BEUDAMED
    16 results · 29ms · Sources: EU EUDAMED, US FDA

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    METHAMPHETAMINE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY; CALIBRATORS AND CONTROLS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    REMEL

    FDA UDI
    REMEL, INC.·00848838008771·Phenol Red Broth w/1%Dextrose w/DT 20/PK

    DRILL 1.5X105MM 22MM STP J-NT

    FDA Adverse Event
    Malfunction ·BIOMET MICROFIXATION·Product code HBE·June 16, 2021

    DRILL 1.5X105MM 22MM STP J-NT

    FDA Adverse Event
    Malfunction ·BIOMET MICROFIXATION·Product code HBE·April 28, 2021

    DRILL 1.5X105MM 22MM STP J-NT

    FDA Adverse Event
    Malfunction ·BIOMET MICROFIXATION·Product code HBE·June 4, 2021

    ADVIA CENTAUR HCV (AHCV) ASSAY

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MZO·February 20, 2014

    POLESTAR N-10

    FDA 510(k)
    FDA Class 2 ·Radiology

    FRESENIUS ARTERIAL BLOODLINE SETS FOR HEMODIALYSIS, FRESENIUS COMBI SETS HEMODIALYSIS BLOOD TUBING SETS

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    PRECISION MONTAGE MRI

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 24, 2020

    COULTER® LH 780 HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·April 16, 2013

    PLM A+3 MEDNET WRLSS

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·March 17, 2011

    LIFEPAK 20 DEFIBRILLATOR/MONITOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC.·Product code LDD·June 17, 2008

    UNKN JOURNEY PFJ KNEE IMPL

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code KRR·July 23, 2025

    JELCO HYPODERMIC NEEDLE-PRO FIXED NEEDLE INSULIN SYRINGE: a) 1.0mL 28G X 1/2" (0.33mm x 13mm), REF 4428-1 b) 1.0mL 29G X 1/2" (0.33mm x 13mm), REF 4429-1

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD Inc.·June 16, 2021

    ADVIA CENTAUR HCV (AHCV) ASSAY

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MZO·March 21, 2014

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015