENT R 1X40 JP

    FDA Adverse Event
    Injury ·BIOMET FRANCE S.A.R.L.·Product code LOD·October 8, 2025